Quality Data – How Resourcing Challenges Can Affect Clinical Trial Outcomes

By Dr. Armand Czaplinski and Kevin Duffy, KPS Life

Personnel shortages and expertise gaps across the biopharmaceutical research and development paradigm have widespread implications for the time and expense associated with the drug discovery phase, already beset with competing challenges and an ever-evolving Regulatory landscape. These factors have compelled many sponsors to explore decentralized clinical trials (DCTs) as a solution to the rigors of conventional onsite trials and their commensurate workforce needs. But this approach is also not without its pitfalls: for many, DCTs require an aggressive technology transformation plan, often involving an overhaul of their systems, network size and workflows, which can be further complicated depending on the country or region of the world where the trial is being conducted.

All of these factors serve to create a challenging landscape for the global labor market in life sciences. Biopharmaceutical companies can employ several strategic approaches to mitigate risk in this regard, addressing the evolving demographics of the global workforce and ultimately transforming their own paradigms to ensure their programs succeed. Functional Service Providers (FSPs) can offer sponsors a more cost-effective alternative providing a complementary and/or supplemental partner to their existing outsourcing strategy. This can afford them access to tailored expertise, experienced clinical monitors, FSO oversight monitoring and global project management without any appreciable change in their existing workflows. Download the complete article in PDF to learn how a biopharma can leverage an FSP or FSP/CRO hybrid to address workforce gaps and rescue floundering studies.

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