Transformational Technology Front and Center at ClinTech

At the ClinTech conference this year, I was excited to hear industry leaders discuss how next-generation technologies are helping them transform their businesses and strengthen compliance. In fact, implementing “transformational” eTMFs was one of the topics of discussion at ClinTech.

Increasingly, organizations are adopting modern, end-to-end content management systems that  both enable employees and collaborators to efficiently contribute to the TMF – and help auditors reconstruct the trial based on TMF documents. An on-premise TMF with paper-based processes creates extra effort for organizations and auditors to meet their goals.

During the course of trials, exchanging paper documents between multiple parties is time and resource intensive – the potential pitfalls, inefficiencies, and headaches are well known in the clinical space. Cloud-based eTMF applications provide electronic workflows to facilitate collaboration, as well as the ability to easily report on document status. It’s simple for organizations to track progress, auditors to monitor TMF completion, and external collaborators to access one secure location in the cloud – any time, anywhere.

Life sciences companies are moving away from inflexible legacy systems and toward modern cloud applications that support today’s distributed operations. This move to cloud should enable all parties to do a better job of keeping the TMF inspection ready. This is particularly important given the MHRA’s recent update to their definition of GCP inspection findings. “Over the last year, 35% of commercial sponsor inspections have resulted in extra days having to be added to complete inspections where there have been difficulties ensuring the TMF is complete and readily available,” states the MHRA update.