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.
Ah, the dreaded site assessment and feasibility: pages upon pages of requests for information. From equipment specifications to investigator experience to patient population, the amount of data needed to execute a clinical trial feasibility is onerous. You may have most of this information on hand—across a variety of spreadsheets, emails, documents—and in your head. But … Read more
Clinical researchers are looking for ways to reduce the operational challenges of clinical trials which can often occur by working with multiple sponsors. Some of these challenges include working with individual sponsor portals, using disparate processes and numerous platforms — each with a unique login credential – which can all lead to increased probability for error and placing patient safety in jeopardy.
As a result, a Shared Investigator Platform (SIP) integration, which can streamline the interaction with multiple sponsors, has become a high priority for many sites.
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.
Let’s face it, we have a paper problem. In a recent webinar, RealTime’s CEO, Rick Greenfield spoke about the existing “paper problem” in the clinical research industry and ways that we can overcome it to achieve “Paperless Nirvana”. As you already know, the Clinical Research Process primarily functions off of paper source documentation and manually … Read more
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