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.
The healthcare and life sciences industry is on a mission for healthier, longer lives for all. Clinical research sites and monitors are facing a number of challenges during the COVID-19 pandemic and they can be overcome with remote monitoring.
Competition in the clinical trials landscape is fierce. For sites looking for more studies, it can be difficult to capture the attention and trust of sponsors and CROs. In this post, we break down what sites should do to keep their study pipeline full.