The adoption of digital solutions is becoming commonplace due to the increased efficiencies of electronic solutions in maintaining compliance in clinical trials. In this blog post, we’ll explore the critical components of going digital with
https://vimeo.com/898629213?share=copy Webinar Date: October 25, 2023 Discover the keys to audit readiness in webinar, “Mastering FDA Audit Preparedness: Streamlining Compliance and Easing Site Burden.” Our panel of experts unpack the potential of eRegulatory solutions in
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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.
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.
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.
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.
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.
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.
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