A lot of work is being invested to ensure research site audit readiness, oversight, and completeness of regulatory files or binders. Unfortunately, there is a lack of understanding if everything is being done to the level of completeness, accuracy and quality that is required. As a result, site regulatory can be a real challenge for Sponsors and CROs.
Complion, Inc. has joined #NoGoingBack, an industry-wide social movement which focuses on keeping in place the clinical research advancements gained during the COVID-19 pandemic.
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.
There are limitations to how much property can be protected after a disaster. In the case of clinical research sites, paper documents can burn, or they can be damaged or destroyed by smoke and water. An important consideration for sites is to develop a disaster preparedness strategy with a focus on transitioning to paperless documentation by moving critical study documents to a digital format.
This Complion question and answer session held with Dr. Harvey Arbit, an adjunct professor at the University of Minnesota College of Pharmacy, provides insights into achieving stress-free FDA inspections.
While electronic document management is becoming more mainstream, it’s still considered uncharted territory for some research sites. The transition is often approached with trepidation, fear, and questions. Complion has found sponsor pushback to be a common concern. To that end, Complion offers a few tips to ease the apprehension.