PHARMACEUTICAL

pharmaceutical serialization track and trace

Gen-Next Serialization in the Pharmaceutical Supply Chain: Improving Track & Trace

Gen-Next Serialization in the Pharmaceutical Supply Chain: Improving Track & Trace 1500 1049 Xcelpros Team

At a Glance

  • Worldwide, pharmaceutical companies are dealing with drug counterfeiting, adulterations, supply chain thefts, and packaging glitches. Serialization has become the need of the hour, and it is much more than just applying barcodes to personalized medicines.
  • This age of fast-paced digitization calls for modifications and improvements in the serialization techniques. To better strengthen the supply chain loopholes need to be identified and transparency to be maintained not just at the batch level, but for each strip or bottle of the drug.
  • Pharmaceutical companies and their supply chain vendors will need to make use of Advanced Analytics, Cloud, and Internet of Things (IoT) to get a grip on the modern-day serialization techniques.

Traceability being a mandate globally, and the laws changing across borders, major pharmaceutical companies are working towards improving the tracking and tracing process in the supply chain for better compliance. To that effect, pharmaceutical companies are developing and implementing serialization techniques. Supply chain security, counterfeiting drug theft, better product traceability, mitigation of drug contaminations, and overall cost-savings are different facets that are considered.

Reports suggest that by 2023, globally, more than 90% of drug supply will be scrutinized under track and trace regulations to enhance patient safety measures by combating drug counterfeiting.

The need for serialization is no longer restricted to global mandates compliance but accounted for various other factors. Over the years, pharmaceutical companies have struggled to maintain transparency, accountability, and integrity in the supply chain. The product lifecycle from manufacturer to supplier, distributor, and ultimately the consumer has had various loopholes at different levels – package damage, drug theft, manual errors, and so on. To seal these gaps and improve overall supply chain, serialization is proving to be a useful technique even surpassing the shortcomings of other solutions such as sturdy packaging and traceable 3D hologram models.

FIGURE 1: Common Loopholes in the Pharmaceutical Supply Chain

 

Innovation is the key to improving trace and track in any supply chain model, and the pharmaceutical supply chain is no exception to this. Companies worldwide are investing millions of dollars in maintaining the integrity of their product throughout its lifecycle from the lab to the patient. To overcome manipulation in product quality and quantity, assigning either a unique identification number or a barcode to the individual items (such as a strip of tablets of a bottle of medicine) for computerized serialization and tracking proves to be a fortified supply chain solution.

This article discusses the newer innovations and latest trends in serialization in the pharmaceutical supply chain.

01.Data Encryption and Data Security

The primary aim of pharmaceutical supply chain serialization is to make sure that the ultimate consumer gets the right drug at the right price. At the same time, companies can easily trace and track their products. This calls for stringent data management and security. The inefficiencies are arising in life sciences companies’ supply chain due to data errors or data leakage causing massive financial debt.

According to Interactive Data Corporation (IDC), the pharmaceutical industry loses on average 4.5% of its potential revenue because of supply chain inefficiencies.

The upcoming trend in serialization will place extra emphasis on data encryption to maintain security and thus the integrity of the product throughout its lifecycle.

02.Recalling Made Possible for Individual Product

The pharmaceutical industry is highly susceptible to product recalls in cases of insufficient packaging or a risk-inducing drug. Earlier, these recalls were made at batch-levels, causing companies massive revenue leakage and disturbing the supply chain on a larger scale. Narrowing down traceability to the individual unit makes it possible for companies to in-turn, narrow down the recalls to different products. Serialization also allows in knowing exactly when and where the product quality was compromised.

FIGURE 2: Serialization to Improve Track and Trace

 

03.Use of Advanced Analytics

The life sciences companies and their collaborative research branches are looking to better gauge the consumer pattern to cater better to the demands. The use of advanced analytics applications like Microsoft Power BI for visualized, cutting-edge business intelligence reports for serialization will help in learning this pattern. Power BI can enable the end-users in creating their customized dashboards, thus helping with predictive analysis. This can also help in preempting the demand for a particular drug so that pharmaceutical manufacturers can alter their supply chain accordingly to meet the requirements.

04.Enhanced Visibility at Every Level of Pharmaceutical Supply Chain

Apart from ensuring better accountability and compliance, companies are also making use of serialization to enhance visibility and improve monitoring at every level of the pharmaceutical supply chain. This will aid in avoiding stock-outs, monitoring packaging, improving the distribution process, and making sure that the drug is supplied per requirement across the market.

05.Barcoding & Labeling

This time-tested method is one of the most-used for a reason- it makes serialization a lot more streamlined and can help in advanced tracking. The latest digital barcoding techniques and advanced label-making capabilities can help the pharmaceutical industry in taking serialization in the supply chain, a level up.

10%

of the global pharma drug supply is counterfeit, which costs up to $200 billion annually. Additionally, the Interpol calculation reveals that this volume of counterfeit drugs takes a toll of 1 million people every year.

Source: WHO

How will Serialization Impact the Face of Pharmaceutical Companies in the Near Future?

  • Globally various countries like the USA, UK, Italy, Turkey, and India have taken up serialization of their pharmaceutical supply chain to some extent or the other. Speaking specifically of the United States, serialization of all the drugs at the sealable unit and case level has become a mandate since November of 2017 under the Drug Supply Chain Security Act (DSCSA). This will impact the pharmaceutical companies and their supply chain vendors in the following ways:
  • In the near future, manufacturers will need to serialize all their drugs at an individual level with barcodes for better track and trace.
  • There will also be a change in the ways in which manufacturers supply their drugs. Thanks to serialization, they will get better visibility of the market, down to individual drug demand. This will help in better drug distribution.
  • Warehouses and inventories will be equipped with better visibility and a fortified drug distribution plan.
  • There will be a better understanding and communication among cross-functional teams. As serialization has an inflow and outflow of information at the production-floor level and at inventory-level, life sciences researchers, packaging personnel, IT experts, and distributors will all be on the same page with regards to the data available for a particular drug.

Challenges in Serialization Faced by Pharmaceutical Companies

Like any other change across the supply chain, serialization has its own set of challenges for the pharmaceutical companies. Here is a look into some of the potential challenging areas when it comes to implementing serialization:

  • Hardware Setup and Updates: Companies will need to make sure they have highly functioning hardware to manufacture labels, barcodes, and seals that are essential for serialization.
  • Steady Flow of the Production Line: Sticking to the process of serialization and making your skill base acquainted with this process might slow down the production line. The use of labels for individual units will also significantly slow down the packaging process.
  • Overall Cost Inflation: Cost inflation is a given when it comes to serialization, given the costs involved in hardware and software. However, this can be negated via pooled-investments and sustainable applications of the hardware and software.
  • Skilled Personnel Shortage: Newer, digitized ways of serialization would require a skill base that is well acquainted with the technicalities and details of these techniques. Currently, companies are facing a lack of a skilled employee base that is technically sound enough to implement their serialization strategies seamlessly.
  • Technical Glitches: Serialization is a process that requires minimal human intervention, and while that can be beneficial to avoid manual error, there is also a possibility of technical glitches in the process leading to incorrect tagging and compromised track and trace.

Key Benefits of Serialization Implementation in Operations:

  • End-to-end implementation across the supply chain for drugs in a hassle-free way
  • Seamlessly sealing the supply chain loopholes to combat drug counterfeiting and warehouse packaging glitches
  • Minimal human intervention needed, making serialization a full-proof, effective way to ensure brand authenticity and mitigate batch recalls
  • Total compliance with the US traceability regulation.

With all the challenges and benefits in mind, every pharmaceutical company will need to keep working towards an advanced, digitally-adept, full-proof serialization process for their supply chain to counterfeit the proliferation of drugs and avoid compromising with drug quality.

Key Takeaways

  • Serialization in pharmaceutical supply chain plays a significant role in avoiding drug theft, counterfeiting, batch recall and plausible hazard to the patient’s health; Newer trends in serialization are making use of advanced analytics for better drug distribution and fewer stock-outs.
  • No two pharmaceutical companies will have the same blueprint for their supply chain, and thus they will need to devise unique serialization processes to suit their requirements.
  • As the serialization of drugs has become a mandate in the USA, it is imperative for pharmaceutical companies and their supply chain vendors to understand and master the technical details of implementing serialization at batch and case levels.
  • The pharmaceutical companies will need to prepare themselves to overcome the potential challenges in implementing adept serialization to fortify their supply chain and enhance visibility for better drug track and trace.

XcelPros’ Microsoft Dynamics 365 solutions enable pharmaceutical companies to seamlessly implement serialization for better compliance and enhanced track and trace.

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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

Pharmacovigilance Importance

The Importance of Pharmacovigilance During a Pandemic

The Importance of Pharmacovigilance During a Pandemic 1440 810 Xcelpros Team

At a Glance

  • The World Health Organization (WHO) has always emphasized providing the most effective drug that does not cause severe adverse effects.
  • An understanding of adverse effects and how to prevent them by assessing the right chemicals, quantities, and processes in drug/ vaccine manufacturing is a must.
  • There are several digital solutions and services available today designed to help the top scientists and decision-makers in the pharma companies in their pharmacovigilance journey.
  • Both now and after the Covid-19 pandemic, organizations worldwide will need to place significantly more focus on drug quality checks to avoid any mistakes caused by rushing the process as we return to ‘normal’.

Today, terms like ‘clinical trials,’ ‘safety assessment tests for vaccines,’ and ‘FDA approvals’ are trending due to COVID 19. While these terms have always been a part of any pharma and biotech manufacturing companies’ pharmacovigilance protocol, the pandemic at hand has brought them light. Most of us are curious about why it takes so long for a drug or vaccine to get approved for mass use, and rightfully so. The answer lies in the principles of pharmacovigilance.

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.

The Primary Goals of Pharmacovigilance Guidelines

  • Assessing short term and long term adverse effects of a drug
  • Continuously collate and monitor the safety-related data of a particular drug
  • Perform risk v/s benefit assessment of the drug to make a guided decision on the administration of the drug
  • Two-way communication of the data about any Adverse Drug Reaction (ARD) between health professionals and clinical researchers to maintain transparency at all levels
  • Intervention by medical bodies/ pharma companies whenever required to prevent an unsafe drug’s distribution and administration

Pharmaceutical companies require a team of professionals to carry on this constant quality check journey for their drugs. This team can consist of scientists, clinicians, biochemists, physicians, and medical writers. Their job is to collect, collate, analyze, and assess every drug’s safety profile data. However, for a task that requires constant alertness and an unprecedented level of agility for accurate and quick response, manual applications are no longer enough. Pharmacovigilance plays an important role for pharma and biotech companies to use it as a solution. This solution should be smart enough to aid in centralized data collection, analysis, and run AI-based programs for drug composition analysis, safety profile mapping, and other crucial steps required for quality checks.

Pharmaceutical companies need to follow a wide range of processes to ensure their pharmacovigilance is up to standards. Any negligence or oversight can lead to severe fines, injuries, or even death.

According to a paper by Elizabeth Ndichu, MD, and Kevin Schulman, MD, The scope of the problem of poor-quality drugs transcends national borders because the manufacturing and supply chain of medical products thrives in an international market.

To comply with the quality standards and still meet the demands of fast-track drug development and clinical trials (especially in the times of a global pandemic), pharmaceutical and biotechnology firms need to strictly adhere to the process for end-to-end pharmacovigilance, which can include, but not limited to:

  • Carrying out detailed patient surveys for different age groups, geographies and of varying health conditions
  • Appointing pharmacovigilance consultants and experts (either in-house or third-party) to manage the intricacies of this journey competently
  • Making use of extensive databases to support technological platform such as Microsoft Dynamics 365 for the pharmaceutical industry to ensure error-free data maintenance and analysis along with report generation
  • Keeping all the stakeholders in loop at all times to avoid any oversight
  • Maintaining records of different pharmacovigilance solutions, especially products other than medicines such as cosmetic goods, nutritional supplements, and dietary products
  • Formulating a plan for intervention, mitigation, assessment, and resolution in the event of drug quality issues

Figure 1:Digital Ecosystem: Pharmacovigilance

Pharmaceutical companies will also need to be nimble in their approach towards pharmacovigilance. Leveraging technology for streamlining safety procedures and quality checks is not a matter of convenience, but an absolute necessity.

Solutions like Microsoft Dynamics 365 Finance and Supply chain provide Quality Control functionality and a way to enter, track, and report quality test results. This makes it easy to leverage technology to streamline quality check operations.

Using these solutions can pave the way towards regulatory compliance, stringent component mapping, and monitoring of a drug’s safety profile and reduce manual intervention for pharma personnel, allowing individual case safety reports (ICSRs) to be performed with ease. Microsoft Dynamics 365 is a comprehensive solution that forms an ecosystem for all stakeholders involved by mapping a drug’s safety profile with intervening bodies.

Different departments can use these systems, clinical researchers, scientists, medical writers, physicians, medical representatives, state-owned drug governing bodies, and more, and are usually considered one of the best investments a company can make today.

Key Takeaways

  • Technologically-enhanced pharmacovigilance is the need of the hour for pharmaceutical companies.
  • Globally, the pharma sector is transforming, and this needs collation of medicinal data at a global level to map drug safety across geographies.
  • Forming a blueprint to follow the pharmacological journey is imperative for any pharma and biotech company.

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

Managing label serialization

How a Pharma CDMO can manage the Serialization Challenge

How a Pharma CDMO can manage the Serialization Challenge 1920 1080 Xcelpros Team

At a Glance

  • Today, serialization has moved past the point of being a nice-to-have option to becoming a necessity.
  • Pharmaceutical companies are tying up with CDMOs to develop sustainable serialization solutions for maintaining drug quality and avoiding supply chain glitches.
  • CDMOs face various challenges when it comes to implementing a robust serialization mechanism to allow for better distribution.

The advancement of Industry 4.0 and digitization has introduced another level of complexity when it comes to pharmaceutical serialization track and trace in the supply chain. The industry is constantly looking to improve its tracking systems while devising new ways to mitigate genuine concerns like counterfeiting, theft, packaging and storage mishaps, and drug adulterations. Pharmaceutical companies have long been outsourcing to CDMOs for the purpose of better manufacturing practices, and serialization of the supply chain is an imperative part of the process.

30-40%of all medicines circulated in the developing countries are counterfeit.

5-7%of all medicines circulated in the developed countries are falsified.

Source: WHO Report

These statistics pose a serious threat to the public’s health and challenges the authenticity of the pharmaceutical industry on a global scale. CDMOs worldwide face challenges either when implementing a robust pharma serialization solution or attempting to streamline manufacturing and distribution processes while understanding the unique serialization requirements of their clients.

Below are some of the challenges a CDMO faces while implementing pharmaceutical serialization track and trace and some interesting ways they can be addressed.

Serialization Challenges Faced by CDMO

  • Seamless Serialization for Multiple Clients
    CDMOs typically prefer to operate at a global level, providing comprehensive drug manufacturing and supply services to various pharmaceutical companies. Catering to a diverse base of clients has its own unique set of challenges, especially when it comes to the serialization of individual drugs. CDMOs need to equip themselves with the right technology to be able to modify their production or manufacturing lines in order to seamlessly serialize multiple drugs from or for different clients all at the same time.
  • Compliance Across Various Regions
    Within the United States of America, every state has different laws and rules in place, and across these states, many US-based pharmaceutical companies export their drugs to other countries. This can require a powerful pharma serialization mechanism in order to remain in compliance with varying global and local standards, rules, and regulations. CDMOs are expected to take part in ownership and responsibility when it comes to the quality of drugs and compliance with various government rules. This process can be a challenging area for CDMOs, especially true when you consider the vast databases and maintenance required to remain compliant.

FIGURE 1: Key Serialization Challenges Faced by CDMOs

  • Picking the Right Labelling Solution
    When it comes to the serialization of drugs, there should never be a one-size-fits-all approach to labeling solutions. From label materials to the hardware used including, Thermal Inkjet Technology, Thermal Transfer Technology, Laser Printers, Digital Printers, etc., CDMOs have a lot of decisions to make. Label layout, orientation, barcode design, compliance adherence, and validation, and these labels need to be manufactured in a stipulated amount of time for maintaining the continuity of the drug’s supply chain. This all comes down to making the right choice when it comes to coding and labeling technology.
  • Understanding Market Requirements
    While larger pharmaceutical manufacturing companies may have an in-house team of analytics and marketing specialists; mid-size and virtual companies often still rely on CDMOs for market intelligence.When it comes to serializing drugs of their clients, CDMOs need to understand the different markets and their requirements. Based on market analysis, CDMOs make a decision as to how many drugs need to be serialized for a particular market, including whether they’re choosing to use randomized or centralized serializations.

Different ways CDMOs can overcome Pharma Serialization Challenges

As every case is different, it’s unknown which factors may be bigger issues than others. To be able to address these challenges as they come, CDMOs should evaluate the following points

  • In order to set a robust pharma serialization system in place, CDMOs should equip their task force with the technical knowledge and details of serialization hardware and software beforehand.
  • Making use of advanced technological applications like Big Data, Cloud, Internet of Things (IoT), advanced analytics, or enterprise-level software, like Microsoft’s Dynamics 365 line will help CDMOs in maintaining and monitoring their database for various clients. They should have no problems managing multiple production lines while serializing drugs for different clients.
  • Investing in the right partner, with experts that understand and cater to diverse global and local pharmaceutical rules and regulations will prove hugely beneficial for CDMOs in their pharmaceutical serialization track & trace journey.
  • As a vendor, it’s important for CDMOs to maintain two-way communication with all parties involved, including the pharmaceutical companies, dealers, wholesalers, packagers, transporters, etc. This will help them maintain transparency at every level of serialization and aid in avoiding recalls or stock-outs.
  • CDMOs can benefit greatly by developing flexible templates for their serialization solutions. These templates would serve as a blueprint for any pharmaceutical client, while the flexibility in the template would allow a CDMO to make tweaks in the process to meet the client’s requirements. This saves time, effort, and cost.

Final Thoughts

While drug serialization can create a number of different challenges for CDMOs, it’s also an opportunity for an organization to display technological dominance. Regardless, with the right team and solution in place, CDMOs should have no problems managing any challenge they come against.

Microsoft’s Dynamics 365 suite of solutions offers Pharmaceutical companies a powerful solution, and a means to track serialization along with handling customer onboarding, lot traceability, and toll manufacturing processes, from start to finish.

  • As pharmaceutical companies are required to strictly follow serialization regulations to combat counterfeiting, theft, and more, these companies are partnering with CDMOs for better serialization and to establish a more efficient supply chain.
  • Serialization requirements for pharmaceuticals pose many technical and skill-based challenges and CDMOs worldwide are constantly looking for more efficient ways to handle these challenges, investing in the right partner can make a big difference.
  • With the help of cutting-edge applications, a skilled team, and a systematic approach towards serialization, CDMOs can establish themselves as leading end-to-end manufacturing and distribution partners for leading pharmaceutical companies.

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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

Predictive analytics in the pharmaceutical industry: Key Use Cases

Predictive analytics in the pharmaceutical industry: Key Use Cases 1500 752 Xcelpros Team

At a Glance

  • The digital era has given companies various tools and techniques to help pharmaceutical manufacturers optimize and streamline their operations, and predictive analysis is one such highly advanced method.
  • There are different ways with which predictive analytics can integrate with existing software setup and forecast plausible technical glitches and predict future trends, thus helping in enhancing operational efficiency.
  • Predictive analysis can help planning to execution, aftermarket services level to develop better products/ services, improve their response time, and stay ahead of the curve for delivering better customer experience.

The Role of Robust Infrastructure

Database management has become one of the topmost priorities for companies across the globe. This database is used to fabricate trends and patterns for a particular time-frame or a process or a product. Data historians have been around for quite some time now, but manufacturers have recently started to look at them as more than software that stores and retrieves data. Application of predictive analytics is turning out to be a game-changer in terms of predicting the future with maximum accuracy and helping manufacturers make the right calls across various functions- purchase, operations, consumer demands, marketing, and more.

Any business operates with the ultimate motive – to enhance productivity and profits. Optimizing operations thus becomes a must for manufacturers. Companies are riding the digital wave with cutting-edge technologies and tools such as Cloud, Internet of Things (IoT), Machine Learning, and Digital Analytics. By making the most of this digital disruption and using predictive analysis to their advantage, companies can achieve better operational efficiency and higher productivity.

Increased and better predictability for both structured and unstructured data helps companies in planning their operations accordingly for enhanced productivity and a faster pace of work.

Predictive Analytics in Pharmaceutical Operations

Predictive analytics is creating a buzz in the Pharma industry for quite some time now. Different pharmaceutical manufacturing companies are looking to model their business processes by gauging the future requirements. The predictive analysis makes use of data historians to accurately make predictions about future trends, possible glitches, and diversions along the road. While technology has come a long way when it comes to predictive analysis, at an enterprise level, there are many things you can do to make the most of this technique.

93%

of healthcare executives stated that predictive analytics is important to their business’ future.

Source: CIO.com

As major companies are competing to stay ahead, product sales and consumer acceptance of a specific drug are a few contributing factors that help decide on advancing to Predictive analytics.

Here are a few ways that predictive analytics helps Pharmaceutical operations become more streamlined and agile:

01.Predictive analytics assets help in understanding patient needs ahead of time

For years Pharma companies have invested heavily in market research and insight experts to understand various geographies and patient domains. This included research to understand and forecast patient needs and drug usage compliance to help both R&D and manufacturing teams prepare them ahead, thus catering to the requirements of the patient base. Predictive analysis plays a vital role in this domain by taking historian data and mining it to populate trends and patterns that can be used by Pharma companies to decide upon the demand for their product. Advanced digital analytics is also capable of generating models based on consumption density for a particular geography, demographic, and health index of the patient base. A pharmaceutical company, thus, would automatically be empowered by knowing its end customer base better and learn the composition of drugs and approximate quantities to produce. You can, therefore, produce the drugs as per the forecast and restructure your supply chain as per the demand. All this will optimize your operations by streamlining both the production department and your supply chain. This will result in enhanced productivity and reduced risks of stock-outs or inventory influxes.

02.Digital analytics plays an imperative role in predicting plausible manufacturing equipment glitches

Anyone working on a production line can vouch for the fact that faulty equipment can cost fortunes by becoming the reason for slowed down or altogether stopped production for days. What predictive analysis does is that it uses the stored equipment data and runs the algorithms to understand the working patterns of any equipment. This, in turn, helps in generating reports for plausible scenarios of equipment malfunction. The production team can get forewarned and can work on the said equipment beforehand to prevent any glitches. Apart from helping in enhancing the operational efficacy, this can also help in preventing loss due to stalled production.

One can take the predictive analysis a step further and use the trends generated to get into a proactive maintenance mode, rather than a more cumbersome and costlier reactive maintenance option.

9%

uptime improvement can be achieved by ensuring predictive maintenance in factories.

Source: A Report by PWC

03.Predictive analytics enhances operational efficiency by enabling risk assessment

Predicting the actions and production outcome of a batch record has become integral to measuring the performance of a Pharma product line. Predictive analytics helps in this assessment with maximum accuracy. It also helps in proactively foretelling issues risks related to product line performance, which allows Production Managers to mitigate these risks to raise product quality standards, and hence become a key driver in increasing product performance in the market. This could apply to both software and hardware in a production line. The cumulative phenomenon results in better risk assessment. This helps the operations team to proactively plan the course of their actions for a better outcome. The advanced predictive analytics tools integrate with different software used by the manufacturers to recognize patterns, share information with other machines and apply the principles of machine learning to automatically gauge risks and alert the users on a timely basis. For optimized operations, risk aversion plays an important role.

Figure 1Use Cases of Predictive Analytics in Pharma

01

Deriving 360 degree patient journey insights

02

Influencing patient adherence

03

Capturing genomics data to accelerate discovery of precision medicine

04

Speeding up drug discovery and development

05

Improving the efficiency in clinical trials

06

Identifying gaps in compliance to streamline regulations

07

Reducing cost and speeding up time-to-market

08

Improving safety and risk management

09

Managing operations and employee training

10

Taking effective sales and marketing initiatives

04.Advanced analytics is essential in accelerating operations

The ways mentioned above with which advanced predictive analysis helps in operational efficiency have all resulted in more agility in the overall operations. Rapidly delivering drugs to the end customer, is becoming a primary responsibility for Pharma companies within the Pharma Value Chain. Companies see a rapid generation of patterns, demands met with more ease, lower risks in manufacturing processes – advancing production lines, and related functions to be more agile.

Business Scenario

Meridian Medical Technologies, a Pfizer company, continues to experience manufacturing challenges in the production of EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths. These challenges are expected to result in tighter supplies and greater variability in pharmacy-level access at this time.

Added to the shortage of EpiPens due to tighter supplies, the U.S. Food and Drug Administration provided additional information on lots that are about to expire creating further risk in Epipen availability for the patient base.

A good model of predictive analytics in the Pharma supply chain that provides a gauge of stock requirements based on patient demand, in-store inventory, and expiration dates would have mitigated this risk of Epipen outage before it is too late. Time to market is an essential factor in deciding the success of a product. Accelerating pharma manufacturing processes will thus help companies stay ahead in the competition.

Key Takeaways

  • Predictive analytics is highly effective in risk assessment, equipment analysis, trend forecasting, and data mining.
  • Every industry has their specific criterion to make use of predictive analysis to boost sales and with better use of such tools, enterprises will be better prepared to serve their customer base.
  • Manufacturers can benefit highly from this advanced digital technology by optimizing their operations and enhancing the speed of production.
  • Speeding up the drug to the market process by predicting demand based on patient demographic enables Pharma companies to be prepared for the increase in end-customer demand and manage stock outages without compromising patient needs.

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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

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 at this time.
  • These firms are looking for 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 amongst the CROs have led to the onset of a new, evolved era of project management that is more comprehensive improving customer engagement and experience.

The Role of a Contract Research Organization

Project management is considered to be the backbone of any Contract Research Organization be it for biopharmaceutical development, commercialization, preclinical research, clinical research, clinical trial management, or pharmacovigilance. Pharmaceutical/ life sciences companies outsource R&D works to CROs for better time management, test data maintenance, and focus on concrete results and help address the current pandemic.

While the role of CROs was not very well defined in the early 2000s, there has been a gradual evolution of CROs moving from being mere project management vendors to strategic partners for life science organizations. Contract work in various steps of the life cycle from R&D to commercialization and sponsored clinical trials have become a necessity for the research and development wings of any biotechnology or pharmaceutical company.

Active engagement with CROs has proven to help in accelerating the process while managing the details efficiently and now these Contract Research Organizations need to 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.

For any pharmaceutical company, conducting sponsored trials to drive their products safely and quickly to the market is an important aspect of overall project success. Earlier, these projects were outsourced to CROs with a limited scope of time and budget management. However, now the CROs are expected to manage risks, apply newer tools and techniques to maintain transparency throughout the clinical trials and related processes. The Rapidly expanding industry is posing a demand on CROs to keep up with market conditions.

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. Contract Research Organizations Global Market Report

This stat is quickly becoming obsolete due to the current state of affairs and the need for contract research and development services have already grown tremendously to aid the life sciences companies in their quest to find a vaccine for the pandemic.

FIGURE 1 Steps for Right Partner Selection

The growth and general technological disruptions in project management have led to a progressive change in the roles that CROs play while managing the sponsored clinical trials.

What are some of the major areas reflecting this rapid and definite evolution?

  • End-to-End Strategic Partnership: CROs are no longer just outsourced vendors for life sciences companies to carry out Pharma research, or conduct clinical trials in a stipulated amount of time. As the intricacies of the current world have already changed every aspect of project management, CROs are now expected to take complete ownership in the strategic moves of a Pharma company and transform into a strategic partner to make their clients successful. End-to-end coordination with pharmaceutical companies gives Contract Research Organizations enough time and stability to focus on core research. This aids towards capturing the right kind of clinical data to help move the drug forward to commercial markets.
  • Bringing Innovation to the Table: CRO project management is not just about completing given tasks while sticking to some fictitious timelines. The needed collaboration between CROs and their life sciences customers has increased, giving rise to a need for better project management methodologies. These Organizations now handle the ‘cradle to grave’ process of the contract research work. Pharmaceutical companies expect innovative, out-of-the-box solutions to manage risks, cut down costs, and push the boundaries of paramedical science while complying with the government’s rules and regulations. CRO project management has changed from being reactive (problem-solving) to becoming proactive (anticipating the problems and providing feasible solutions for them well in advance).

FIGURE 2 Key Parameters CROs are Assessed on

  • Being Technologically Ahead: Companies can start with 3 main technology initiatives – transitioning to cloud, strong workflows to moving processes/procedures forward, and to use online collaboration tools embedded with the overall infrastructure.

All of these above points are leading to a cumulative phenomenon of faster results, lesser errors, better team management, and overall improved communication between the client and the CRO for the entire project life cycle.

Customer Experience and Engagement

A crucial part of Project Management is to actively engage clients on various projects that require constant collaboration. Customer experience and engagement were given less importance in the past and can no longer be ignored. In order to make the strategic partnership a tactical success for both parties engaged in the contract, proper customer experience and engagement has become a crucial step in the life cycle of the project. If we were to take a 2 pronged approach on how customer experience can be handled, one is through the processes and procedures laid out in the engagement, and the other is through the slew of technologies and tools that can be used to make it a seamless experience.

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

Making some minor tweaks in existing processes and procedures is needed to enhance the customer experience and engagement during a project lifecycle. Below are some of the areas to consider for better CX and CE:

  • Improving team management
  • Quick onboard of experts for clinical trials
  • Effective cost management due to tightened budgets
  • Proactive management of risks in the clinical trial process
  • Mitigation strategies of probable risks
  • Project monitoring and reporting with detailed analytics to better understand research data
  • Effective resource planning to optimize resources for multiple projects.
  • Simplify milestone-based billing
  • Improve deviation-tracking methods to remove unknowns that are notified earlier rather than later in the project lifecycle.

There is a need for a next-generation CX/ CE platform in life sciences organizations: a disruptive platform capable of replacing old generation CRM systems to accelerate development and drive demand. Microsoft Dynamics 365 is one such system that offers all tools and capabilities within one comprehensive ecosystem.

The seamless integration between Dynamics 365, robust cloud and AI offerings, and familiar tools such as Office 365 enables companies to rapidly develop a powerful, intelligent platform. It is a class-leading life science customer engagement platform that functions across mobile devices – which is a large market need.

02.Digital Advancement

This point was covered briefly in section 2 and taking it further, companies would absolutely require the below to enhance their customer experience and engagement:

  • Move from legacy systems to the cloud
  • Use advanced analytics for risk prediction and mitigation
  • Systematically manage their R&D database with digital applications
  • Improve collaboration with clients through collaboration tools
  • Reducing human intervention and semi-automate project management workflows
  • Customer self-service and supplier self-service portals to better manage the engagement from both the customer and a subcontractor’s end
  • In-line reporting through key project milestones to customer to build trust and visibility

03.The Inevitable Evolution

The evolution in the role of CRO to manage R&D through project management is leading to greater expectations by their life sciences clients. Pharmaceutical companies are looking for CROs that are not afraid to push boundaries and are adept at the latest tools and techniques. Since pharmaceutical firms are aiming for greater customer satisfaction, use of latest technologies, and overall better project management, they are engaging with CRO’s at an integral level.

This in turn is causing CROs to be more innovative and agile in their approach when it comes to project management. This interdependent relationship will not only be beneficial for clinical trials, but it will also improve the overall research and development process of a pharmaceutical company. A well-managed and organized workflow-based environment will be of great benefit to both the CRO and their life sciences customers who engage in a contract with them. Microsoft Dynamics 365 Finance and Supply Chain would make a good comprehensive system to aid a CRO to become better strategic partners to Pharma and Biotech companies.

Figure 3How to Create Successful Sourcing Partnerships?

Modernize Finance & Operations: 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 F&O 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

  • Throughout the world, CROs are transforming from a time-bound project management role towards a more performance and results-oriented role in order to keep up with the current state of the market conditions.
  • As technology is evolving, so are the tools of project management. CROs are equipping themselves with these tools for better time management, budget management, and risk mitigation.
  • Technology that allows smoother onboarding of customers and suppliers to handle clinical trials will be a need of the hour. Pharmaceutical companies are looking for CROs who can be their end-to-end project execution partners while providing innovative solutions for seamless research and development or testing processes.
  • While time management and cost management will always be top priorities for CROs when it comes to any project, they will also need to develop adjacent digital competencies to offer more ROI for funds spent by pharmaceutical companies.

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.

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