Covid-19

CRO Strategic Partnerships

How Life Sciences CROs Are Changing To Strategic Partners: The Covid-19 Effect

How Life Sciences CROs Are Changing To Strategic Partners: The Covid-19 Effect 1500 1000 Xcelpros Team

At a Glance

  • The biotechnology and life sciences industry is at a cusp of major changes due to COVID-19. There is a lot of fluidity built up due to the pandemic and a huge dependency on government rules, FDA regulations, intricate drug production and overall research and development.
  • These firms are looking for Contract Research Organizations (CROs) who can take the role of strategic partners that can manage their life sciences research & development. The preference of CROs has already shifted from traditional to technologically adaption that can handle the rapid pace needed due to the existing COVID-19 emergency.
  • The call for innovation and increased collaboration among CROs has led to the onset of a new, more comprehensive era of project management. It is improving customer engagement and experience.

The Role of a Contract Research Organization

Project management is the backbone of any contract research organization. Regardless of its specialty–biopharmaceutical development, commercialization, preclinical research, clinical research, clinical trial management or pharmacovigilance-all require project management. Pharmaceutical and life sciences companies outsource research and development work to CROs for better time management, test data maintenance and focus on concrete results.

While the role of CROs was not very well defined in the early 2000s, they have evolved from being mere project management vendors to strategic partners for life science organizations. Contract work is now common in various steps of the research life cycle. Adding contractors is now a necessity for the R&D wings of any biotechnology or pharmaceutical company.

Active engagement with CROs helps accelerate the drug development process. In the Covid-19 era, these CROs must be prepared to streamline their project work without a process breakdown.

CROs have evolved from a target-based model to become more a strategic partner to life sciences and biotechnology companies.

Pharmaceutical companies conduct sponsored trials, driving their products safely and quickly to the market. Initially, these projects were outsourced to CROs with a limited scope of time and budget management. Now the CROs are expected to manage risks and maintain transparency throughout the clinical trials. The rapidly expanding biochemical industry demands that CROs keep up with market conditions.

According to contract research organizations global market report, The global market for clinical trial services to biopharmaceutical, biotechnology and medical device companies is forecast to grow at 12% year on year up to 2021.

This stat is already obsolete. The need for contract research and development services is increasing as life science companies seek to find effective treatments and possible cures for the SARS Covid virus.

Figure: 1 Steps for Right Partner Selection

Steps for Right Partner Selection

Growth and general technological disruptions in project management are leading to a progressive change in the roles of CROs while managing sponsored clinical trials.

Situations affecting CRO evolution

  • End-to-End Strategic Partnerships: CROs are no longer just outsourced vendors for life sciences companies to carry out Pharma research or conduct clinical trials. CROs are now expected to become pharma companies’ strategic partner, helping make their clients successful. End-to-end coordination with pharmaceutical companies gives these organizations the time and stability they need to focus on core research. Coordinating from the start helps the CROs capture the right kind of clinical data required to make each drug commercially viable.
  • Bringing Innovation to the Table: CRO project management is not just about completing given tasks while meeting their clients’ deadlines. Working closely with their customers means changing how they work. That in turn requires newer project management approaches that take research from start to finish. Pharmaceutical companies expect innovative, out-of-the-box solutions to manage risks, cut costs and push the boundaries of paramedical science while complying with the government’s rules and regulations. An important change is that CRO project management has moved from being reactive and solving problems to becoming proactive, anticipating problems and providing solutions.

Figure: 2 Key Parameters CROs are Assessed on

Key Parameters CROs are Assessed on

  • Being Technologically Ahead: Companies can start with three main technology initiatives: transitioning to cloud computing; creating strong workflows to move processes and procedures forward; using online collaboration tools.
  • Each of these above points leads to faster results, fewer errors, better team management and overall improved communication between the client and the CRO during the project life cycle.

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Customer Experience and Engagement

A crucial part of project management is actively engaging clients when a project requires collaboration. Customer experience and engagement can no longer be ignored. Making a strategic partnership work requires communication between everyone involved.

An effective customer experience approach requires knowing what to do, how to do it and using every available tool to create acceptable results.

Connect your processes, customer data and tools with Dynamics 365 and the Microsoft Cloud

Customer Experience (CX) and Customer Engagement (CE) can be made better for a CRO

01.Process and Procedures

Some ways to improve the customer experience and boost customer engagement are:

  • Improving team management
  • Quick onboarding of clinical trial experts
  • Using effective cost management techniques
  • Proactively managing clinical trial risks
  • Mitigating probable risks strategies
  • Using detailed analytics to monitor, report and understand research data
  • Using resource planning tools to optimize resources for multiple projects
  • Simplifying milestone-based billing
  • Improving deviation-tracking methods to remove unknowns early in the project lifecycle.

Life science CROs should consider using a next-generation customer experience platform to accelerate development and drive demand. Microsoft Dynamics 365 is one such system that offers the essential tools and capabilities in one comprehensive ecosystem.

The seamless integration between Dynamics 365, robust cloud computing, artificial intelligence and tools such as Office 365 can help. Dynamics 365 is a class-leading life science customer engagement platform that functions across mobile devices, which is a large market need.

02.Digital Advancement

To enhance their customer experience and engagement, companies should:

  • Move from legacy systems to the cloud
  • Use advanced analytics for risk prediction and mitigation
  • Systematically manage their R&D database with digital applications
  • Use software tools to Improve collaboration with clients
  • Reduce human intervention and automate project management workflows
  • Create customer and supplier self-service portals to engage both
  • Use in-line reporting through key project milestones to build trust and visibility with customers

03.The Inevitable Evolution

The changing role of CROs is leading to greater expectations from life sciences clients. Pharmaceutical companies are looking for CROs that are not afraid to push boundaries and are adept at using the latest tools and techniques.

Companies aiming for greater customer satisfaction can use cutting-edge technologies to engage with CRO’s at an integral level. As a result, CROs are becoming be more innovative and agile in their project management approach.

Having an interdependent relationship helps with clinical trials while also improving the client company’s overall research and development. A well-managed and organized workflow-based environment helps contractor and client.

Two tools that can help build this interdependency are Microsoft Dynamics 365 Finance combined with D365’s Supply Chain Management. The two modules can help create a comprehensive system to aid a CRO in becoming better strategic partners with Pharma and Biotech companies.

Figure: 3How to Create Successful Sourcing Partnerships?

How to Create Successful Sourcing Partnerships

Increase your speed of business with unified processes and predictive analytics

The speed of doing business is increasing. As companies seek to stay competitive, they must rely on technology to provide agility and the capabilities needed to excel. However, many organizations are still running on ERP systems that are complex, inflexible and impede their ability to innovate and grow.

Microsoft Dynamics 365 helps you to

  • Elevate your company’s financial performance and streamline its supply chain management
  • Innovate with connected operations in an extensible platform
  • Drive HR operational excellence through organizational agility and centralized data
  • Unify the processes listed above with predictive analytics and intelligence
  • Track and trace inventory management
  • End-to-end customer project management

Key Takeaways

CROs are transforming from time-bound project management consultants into performance and results-oriented firms.

  • As technology evolves, so do project management tools. CROs are equipping themselves with these tools for better time management, budget management and risk mitigation.
  • Technology allowing smoother customer and supplier onboarding for clinical trials is needed now, today.
  • Pharmaceutical companies are looking for CROs able to manage R&D projects end-to-end while also providing innovative solutions.
  • While time management and cost management will always be top priorities for CROs when it comes to any project, they must also offer greater returns to their clients.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

supply chain disruption management

How to Manage Operations During Supply Chain Disruptions

How to Manage Operations During Supply Chain Disruptions 1920 1080 Xcelpros Team

Introduction

Even today, Covid-19 continues to disrupt every level in supply chains, across every industry around the world. The lasting effects on supply chains was unanticipated, especially concerning food and cleaning supplies. Manufacturers in those areas had an unexpected spike in demand that couldn’t be managed quickly.

The overall supply chain disruption caused many companies to start re-evaluating action plans. Areas being closely examined today include production capacity, cash flow and overall employee morale.

Let’s look at how businesses can leverage existing practices while pivoting to newer methods and meeting evolving customer needs.

Figure: 1Surviving the Supply Chain with a Digital and Analytical Backbone

Surviving the Supply Chain with a Digital and Analytical Backbone

Communication and Collaboration

The first quarter of 2020 brought new dynamics to manufacturers and distributors everywhere, faced with a challenge the likes of which have never been seen before. As market dynamics changed, internal communication became critical at every stakeholder level: management, employees, customers, suppliers and vendors. Creating a communication strategy that could work when people stopped meeting face to face became vital to avoid business breakdowns and shutdowns.

That was 2020. The lingering effects of Covid-19 are still impacting some companies’ technology roadmap plans. However, there are ways to drive innovation and growth. Regardless of industry, many organizations realize the importance of doing business from anywhere. That flexibility to work on the move is no longer a luxury: it is a necessity. Unconventional work schedules are becoming more common as companies adjust to meet customer expectations. Companies are engaging them with messaging and video call software such as Microsoft Teams. They use software such as Power Automate to deploy safety alert messages whenever the need arises.

Customer and vendor portals equipped with Microsoft Dynamics 365 Supply Chain Management let companies collaborate, determine product access and make accurate forecasts without having to pick up the phone. Instead of days or weeks of delays, modern software helps firms resolve supply chain disruptions at a moment’s notice.

Manufacturers using Microsoft Dynamics 365 Supply Chain Management can integrate Internet of Things (IoT)-enabled devices and robots into their current operations. Using machine learning adds even more automation.

Connecting data and processes with Microsoft’s wide selection of products allows production and maintenance teams to schedule downtime when it has the least impact on production. Outlook messages and alerts let production staff stay on top of any possible repair issues.

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Agile decision making

Manufacturers must respond to the rapid changes in customer demands and delivery expectations. Having a robust system lets that happen.

Changes to your customers’ business demands can affect your supply chain. Having the ability to act quickly while still providing exceptional customer service is critical to future business success.

One way to prepare for these changes is by having internal cross-functional teams practice scenario planning. For example, they can plan what to do if a new Covid-19 variant appears and governments reinstate drastic safety measures.

Scenario planning lets your staff learn what to do when normal deliveries are delayed or rerouted, such as what happened when the Suez Canal was blocked for a week. It lets your staff examine past customer and supplier behaviors and come up with plans to minimize disruptions using what they learned.

Microsoft Dynamics 365 Supply Chain Management includes tools designed specifically for scenario planning. It helps companies adjust to unexpected changes in their supply chains. These tools include:

  • Drag and drop Gantt charts for production scheduling
  • 360 degree view into capacity, identifying bottlenecks in terms of people and resources
  • Adjusting safety stock to reflect real-time demands instead of fixed quantities
  • A vendor portal with approved suppliers listed in a supplier resource management database that includes purchase order controls
  • Visibility into warehouse operations for single and multi-site facilities
  • Transportation management
  • A customer portal with sales order management

Incorporating Data

Data in today’s operations is a moving target. Making decisions and providing insights with real-time information helps companies operate efficiently, letting them grow and scale at the right times. Identifying organizational segments that require optimizing, like the handoffs between operations and finance, can only occur when accurate information is available.

For example, the only way to truly analyze cash flow—to get a 360-degree view—is by looking at data within each division.

This is where a business analysis tool like Power BI becomes an essential part of the process. Power BI dashboards using predictive analytics in the Dynamics 365 environment automatically update with the latest data. These dashboards let companies monitor the status of multiple locations at once, saving time.

Tools such as Power BI let management share data, communicate and respond to changes in the market within minutes, not days.

Final thoughts

The coronavirus is the first disruption of its kind faced by this generation. Companies were caught unprepared, being forced to adjust almost instantly to upheavals in their supply chains. Having the right tools in place to deal with Reduced workforces internally and within the supply chain, pivoting production to new products and unprecedented customer product demand helps determine who flourishes and who fails.

With that in mind, it’s critical to consider implementing products from Microsoft’s family of partner solutions. Dynamics 365 and related products help companies predict and manage their operations transparently.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Revamping Your Cloud Data Strategy

Top Reasons To Revamp Your Cloud Data Strategy

Top Reasons To Revamp Your Cloud Data Strategy 2400 900 Xcelpros Team

Introduction

More and more companies are moving to the cloud for easy data storage and to boost technology innovations. Modern businesses understand the strategic competitive advantage and availability of customized applications to suit their needs. Especially during the ongoing COVID-19 crisis, many companies are considering letting go of their onsite infrastructure and hardware, opting instead to store their data on remote servers, a process known as cloud storage.

Cloud storage makes sense for business survival, pushing all enterprises to move faster. Going forward, more and more companies will need experts who understand what cloud computing is and how it can help their business. These same people monitor and implement an organization’s end-to-end cloud computing journey.

Now more than ever cloud migration is imperative to avoid glitches in infrastructure, as the market is trying to survive the pandemic.

Figure: 1Key reasons companies are switching their operations to cloud

Key reasons companies are switching their operations to cloud

In an Aug. 2, 2021 report, Gartner compared worldwide public cloud services end-user spending and 2022 forecasts, which suggest:

  • $171,915 million for Cloud Application Services (SaaS)
  • $121,620 million for Cloud System Infrastructure Services (IaaS)
  • $100,636 million for Cloud Application Infrastructure Service (PaaS)

Many companies are looking at how they can focus on their technological and process reengineering needs. Why consider revamping your cloud strategy and what steps should you take to successfully complete the reboot?

Figure: 2Factors that drive a cloud transformation

Factors that drive a cloud transformation

5 Reasons to Revamp Your Cloud Strategy

There are five main reasons to revamp your cloud strategy today:

  1. 1.Becoming more agile in terms of the ability to adjust to customer orders
  2. 2.Better position to adopt next-generation software
  3. 3.Monitoring the transition in terms of equipment and people
  4. 4.Improving data security
  5. 5.Building a skilled worker base

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Becoming more agile

Every organization has a specific roadmap layed out to fulfill the big picture of their IT landscape. Being agile lets your company quickly change the pace at which it adapts the transformative–and at times, disruptive—process of moving into a cloud-centric architecture. By restructuring your cloud strategy, IT departments can move from slowly delivering big, single-origin and rigid applications to rapidly deploying flexible, smaller applications. Some people call this process, “byte-sized transformations.”

Revamping your cloud transformation also affects your software development lifecycle. Making changes helps make the company and its staff more nimble. It can conduct continuous development (CD) and continuous integration (CI) using the DevOps model to boost your overall business.

Better position to adopt next-generation software

The future of cloud computing is all about speeding up the process of application development. Companies are adopting cutting-edge technological advancements like artificial intelligence (AI), Internet of Things (IoT), data analytics and machine learning (ML). An organization’s strategists must determine if their IT roadmap can access and use these cloud-native solutions.

In today’s virtual world, everything is connected. A rapid innovative delivery model is needed to predict future customer demand after analyzing historical data. Your company IT team can achieve its goal with better accuracy by starting with cloud transformation and ending at the ultimate goal: full optimization.

Cloud technologies like Microsoft’s Azure, and Power Platform efficiently handle day to day business operations while also letting your company work toward its long term strategic vision.

Monitoring the transition

No matter what solutions your organization decides to employ, the changeover needs to be watched carefully. Implementing a cloud strategy affects the organization and its people. The entire update needs intricate monitoring of the transformation through:

  • An infrastructure supporting the organization’s cloud journey.
  • On-boarding experts who train workers while implementing the upgrades, boosting the staff’s digital skill levels.

One way to achieve your goals is a willingness to alter your implementation strategy so it aligns your roadmap with a comprehensive cloud transition plan.

Figure: 3Companies are expecting a holistic development in operations from hybrid cloud

Companies are expecting a holistic development in operations from hybrid cloud

“Through 2022, at least 95% of cloud security failures are predicted to be the customer’s fault.”Source: Gartner

Improving data security

The instant data moves online, companies start worrying about security and data privacy. Backing your cloud strategy with a robust infrastructure like Microsoft Azure ensures the security, authenticity and longevity of your organization’s data, processes and applications is not compromised. The Azure platform is continually evaluated and updated automatically to protect against potential security threats.

Building a skilled worker base

Moving away from in-house technology to the cloud can impact roles, responsibilities and accountability across a company’s organization. Having a strategic plan to make the move should also include making sure workers are able to take advantage of the new technology.

Especially when it comes to Customer Service, the relationship between companies and their customers is more than just “order to shipments.” Solutions like Microsoft Dynamics 365 Finance use artificial intelligence and predictive analytics to more accurately forecast customer behaviors and needs.

Steps to Revamp Your Cloud Strategy

While every organization has its set of challenges and requirements when it comes to strategic rethinking of its cloud journey, some pointers to remember are:

  • Build and update your employees’ skills to ensure your organization’s cloud migration is successful. A comprehensive, organization-wide training plan is an integral part of any migration.
  • It’s ok to make the change one step at a time to make it easier to move from older programs to newer ones.
  • Take advantage of predictive data analytics to preempt the expected technical and operational glitches.
  • Define your cloud milestones before starting your migration. Stick to them. Your strategic roadmap to cloud reboot is going to be as unique as your requirements.
  • Create a blueprint of the cloud revamp and let it guide you at the pace of your employees’ ability to accept the changes.
  • Hire highly-skilled subject matter experts to make the end-to-end implementation of a new cloud strategy as smooth as possible.

Revamping your cloud strategy may sound unnecessary but following these suggestions will benefit your organization. Taking in a broader, “30,000-foot view” of the core of your cloud journey makes it easier to create your transformative blueprint.

Figure: 4 Strategies to successfully complete the cloud transition

Strategies to successfully complete the cloud transition

Key takeaways

  • Cloud infrastructure is a comprehensive and disruptive technology that helps businesses operate more efficiently.
  • Rethinking your cloud architecture helps you achieve your cloud computing goals.
  • Ensure your transition is compatible with cloud-native solutions such as IoT, AI and machine learning.
  • Moving to the cloud works better when your staff knows how to get the most out of it.
  • For added security, many organizations take advantage of products like Microsoft Azure.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

DISCLAIMER:

All statements and/or opinions expressed in this article were based on experience and / or third party materials available to the authors which formed the basis of such statements/opinions. XcelPros does not warrant the accuracy, completeness, or reliability of such underlying information (or the Company’s interpretation thereof) which has formed the basis of the Company’s and/or author’s opinion. We strongly recommend that you consult an expert from XcelPros before you take action as a result of this collateral.

Jump-starting resilient and reimagined operations

Jump-starting resilient and reimagined operations

Jump-starting resilient and reimagined operations 2400 900 Xcelpros Team

Jump-starting resilient and reimagined operations

Based on a wonderful piece from our friends at McKinsey, describing the effort needed by businesses moving forward after COVID disruptions. A reminder that businesses able to maintain a certain level of speed during the transition can create a significant long-term advantage.

Get a free consultation to learn more about building resilient operations for your company.

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How Pharmaceutical Companies Get New Products to Market during Covid-19

How Pharmaceutical Companies Get New Products to Market during Covid-19

How Pharmaceutical Companies Get New Products to Market during Covid-19 1202 452 Xcelpros Team

Introduction

As the world continues to deal with one of the deadliest pandemics in modern history, governments are working overtime to protect their citizens from the deadly disease known as Covid-19.

With the potential impact of Covid-19 on pharmaceutical sales estimated to be huge, two types of drugs are being sought after:

  • Vaccines to keep humans from catching the disease
  • Therapies to treat people with the disease and help them recover

At the end of 2020, the U.S. Food and Drug Administration (FDA) modified its approval process for vaccines, issuing an emergency use authorization (EUA) to Pfizer-BioNTech for a vaccine to prevent coronavirus disease 2019 (COVID-19). The initial EUA applied to vaccines for people 16 and older. It was further modified on May 10, 2021 to include adolescents ages 12-15. The EUA lets the vaccine be distributed in the US. Similar documents were issued to Moderna, Inc. and Johnson & Johnson / Janssen. On July 9, 2021, Pfizer said it would seek approval for a booster shot to target the newer variants of the disease. The FDA and other regulators have, at this time, disagreed with the need for it. This could result in Pfizer share price climbing by as much as 66% in 2021, as suggested by analysts from investors.com

Companies might want to rethink their pharmaceutical product launch strategies. This change in the FDA approval process may require changes in pharmaceutical new product launch plans, prioritizing Covid-19 treatments over other medicines. These plans affect not only products sold in the U.S. but also in the Indian pharma market with its 1.4 billion residents (four times that of the U.S.).

Using enterprise resource planning (ERP) software can help pharmaceutical companies gain regulatory approval of their drugs and treatment plans.

By the Numbers

Expected 2021 sales from Covid-19 vaccine makers:

  • $15 billion-$30 billion: Pfizer/BioNTech (share price +1.8% for Pfizer, +156% for BioNTech)
  • $18 billion – $20 billion: Moderna (share price +372%)
  • $10 billion: Johnson & Johnson (share price +7.7%)

Five other companies are also making Covid-19 vaccines but none have been approved by the FDA yet. (Source: The Guardian)

Normal Drug Development Process

The normal pharma go to market strategy requires a clear long-term view since most medications take 10-12 years to go from the laboratory to the medicine cabinet. Full FDA approval requires six months of data plus another six months for review before official approval is given. These additional steps then come at the end of the drug creation journey:

  1. 1.Research and laboratory work begins.
  2. 2.Preclinical research and animal testing looks into the drug’s safety for human beings.
  3. 3.Clinical research begins on humans, typically comparing test results from patients getting the therapy to those receiving a placebo.
  4. 4.The FDA reviews the data and then decides to approve or disallow the medicine.
  5. 5.The FDA monitors the drug for safety once it becomes publicly available.

The Covid-19 vaccines are examples of drugs required to combat a crisis, one that has already killed more than 606,000 U.S. citizens and 4 million people worldwide. They present different pharmaceutical marketing challenges than existing medications.

“An EUA can be given if there are no adequate or approved alternatives,” WKYC of Cleveland, Ohio states. Pharmaceutical manufacturing companies still need to prove the drug is safe by thoroughly testing against thousands of study participants.

“The only difference really between the emergency use and the licensure is that volunteers are observed for a longer period of time to see the duration of protection and if there might be rare adverse events that occurred down the road,” WKYC quotes Dr. William Schaffner of Vanderbilt University as saying.

Figure:

 Normal Drug Development Process

Difference Between EUA and Standard Approval

Drugs with full FDA approval have several major advantages over those with just an EUA, including:

  • The medications stay on the market after the pandemic is no longer an emergency
  • EUA-approved therapies must be pulled from the market
  • Medicines still in the development pipeline may be tested against newer, more drug-resistant, variants
  • The pharmaceutical manufacturer can market directly to consumers
  • After full approval, businesses can require all employees to be vaccinated, WKYC states

The FDA Requires Records

According to the FDA’s Code of Federal Regulations (CFR), Section 312.57

“Recordkeeping and Retention,” a drug sponsor (i.e., manufacturer), “shall maintain adequate records showing the receipt, shipment or other disposition of the investigational drug. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped and the date, quantity and batch or code mark of each shipment.”

Records must be kept for two years after the marketing application is approved or for two years after shipment and delivery of the drug for investigational use is discontinued and the FDA notified.

Traditional Recordkeeping is Cumbersome

Many pharmaceutical companies still use spreadsheets to keep track of records. However, they often get data from a single source or department. Multiple sources may mean mixed-up or missing records, slowing the approval process.

Typically, companies using older software tend to silo their data. Inventory has its records. Finance has its own. Sales and marketing have theirs.

The problem in terms of regulatory compliance is that none of this information is shared across departments.

Enterprise resource planning software (ERP) such as Microsoft Dynamics 365 Finance and Operations lets pharmaceutical manufacturers gather information from all of these different sources. The data is combined into one unified whole.

Dynamics 365 can then automatically generate labels. It allows companies to track everything from large batches to individual doses, making FDA compliance simple and easy.

Data comes into the ERP network from sources scattered literally all over the globe. Real-time information is available with the click of a mouse or typing a few keystrokes.

Dynamics 365 data is securely stored on Microsoft Cloud servers. It’s available any time, anywhere. Executives can obtain any record in the system quickly and easily, ensuring compliance with FDA regulations. This lets executives provide accurate data to regulators quickly and easily.

Summary

Covid-19’s death toll led the FDA to accelerate its approval process from 10-12 years to a mere matter of months. Moving forward, agile pharma go to market strategies that can adapt to these changing requirements will undoubtedly be more profitable. An effective ERP software solution such as Dynamics 365 helps pharma companies adapt, and be able to quickly provide any required regulatory documents in order to remain compliant.

Get a free consultation on pharmaceutical go to market strategy during challenging times.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Chemical Industry Pandemic affect

6 Challenges in the chemical industry due to COVID-19 and the future ahead

6 Challenges in the chemical industry due to COVID-19 and the future ahead 1920 1080 Xcelpros Team

At a Glance

  • As the world braces itself from COVID-19 recovery, decision-makers at significant chemical companies are looking for ways to realign their operational and manufacturing strategies to be able to sustain and grow.
  • Liquidity and capital resources impact the business, causing financial pain areas for the chemical industry.
  • The industry has also faced challenges due to disrupted global supply chains, labor shortage, dwindling demands for one industry and growing demands for others, and many more issues.
  • With the strategic overhaul, reinvention of smart factories, investment in automation, and other robust enterprise software, the chemical industry can turn the tide.

Like almost every other industry, the chemical industry encountered unplanned hassles in 2020 due to the Coronavirus global pandemic. Practically every department in chemical companies has experienced the ripple effects of a market slowdown. Things are still uncertain in terms of the supply chain’s stability, workforce capacity, changes in global trade regulations, etc.

Approximately 41% in the chemical industry are concerned about the effects of Covid-19 on workforce and reduction in production.
Approximately 23% are looking at disrupted supplies are a red flag.– Per a survey by PricewaterhouseCoopers

While global supply chain disruption has impacted businesses, the chemical industry can take advantage of certain factors like:

  • Increased demand for raw material required for hygiene products and sanitizers across the globe.
  • The drop in oil prices offering a chance to acquire oil-based raw material at a lower cost.
  • Dependence of many major and minor sectors on the raw material provided by the chemical industry.

There are also various strategic and operational changes that the decision-makers at chemical companies will need to help their companies sail through this crisis with minimal damage. The chemical industry also needs to prepare itself for the post-COVID era. However, before we get into plausible solutions, it is imperative to understand the challenges in chemical industry. Let us look at six major challenges that the chemical industry is dealing with due to the coronavirus crisis.

1.Liquidity and Investor IssuesThere was a sudden and steep decline in financial outcome in the first quarter of 2020 due to COVID-19. The market slowdown led to investment shortage, lower credit, etc. The financial impact has caused significant distress for the chemical industry, and top-level executives rethink their finance allocation policies to ride through these distressing times.

2.Shortage of Workforce and Reduced Production RateMany regions are still not back to normal and need to follow social distancing norms to avoid the coronavirus spread. The additional rules in place limit the ability of chemical production facilities to work at full capacity. Even the workforce that does not operate on the shop floor has to either work from home or stay absent. Current issues in the chemical industry lead to reduced productivity and lesser output from the production plants.

3.The Issue of Disrupted Supply ChainsWith the slowdown of all travel types (especially international air travel), there have been significant supply chain challenges in the chemical industry across the globe. The chemical industry is heavily dependent on different stakeholders working in harmony for seamless functioning. Businesses have taken a massive hit, and there are issues related to delays in obtaining raw material, delays in shipments, blocked consignments, and more.

Figure 1:Benefits of a Connected Ecosystem for Inventory Management

4.Discrepancies in the Demand of Raw MaterialChemical companies supply different raw materials to various industries, and they make arrangements for these stocks based on their orders, estimates, and market scenario. However, the lockdowns imposed due to the coronavirus pandemic caused many industries like automobile and consumer goods to cease their production. In contrast, other industries like hygiene goods, pharmaceuticals, and medical equipment manufacturing sectors had to ramp up their production capacity. An imbalance in the market caused discrepancies in the demand for raw materials, and the chemical companies have to realign their inventories to suit the changing needs. The market is recovering however still carries the effects of the pandemic.

5.Facilitating Social Distancing at SitesWorkers who are back to facilities require retooling to expedite work and play catch-up on customer orders that were previously halted. Many chemical companies have made drastic changes to their plants to provide a safe atmosphere for their workforce. This atmosphere involves regular sanitization of the premises, facilitation of social distancing, temperature checks of the staff, interatcion and collaboration through digital tools, etc.

6.Changes in Strategy for the Post-pandemic EraThe strategists and top executives at chemical companies have a robust and demanding job at their hands to realign their game plan for the post-pandemic era. Replanning involves gauging the market’s pulse at a granular level, understanding the varying needs for different chemical compounds, and providing investors and business partners with the plan’s visibility. Higher visibility drives the requirement to onboard agile analytical tools in conjunction with their manufacturing execution and warehouse management systems.

While there are many challenges in the chemical industry, they can get these issues addressed with comprehensive, all-inclusive technology. Companies need to evaluate a business solution that provides end-to-end Supply Chain Management, Financial Management functions plus embedded analytics to realign their processes and gain in depth visibility of the operations.

2020 has seen a massive shift in the overall functioning of chemical companies, which has enabled the need for proper planning, extensive use of robust integrated tools, and timely actions. By retooling to make themselves more agile, chemical companies can ride this storm out and progress forward. Ability to adapt to rapid changes in business is now one of the major OKRs within a Chemical company. Enterprises that wish to differentiate themselves in the Chemical industry need to transform from traditional to becoming new-age companies.

Key Takeaways

  • The chemical industry needs to be agile and flexible to gauge the changing needs and serve their best during these trying times.
  • The right digital tools help chemical companies to not just strategize but also effectively execute to grow.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

pharmaceutical industry challenges

Top 5 Challenges in the Pharmaceutical Industry: The COVID-19 Effect

Top 5 Challenges in the Pharmaceutical Industry: The COVID-19 Effect 1920 1080 Xcelpros Team

At a Glance

  • The economic upheaval caused by the shutdowns to prevent the spread of coronavirus is raging globally, and many industries, including the pharmaceutical sector is facing uncertainties.
  • The pharma companies, however, have another significant role in the pandemic, and that around managing Pharma operations during the pandemic.
  • The unprecedented demand and expectation from the pharma sector in terms of R&D, production, supply chain management, and cost optimization is presenting many issues across the industry.
  • Top executives and decision-makers will need to maneuver their pharma companies in a calculated manner to rise to humanity’s occasion and make their businesses steady again.

The rapid spread of the coronavirus across the globe halted air travel, crumbling healthcare systems, countries going under lockdowns, thousands losing their jobs, and a looming prospect of the economic crisis are all the events that we as a world have seen in 2020. Industries across the board face the brunt of disrupted supply chains, skeletal workforce, and dwindling investments. However, one industry to which everybody is looking with bated breaths is the pharmaceutical industry- for it can provide an answer to this pandemic in the form of a drug or a vaccine.

Figure 1:Adverse Effects of the Covid-19 Pandemic Globally

To say that major and minor pharma companies have sprung into action would be an understatement! The leaders and decision-makers from different pharma companies have responded reasonably quickly and are guiding the world towards a better tomorrow. However, the ‘new normal’ that we live in currently presents many pharmaceutical industry challenges (from financial to operational).

According to a report by Global Data, 23 percent from the pharmaceutical sector are concerned about supply and demand gaps tied to the COVID-19 outbreak.

Let us take a look at some of the top concerns that the pharmaceutical sector will be facing in the current times and the post-covid-19 world:

1.Disrupted Supply ChainOver the globe, supply chains have been broken, disrupted, and some have even come to a grinding halt because of the nation-wide lockdowns, closed borders, and halted air travel. The coronavirus pandemic has created a disorder of the kind that we have never witnessed before. The pharma sector drives its operations through the smooth running of the supply chain to deliver drugs and vaccines across the globe by:

  • rapid procurement of raw material and chemicals for drug manufacturing
  • managing equipment for research & production
  • optimized warehouse management
  • inventory management through track and trace
  • on time in full shipments to customers

The industry executives will need to reduce their pharmaceutical supply chain challenges by changing strategies and using available resources to their fullest. A robust supply chain management (SCM) tool with interconnectivity and interoperability can work wonders to realign the supply chain and provide extensive visibility to stakeholders that sequentially bring processes back on track for pharma companies.

2.Need for Highly Skilled Workforce Almost all the developed and many developing companies are involved in research, development, and clinical trials for the potential coronavirus vaccine. This research requires scientists with immense knowledge, experience, and skills. The pharma sector will need to boost its investment in the high-skill workforce to continue making progress in the current and future times.

3.Humongous Data Collation and AnalysisThe research and clinical trials for potential drug treatments and vaccines for coronavirus worldwide generate unprecedented amounts of data and information. Paramedical experts and scientists in the pharma industry look at agile tools to collate and manage data while generating insights. After all, the clinical trial data insights will help pharma companies guide the world towards a better tomorrow.

4.Need for Agility and TransparencyWith the Covid-19 pandemic, there has been immense interest in the pharma sector’s workings by almost all social hierarchies. There is an increased need for faster, accurate, and transparent operations across the board.

5.Workforce optimization and ControlsDuring COVID-19, Pharma manufacturing companies made many adjustments to modus operandi. That includes accommodating remote workforce, social distancing when in person, wearing masks and gloves, and avoiding any possibility of spreading the coronavirus. Mainly while dealing with organic material within the raw material ingredients, additional testing is needed before the drug passes Quality and is deemed ‘in spec’. The extra impetus has led to newer Standard Operating Procedures in operations and quality when it involves batch production through batch records.

While these changes and concerns are bound to affect the pharmaceutical industry’s workings, proper management, technology, and software to navigate these challenging times will enable the pharmaceutical sector to rise to the occasion.

The Covid-19 pandemic has brought forward existing and new challenges for the pharma sector. However, it has given a chance to create opportunities and get transformations that can have a positive impact on the pharmaceutical industry.

Key Takeaways

  • Pharmaceutical companies need to change their business strategies to suit the current environment and to navigate smoothly through the times of the Covid-19 pandemic.
  • There is a need for pharma companies to invest in robust software and tools that can optimize supply chains, facilitate automation, reduce manual labor, and systematically manage the enterprise to maximize their output.

For more information on our Microsoft offerings for the Pharmaceutical industry, Contact us today!

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Current biotechnology issues

Top Concerns of Biotechnology Industry Current Issues

Top Concerns of Biotechnology Industry Current Issues 1920 1080 Xcelpros Team

At a Glance

  • The world has turned its hopes towards biotech companies to reduce the spread and impact of the Covid-19 pandemic.
  • The biotech industry is working continuously towards fortifying healthcare systems, enabling serosurveillance to gauge the spread of disease in a community and to aid in the development of a vaccine.
  • With governments across the globe funding research and production costs to enable biotech companies to win this battle against time, there are various operational, technological, and workforce concerns that these companies face that need to be addressed with strategic maneuvering from the apex.

Introduction

The Biotech and Life Sciences industry is one of the most sought after sectors this year in conjunction with the pharmaceutical industry as a solution to the current Covid-19 pandemic. Health experts across the globe have agreed that highly effective treatments, including the development of a vaccine, would be needed to reduce and eventually stop the spread of novel coronavirus, allowing cultures around the world to get back to normal activity. While some countries have fared better than others in handling the Covid-19 health crisis, there are still looming fears of new waves. Current Biotechnology issues are expected to normalize with an effective antidote or vaccine.

While the biotech industry sprung into action to begin developing a solution almost immediately, there’s still a long way to go. Challenges faced by biotechnology have been as real as the crisis itself. While the biotech and life sciences industry has a primary role in addressing pandemics like that of COVID-19, it’s not immune to economic downturns, supply chain disruptions, workforce shortage, or any other challenges.

Below are some of the pain points that the Biotech and Life Sciences industry are facing:

01.Roadblocks and Hurdles

All over the world, various biopharma companies, both privately and through government-funded efforts, are performing clinical trials for different potential vaccines and drugs. In 63 days after the genome sequence of the novel coronavirus was shared with the world, USA’s Moderna Biotech Inc. had developed its mRNA candidate to battle the pandemic. Being able to move at a pace never seen before requires immense talent, robust AI-enabled software setup to perform bioinformatics processes, and exceptional R&D infrastructure.

The journey from vaccine development to approval and administration on a global scale is wrought with numerous additional steps and hurdles, requiring mobilization of assets and task forces, recruitment of volunteers, conducting clinical trials, collation, and analysis of humongous amounts of data, smoothly operating supply chains, enormous monetary investments, and a well-equipped production and distribution infrastructure.

02.Collateral Delays

The spread of the coronavirus pandemic brought most of the world to a screeching halt, with many businesses having been forced to close. A result of this is disruptions to major clinical trials and research work on drugs and vaccines for other life-threatening diseases like cancer, HIV, autoimmune diseases, etc. These are collateral delays, and the biotech industry is now challenged with not ignoring existing health issues while still focusing on developing a solution for the ongoing pandemic.

03.Global Distribution

Health experts and top executives at significant biotech companies agree that even if we succeed in making an effective vaccine for Covid-19, there would be a need for immense strategic and operational changes in the current global and local supply chains to ensure that it’s produced and distributed to everyone around the world. With disruptions to most supply chains, only adding to challenges faced by the Biotechnology industry, it will be interesting to see how these organizations address these issues.

Figure 1Covid-19 Vaccine Development in Phases: The Role of Biotech and Pharma

04.ROI

A global health crisis of this scale requires a humanitarian approach to ensuring treatment is available to all. This is why most pharmaceutical and biotech companies have agreed that the first or even second batches of any drugs or vaccines they produce(should they prove to be valid) will be distributed at non-profitable rates. We shouldn’t, however, neglect the current biotechnology issues who are investing millions of dollars in rising to the occasion. These organizations will need a blueprint for steady business growth and monetary returns in the post-COVID era.

05.Remote Solutions

Now more than ever, biotech companies need highly skilled and experienced scientists, health experts, and paramedical personnel who can make this journey towards vaccine development smooth. With most businesses still not fully operational to support new workplace requirements, more remote access solutions will have to be developed and embraced to keep operations moving forward.

Role of Microsoft Dynamics 365 Supply Chain in Biotech Companies

We have spoken about some ongoing challenges faced by the biotechnology industry in the war against Covid-19. It is important to note that current biotechnology issues are handled with strategic realignment and robust Enterprise Resource Planning tools. An ERP system such as Microsoft Dynamics 365 Supply Chain enables biotech companies of all sizes to optimize their supply chains, mitigate costs on manual labor, avoid redundant efforts, automate billing cycles, and other enterprise-level processes.

Key Takeaways

These are challenging times for organizations in the Biotech and Life Sciences industry. They now, more than any other sector, continue to work at unprecedented speeds to help the world end this global crisis. Billions of lives are at stake, waiting anxiously for a solution to the ongoing pandemic. There are many challenges that the biotech sector needs to address from disrupted supply chains to the need for multi-layered coordination for clinical trials. With strategic intervention by strong leadership and the use of modern robust tools, these challenges and more, can all be overcome.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Enhance Supply Chain Planning within Pharmaceutical operations

Enhance Supply Chain Planning within Pharmaceutical operations 1600 1000 Xcelpros Team

Introduction

The COVID-19 pandemic has created significant changes in market dynamics, forever changing the face of the global economy. Along with the pandemic’s impact on our daily lives, there has been a ripple effect in the day-to-day operations of Pharmaceutical manufacturing. As industries around the world continue to adjust to changes, Pharmaceutical manufacturers in specific, are noticing technology, process, and infrastructure gaps that are impeding growth and sustainability. Additionally, businesses that were forced to slowdown production during the initial stages of COVID-19 and are now getting back to full momentum, are finding it difficult to manage end-to-end operations.

Pharmaceutical companies cater to a customer base that is dependent on their products to manage patient health. This requires additional efficiency in everything they do, especially for planning supply-demand. The primary objective is to not halt manufacturing, as the dependencies can impact the entire Pharma value chain. Since pharma companies are quality controlled, there is an additional time factor that comes into the picture while determining the right deadlines to produce finished product and deliver to end customers. The entire process from drug discovery to packaging for delivery is a series of collaborations within the supply chain before the final product reaches the end customer.

Roughly 66% of the surveyed were concerned that COVID-19 could result in a possible supply chain disruption for pharmaceutical products. The statistic illustrates concern levels on possible drug supply chain disruptions due to the COVID-19 pandemic as of April 7, 2020. Matej Mikulic | Statista

The Planner’s Panorama

Due to the rapid changes in the global supply chains, production planners at pharmaceutical manufacturing are now tasked with surveying inventory and operations with a new set of eyes. Organizations need to be more watchful of new safety standards related to inventory storage, retrieval, usage of material, and equipment maintenance. Tools like Visual Gantt Charts are becoming invaluable for planning and managing inventory. The ability to depict a weekly schedule of operations for different production jobs and a clear picture of resource capacity is a core requirement for any good production planner. The production planner’s prime focus is to ensure there are enough raw materials and resources (equipment or human resources) to ensure a near-to-perfect supply-demand ratio. An additional element that supports a planner is to have inventory visibility within their current warehouse and plan transfers of inventory from overflow warehouses.

Simple visual planning methods are no longer adequate to correctly manage all inventory-supply-demand processes and ensure proper movement of transactions across the company’s supply chain.

What planners need is a robust system that can track supply – demand by including a complex set of parameters such as lead times, working calendars, the capacity of equipment and capability of vendors to ship materials on a timely manner. Planners also need the ability to alert different departments of the next steps based on plans made for upcoming weeks or months. Any modern system should be able to offer required insights including the current state of batches manufactured and available equipment for future work orders.

A production planner often prefers handling the supply chain proactively rather than reactively by responding to the demands. The planner needs visibility of when the finished product will be ready, tested, and released for shipment. This type of planning helps overcome downtime and shortages in raw materials, which is a common issue in most companies. Responding quickly to changing inventory is one way for planners to be more proactive.

Even today, many small and medium-sized pharmaceutical companies continue to use a combination of excel sheets, inventory reports, and some old school methods when managing their supply chain. As industries continue to face changes related to the COVID-19 pandemic, only companies that have thought ahead and have invested in an automated AI-based planning system that can assess and predict future demand as well projected resource plans will be best equipped to handle their product delivery on time and in full. Companies now need a quicker and more streamlined process to take their products to market.

The Role of a Master Planning and Scheduling System

01. MPS Driven by Demand

The goal of a Master Planning and Scheduling (MPS) system is to provide suggestions to meet material requirements. If set up correctly, MPS systems respond to demand and plan supply accordingly. Demand usually comes from sales orders recorded in the Order Management system. Master planning ties Planned orders for Production or Procurement to corresponding sales orders. The supply requirements are then calculated based on settings for each item that is included in the Finished Goods Bill Of Material(BOM). The coverage settings of an item show precisely how and when to send feedback with a view of current stock levels or foreseen changes in stock levels from existing planned orders in place.

02. Planned Supply

MPS systems use algorithms for tracking the demand from sales orders, customer forecasts, safety stock levels, and calculating net-requirements for purchase and manufacturing. MPS also pulls together independent or groups of demands that trace back to the production of intermediate and raw materials to be consumed in different Manufacturing and Packout processes.

Determining the quantities required would depend on the inventory quantity setup of any single item. The requirement could be specific for a static batch size or dynamic quantities based on the demand needs. MPS systems provide planners the capability to either consolidate supplies across multiple demand orders, offering a comprehensive supply and demand management experience, or consider only the net change from the start of a full production run.

03. Lead Times

The ability to define lead times is critical to a master scheduling system. For instance, if a user enters a purchase lead time the system should account for the time it takes to receive raw materials after placing a purchase order.

I. Purchase Lead Times

Purchase lead times for a supplier can be set up based on different factors including

  • Pricing agreements
  • Time in days that a supplier can accommodate
  • Transportation time, and
  • Any other unforeseen coverage settings

Within Dynamics 365 Finance and Supply Chain, a purchase lead time found for a specific supplier and item combinations takes precedence over general settings of an item. This applies when (1) no vendor is assigned to the item, and (2) the Find trade agreements checkbox is selected via Master planning parameters form > Planned orders tab.

II. Production Lead Times

Production lead times are the details that can be configured in coverage settings; however, these values are disregarded when items are produced via routes. Routes, defined in the modern Production control modules, consider available resources (people or equipment) and their working schedule. In this situation, production lead times needed to create finished goods do not have to be specified by a user, as they are calculated automatically.

Planning for the Unknown

There are still unknowns within pharmaceutical production and operations. Without the right system, planners will struggle to retrieve the data needed to better streamline the manufacturing process. To help with this, Production Planners can benefit from valuable information like –

  • Batch production history and patterns of user behavior that show actual production lead times
  • Quality standards of work-in-process production run based on raw materials that are procured from specific suppliers
  • Quantity yields of past batches, actual scrap percentages based on changes in production routes and resources
  • Accurate actual batch costings in comparison with estimates

These additional details provide supplementary insights to help improve production, downtime planning, maintenance, and most importantly, promise dates to customers. Production planners need to be equipped with a system that presents elaborate sets of insights and actionable suggestions on how to plan/schedule production operations. A well reliable tool empowers a company to drive efficiency and growth.

An AI-ML & Analytics Centric Approach

Eventually, and soon, a standard planning system will no longer be capable for the Pharmaceutical supply chain to operate efficiently. Systems that reduce human effort, learn from history, and improve daily operations will become necessary to overcome inefficiencies. At the same time reporting possible issues and roadblocks that impact orders as well as deliveries, improves the overall plan vs actual picture. Production planners are proving to be more efficient when they have real-time and historical analytics available during the planning process to make better decisions while managing inventory and orders. A guided method of operating and reporting through actionable data can make your company a powerhouse within the industry. An intelligent and optimized planning system can help eliminate guesswork for the production planners in build a competitive edge in the market.

Final Thoughts

The supply chain within a pharmaceutical company is only as efficient as the ability of a planner to proactively coordinate supply, demand, and inventory. A robust planning system with an emphasis on analytics and guided user behavior can play a key role in building efficiency and moving shipments out the door, along with meeting the required quality standards.

Xcelpros has designed Microsoft’s offerings to enhance planning for Pharmaceutical, Chemical, or Biotech industries. For more information on Production planning and Scheduling tools within Microsoft – Contact us!

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Maintaining an Integrated Supply Chain: Key Solutions

Maintaining an Integrated Supply Chain: Key Solutions 1280 720 Xcelpros Team

At a Glance

  • Many organizations that fail to recognize supply chain as a strategic business function, tend to not move to a digital supply chain and lose out on the benefits that come with the transformation.
  • Traditionally, manufacturing companies have treated supply chain as a transactional function, a bargaining chip to reduce price and secure on-time delivery of raw materials. The modern supply chain is viewed as a strategic asset to the organization, integrated deeply with other business functions, aimed to increase customer satisfaction.
  • Companies unable to track hidden costs across the supply chain lose track of actual costs, damaging their bottom line. Proper supply chain monitoring can save anywhere from 20-30% of distribution costs.

The Supply Chain Challenge

Supply chain management is one of the most critical elements of success for any business in today’s global market. However, its application is undermined by many companies as business leaders face challenges to control the cost of a supply chain without compromising on its efficiency. Since COVID-19 we have witnessed drastic changes in methods and methodologies for streamlining supply chain operations. It, however, doesn’t take away some key fundamentals required for healthy functioning of a company’s supply chain and inventory management.

According to the Logistics Bureau, for companies running global operations, their supply chain cost could rise as high as 90% of their total expenditure.

The Supply Chain Slowdown

The problem lies in poor strategic management. Supply chain managers are focusing on cost minimization, most of them without having detailed field knowledge of how the system works, and the result is it is impacting other areas of the process such as inventory optimization, ‘on-time delivery in full (OTDIF)’ and customer satisfaction. Trying to improve one KPI is resulting in a cost spike in other areas of operations, which can have a long-term impact on revenue.

FIGURE 1 Where Business Leaders are Falling Short

A robust supply chain needs strategic alignment and planning in line with the overall business functioning. For example, in order to control cost, you need to first understand the key drivers of cost in the supply chain and most importantly how to measure the supply chain cost. While the strategy is important, establishing an integrated supply chain requires a synchronized approach to planning, execution, and application of technologies in order to create an end-to-end unified system across the entire organization.

FIGURE 2 Key Elements of an Integrated Supply Chain

In this article, we will touch upon some interesting facts that make an appealing case as to why the Supply Chain strategy needs to be digitally enhanced and properly integrated with other parts of the business.

Switching from Traditional to Next-Gen Digital Supply Chain

The rapidly evolving business landscape is disrupting the way companies function. Moreover, the advent of the latest technologies and growing competitive markets are driving companies to push their limits and redefine supply chain operations.

Is your business ready to embrace a digital supply chain as a key distinguishing factor for its competitive advantage?

Most SMBs are holding back the transformation due to the fear of possible risks that could surface. Per our industry experience, it’s due to the age-old perspective in which company leadership is analyzing their supply chain. In most of the cases, we found that they are way behind the entire purview and don’t realize the true potential of a well-integrated, technologically advanced supply chain.

Traditionally, business leaders focused on pricing and product quality, but priorities today have completely shifted. Major Objectives and Key results of organizations are geared towards optimized supply chain and operations to boost businesses forward. With Industry 4.0, advanced analytics, and robotic process automation rising, companies are realizing the need for an integrated supply chain. This has become even more true as the Covid-19 crisis continues. Demand planning and fulfillment, supplier-customer relationship, customer retention, on-time delivery are some of the major expenses of a company. An efficient supply chain not only helps with cost reduction in these segments but also ensures growth, profitability, and customer satisfaction.

Top Reasons to Upgrade Your Operations with a Next-Gen Digital Supply Chain:

Shifting from a plant-level production planning to a demand-driven focus with customer-centric mindset but not compromising with the product quality

Getting rid of outdated processes and technology to match the transforming global business landscape

Reducing cost to formulate a more efficient value chain to remain cost-competitive in the market

Ability to outsource parts of your supply chain process in order to reap economic benefits and superior supply chain network design

Achieving more efficient product lifecycle management

Collaboration with stakeholders to integrate business processes for increasing visibility throughout the value chain

The Impact of Supply Chains

An integrated supply chain influences the overall functioning and improves profitability of the business. Going digital and increasing interoperability across these functions sets a business up to accelerated growth. Let us discuss a couple of key areas that are impacted by a well designed supply chain.

FIGURE 3 Upgrading the supply chain will improve your bottom line

01. Supply Chain and its Impact on Customer-Centricity

When business leaders discuss improving their supply chain, their main focus is usually related to accelerating growth by cutting down costs, achieving better lead time, and ensuring on-time delivery; as all these factors contribute towards business development. What slips from their mind is what customers really care about. It all starts and ends with customer satisfaction. Delivering the right product at the right time improves your organization’s brand value and credibility to customers.

What the customer cares about is receiving quality products on the promised delivery date without having to spend too much time or effort. This can be seen in Amazon’s announcement of one-day delivery. Late and inaccurate deliveries bear a significant impact on customer loyalty.

70%

of industry professionals predict that their supply chain is going to be a key driver of improved customer satisfaction by the end of the year.

Source: Accenture

Your procurement division must understand the importance of cost-saving, but they need to be in line with the expectations of the customers and procure quality raw material for manufacturing the items. If expectations on raw material quality is not set, you could save money purchasing raw materials upfront, but end up spending more in the long run.

Let’s take a look at Kimberly-Clark’s journey to understand this better:

Kimberly-Clark is a manufacturing-focused organization that up to a few years ago did not have a supply chain division. Sandra MacQuillan, their first Supply Chain Officer, built a solid team to ensure the supply chain was focused on customer satisfaction. In the process, she integrated various functions such as procurement, quality (know more on quality management by clicking here), logistics, manufacturing, safety, etc. that are interconnected and delivered for one common goal – that is customer satisfaction.

Kimberly-Clark was able to achieve 25-30% cost savings by interconnecting various aspects of the Supply Chain, focused on better customer service, resulting in improved efficiency.

If you connect with the issues faced by Kimberly-Clark, or your supply chain is functioning in silos, it could be the best time to make a change. You can take this opportunity to update and integrate your supply chain with overall business functions and work towards a common goal like customer Satisfaction. A strongly integrated application will have the ability to incorporate holistic business functions including analytics, collaboration with notification, secure information sharing, control-based decision making using Artificial Intelligence, and more.

FIGURE 4 KPIs that are critical for supply chain monitoring

02. The Role of supply chain in sustaining business long term

According to the Logistics Bureau, nearly 50% of companies shut down within the first five years of operation. One critical factor contributing to these failures is an inefficient and poorly conceived supply chain. Supply chains in most organizations have evolved as a practice, rather than a well-designed process.

79%

of companies with robust and high-performing supply chains are able to outperform their average peers in terms of higher revenue growth. This fact signifies the positive implication of a connected supply chain for a business.

Source: Deloitte

5 Steps to Integrate your Supply Chain

Break down organizational silos

For an effective, integrated approach to Supply Chain Management (SCM) the organization must operate end-to-end as a unified entity.

01

Define organizational objectives

Move beyond basic business and functional unit design and metrics. Look at the organization holistically and define the objectives as a complete entity.

02

Align business processes

Take a cross-functional approach to business process design. Start at a high level and map out the supply-chain flow with the goal of creating an end-to-end mapping of the business process.

03

Design the IT architecture to support an integrated approach

Leverage a cross-functional approach to IT systems design. As much as possible, standardize the organization in terms of the applications that are used. Seek to eliminate as many disparate applications as possible in favor of a common set of applications across the business.

04

Reshape leadership and culture

For most organizations, the major roadblock in delivering an integrated approach to supply-chain management is culture change. Change of this magnitude must be driven by solid leadership. There should be strong collaboration to drive the effort to deliver an integrated supply-chain organization.

05

Final Thoughts

There is no way the importance of an integrated Supply Chain should be overstated or undermined. If you or your organization have not prioritized your supply chain efforts, it’s never too late to take the first step.

An intelligent ERP software comes with a holistic supply chain module along with advanced analytics to support the following functionality.

  • A manufacturing execution system
  • Financial and cost accounting
  • Inventory and warehouse management
  • Purchasing and planning of materials
  • Product information management
  • Sales and marketing of the products
  • Transportation and logistics management

In order to push a company forward especially post-COVID-19, a sound digital supply chain strategy would be needed.

Do not let operational inefficiencies limit your business, long-term goals

Act Now

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com