Could Technology Supplant CROs?

Applied Clinical Trials, Applied Clinical Trials-09-01-2021, Volume 30, Issue 9

A move back to in-house management of clinops could be on the horizon for sponsors.

In this month’s main feature, “The Post-Pandemic CRO Landscape,” our contributor casually introduced this possibility. Could advances in technology across the clinical trials board correlate to a decreased use of CROs and a move to bring clinical trials operations back in-house to the sponsor?

Prior to the pandemic, I traveled to numerous conferences where sponsor speakers shared experiences of bringing their trials back in-house. Usually they were on a smaller scale–a pilot of sorts–but still interesting. In an interview for the main feature, Peter Benton, President and Co-CEO of Worldwide Clinical Trials, noted: “In some cases, larger sponsors are taking their CRO services in house, bringing on their own tech stack, labs, and employees. It will be interesting to see how this strategy will serve them over the long term.”

For as long as CROs have been around, technology has been a competitive differentiator. Consider Parexel’s early (2005) purchase of Perceptive Informatics. The CRO wanted to capitalize on the technology firm’s portfolio including cutting-edge clinical solutions at the time—web-based portal solutions, tracking tools, IVRS, CTMS, electronic diary and investigator database solutions, as well as medical diagnostics services.

In this issue, three CROs discuss their use of Veeva Systems’ solutions to increase their capabilities for agile study design and artificial intelligence to execute trials for their clients.

Similarly, Oracle reports in the main feature more CROs looking to the company to design agile systems to address their clients’ needs.

Sponsors, too, could take advantage of the plethora of agile solutions, but is that a reality? Benton believes that clinical trials are a quintessentially human endeavor, and technology a tool. “The human touch will always be needed in clinical trials, and CROs will still have an important role to play in providing strategic guidance, analysis, confirmation—all things that technology can support but cannot entirely replace. CROs that embrace the new technology and innovation will lead the industry rather than being left to fear the outcomes of change.”

With almost 80% of clinical trials in the hands of a CRO, it would be a revolution of sorts if all went back in-house. Benton points to the sponsors’ ultimate responsibility for regulatory risk of bringing new pharmaceutical offerings to market. “Bringing the CRO activities in-house, however, means that the organization isn’t just responsible for the regulatory outcomes, they would newly assume the operational risks as well.” A point well taken.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mjhlifesciences.com.