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.
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.
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
- 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.
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.
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