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.
The investigator site file (ISF) plays a critical role in a study’s success. But only if the people in charge of it – clinical trial investigators – keep its contents accurate and up to date. In this post, we provide an overview of all essential documentation in an effective, compliant ISF.
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.
For many research organizations, the incoming stream of regulatory documents that require printing, routing, signing, and filing is never-ending. But many have not yet made the transition to electronic documents and signatures. In this post, we explore how to transition to an electronic regulatory (eRegulatory) solution.
eRegulatory binders help clinical sites organize and digitize the regulatory process, but each binder is different depending on the specific clinical trial site protocol. Here, we provide an overview of the specific sections and documents that must be included for an FDA-regulated study.