In Mastering FDA Audit Preparedness: Streaming Compliance and Easing Site Burden, a webinar hosted by Complion, an audience poll revealed that 48% of attendees spend anywhere between 6-10 hours, on average, preparing for an audit.
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 first of this three-part series, we take a look at the selection phase of the adoption of an eRegulatory solution.
Approximately 80 percent of clinical research sites polled in a recent Complion, Inc.-sponsored survey said the costs and burden associated with administrative tasks for a single study has increased over the past two years, continuing a five-year upward trend.
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 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.
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.
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.
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.
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