Complion’s VP of Customer Experience, Keith Martinek talks of the impact Covid had on the execution of clinical trials.
Recently, at DPAHRM 2021 (Disruptive Innovations to Advance Clinical Research), Complions’ VP of Customer Experience, Keith Martinek spoke of the impact Covid had on the execution of clinical trials. Even though inspection and audit-readiness has always been important in the work we perform, Covid forced organizations to be remote, to not work together, and to find new ways to collaborate, and overcome many challenges.
In this short presentation (4:43), Keith outlines the value an eRegulatory / eISF platform can provide Sites, Sponsors, and CROs, while overcoming the challenges brought on by Covid.
Transparency and visibility
Using solutions such as the Complion Platform, Sites, Sponsors, and CROs were able to connect, share documents, share information, and provide transparency in the execution of their work. This gave them the ability to maintain transparency and visibility of all studies in progress, and look at studies in real-time, even during study start up.
Time spent with errors
In an effort to be inspection ready, audit ready, and even monitor visit ready — overcoming time spent with errors dealing with document names, expiration dates, and missing information became paramount. There simply wasn’t the ability to manage these errors in a collaborative, on-site way during Covid. The Complion Platform provides workflows that inform users to enter proper information for each document, essentially shifting the focus to conversations about trial execution, enrollment and patient safety.
Controlling access to documents and study information
These challenges NEVER went away, and are extremely important from a HIPPA, PHI, and PII perspective. Fortunately, the Complion Platform configuration is built in such a way that Sites have access to their data, CRO’s have to their data, and even an FDA Inspector can get appropriate access as needed… with appropriate permissions, of course.
Managing high turn-over
Whether you are a Site, CRO, or a Sponsor, the ability to train new personnel, onboard, perform the necessary transfer of knowledge is challenging especially for a manual, paper-based system, as well as a home-grown solution The Complion Platform allows you to manage eREg/ eISF documentation and onboard new staff, and make it easier for staff to get up to speed.
To learn more about how Complion can help you with your eRegulatory, eISF challenges so that you can achieve faster study start-ups, better oversight, and unprecedented audit readiness, contact us, or request a demonstration today!
Complion is a leading provider of eRegulatory and eISF solutions for Sites, Sponsors and CROs. Founded by a clinical researcher participating in an NIH-funded MD/PhD training program, Complion’s unique cloud-based purpose-built software enables collaboration of site regulatory workflows and the management of essential documents to ensure clinical trials are conducted in an audit ready manner.