TECHNOLOGY & DATA MANAGEMENT Picking the right sized partner MATTHEW BARNES, BS AND SHEILA A. MATHIAS, PHD
Matthew Barnes, Senior Director, Portfolio Management, Virpax Pharmaceuticals, Inc. and Sheila A. Mathias, Chief Scientific Officer, Virpax Pharmaceuticals, Inc.
T
he pharmaceutical development world has companies of all sizes. From two-person start-up biotechs, to global pharmaceutical companies
with tens of thousands of employees worldwide, and everything in-between. Similarly, supporting vendors and CROs can be as small as a single person independent specialty consultant to a global CRO. Picking the right partners that can work as seamlessly as possible with your organisation is critical and deserves careful consideration. This decision should never be simplified to a single element, such as cost or simple intuition. Rather, careful application of critical thinking about study designs, data management and data collection, systems, regulatory strategy, pharmacovigilance, and medical writing should be applied. Furthermore, the use of simple risk analysis tools can provide a robust framework for making the best possible decision that will increase the probability of success for a program. Factors that should be considered include cultural fit, experience,
36 | Outsourcing in Clinical Trials Handbook
flexibility, scalability, and communication process. The right partner needs to have the ability to navigate pathways and obstacles.
Cultural fit: Factors of the essence to consider are trust, teamwork, transparency. These factors should go both ways. Does the partner’s values and mission align with the Sponsor’s?
Evaluating expertise: Well-designed clinical studies are the core of criticality to successful development of drugs and devices. Vetting at least three partners that includes a discussion on how they would organise the study. This is important as there are many reasons that clinical trials can fail from a lack of a proper study design, improper dose selection, and issues with how the data is analysed to name a few.
Flexibility and scalability: While clinical trials are ongoing there will be moments when resources may have to be reevaluated. Does the partner have this flexibility?
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