INSIGHTS
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Overcoming the Barriers and Risks Related to N of 1 Trials
There has been a sharp increase in the demand for n of 1 trials. Many institutions are vying to become the dominant leader in this space because of the numerous benefits. However, significant challenges are
21 CFR Part 11 – An Overview
Breathe easy knowing your site is compliant. Complion’s team has developed expertise in 21 CFR Part 11 regulations. Not only is our platform Part 11 compliant, we will partner with you to do everything required
21 CFR Part 11 – Compliance
Breathe easy knowing your site is compliant! In part 1, we provided an overview of Rule 21 CFR Part 11 which covered the rise of electronic records and signatures, what is 21 CFR Part
The Role of IRBs in Clinical Research: A Quick Guide
Institutional review boards (IRBs) are ethics review committees that ensure human research subjects’ rights are protected, as well as the rights of the patients who ultimately benefit from the research. Operating under US federal regulations, state laws, and institutional policies, the IRB has the authority to approve, require modification to, and disapprove research. IRBs are an important part of regulatory efforts and their approval is required for all human research. Here’s a quick overview of IRBs and the expectations for working with them.
Part 1: How Coastal Pediatric Selected 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 first of this three-part series, we take a look at the selection phase of the adoption of an eRegulatory solution.
Integrate with best-of-breed to accelerate site startup and closeout
How to connect WCG IRB Connexus and WCG Velos eResearch CTMS with your eReg/eISF Are delays in site initiation visits (SIV), first person / first visit (FPFV), and delays in getting studies closed creating unnecessary
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