INSIGHTS
Important Clinical Research Insights
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The Right eReg Partner Smooths the Path to 21 CFR Part 11 Compliance
The characteristic increases in efficiency as a result of transitioning to a streamlined paperless operation are of little value if the transformed organization fails to be 21 CFR Part 11 compliant. It’s critical every step to paperless transformation is guided by professionals who are skilled in the requirements for compliance.
Part 3: How Coastal Pediatric Trained Staff on 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 last post of this three-part series, we take a look at the training phase when adopting an eRegulatory solution.
‘SCRS Talks’ to Rick Arlow about quality regulatory work during a pandemic
In terms of the service a research site provides to the sponsor of a study, regulatory work is of utmost importance. Regulatory teams are burdened with figuring out how to make sure this critical work is done even when all the parties involved in the study are not in the same room. This is particularly true during this pandemic. So how do regulatory teams provide the highest quality especially during this time?
Society for Clinical Research Sites (SCRS) sought the answer to that question in a recent episode of the organization’s “SCRS Talks” podcast series when they interviewed Complion CEO Rick Arlow.
Part 2: How Coastal Pediatric Implemented 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.
3 requirements for a remote SDR/SDV solution
During this pandemic, a key aspect of remote monitoring that seems to be a source of struggle for the industry is SDR/SDV. This is an extremely extremely risky aspect as sensitive PHI is shared across virtual organizational walls. Fortunately, there is a very simple solution if the right eRegulatory solution is used. This blog post takes a look at the three primary requirements when looking for a remote SDR solution.
The Basics of Coverage Analysis
The topic of billing compliance is a highly prevalent matter in research administration. As such, institutions are continually looking for ways to ensure compliance, one of which is coverage analysis. This post explores the benefits of performing a coverage analysis.
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