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Temitope Keyes: Digitizing clinical trials from paper to decentralized trials
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For this episode we explore the evolution of the collaboration and partnership structure between sponsors, CROs and technology vendors in life sciences with Temitope Keyes, Executive Director of Encapsia. Temitope has had a front row seat to the digitization of the clinical trial process.
We speak about the paper handling system that used to characterise clinical processes, and how “validation” that we now use to refer to systems validation used to refer to the validation of the printed paper. An entire ecosystem of vendors was required to make the paper ecosystem function, and the debate back then was whether to in-source or out-source, say, printing.
The evolution away from paper was absolutely necessary to get an overview of what was actually happening in the trial. The safety issues with Vioxx is an example of how data buried in paper can endanger patients. Data submitted on paper also makes it prohibitive to find trends across trials and drug profiles.
Temitope takes us through the digitization arc of the clinical process starting from the phone-based IVR systems to manage drug supply. Next came the development of the clinical database. Pharmaceutical companies attempted to build them themselves, but the complexity also forced specialisation in the industry and the creation of many of the technology vendors we work with today.
Clinical operations is the most expensive part of a clinical trial budget, because it is human-intensive and humans are expensive. CTMS attempts to help provide an overview of the many people involved in a clinical trial.
As more and more systems started supporting the clinical processes, the cost became prohibitive. CROs entered the space to offer pieces of systems to sponsors for a lower price, and in that way became technology companies themselves.
We also speak about how we brought all the technology together to end-to-end solutions that allow decentralized clinical trials.
Guest:
Temitope Keyes: https://www.linkedin.com/in/temitopekeyes/
Encapsia: https://encapsia.com/
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