The development of standards is a proven methodology for efficiency and quality. By implementing an eRegulatory solution, research institutions have the opportunity to standardize clinical trial documentation and processes.
The characteristic increases in efficiency as a result of transitioning to a streamlined paperless operation are of little value if the transformed organization fails to be 21 CFR Part 11 compliant. It’s critical every step to paperless transformation is guided by professionals who are skilled in the requirements for compliance.
We explore Coastal Pediatric Research’s journey to adopting Complion’s eRegulatory solution which has enabled the site to increase efficiency, greatly improve time management, and eliminate duplication of work while conducting their clinical research studies. In the last post of this three-part series, we take a look at the training phase when adopting an eRegulatory solution.
In terms of the service a research site provides to the sponsor of a study, regulatory work is of utmost importance. Regulatory teams are burdened with figuring out how to make sure this critical work is done even when all the parties involved in the study are not in the same room. This is particularly true during this pandemic. So how do regulatory teams provide the highest quality especially during this time?
Society for Clinical Research Sites (SCRS) sought the answer to that question in a recent episode of the organization’s “SCRS Talks” podcast series when they interviewed Complion CEO Rick Arlow.
We explore Coastal Pediatric Research’s journey to adopting Complion’s eRegulatory solution which has enabled the site to increase efficiency, greatly improve time management, and eliminate duplication of work while conducting their clinical research studies. In the second of this three-part series, we take a look at the implementation phase of the adoption of an eRegulatory solution.
As a research coordinator or administrator, being buried under a mountain of paper files is not something that has to happen often before it becomes apparent there must be a better way. That better way is an eRegulatory system.
In this age of technology, every aspect of our lives is based on information and computerization. We’re constantly checking our cell phones, posting to social media platforms, or streaming news and other media. In the clinical research world, advancements in technology represent an opportunity to improve efficiency. One such example is remote monitoring which enables sponsors and CROs convenient access to site documentation.
Without question, clinical trials have been dramatically impacted by the rapid spread of COVID-19. There is even more of a demand during this pandemic for eRegulatory solutions that allow staff involved on all sides of this equation—sites, sponsors and CROs – to do their work effectively and efficiently even while needing to distance from one another.
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