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 for compliance, including validation, training and process development. 21 CFR Part 11 Compliance for Clinical Research Sites Clinical research sites
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 11, why does it exist, and the risk of non-compliance. In this post, we’ll dig into how you can stay
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.
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.
February 8, 2022, San Antonio — RealTime Software Solutions, LLC has released the inSITES Report Builder, a powerful custom reporting tool built into RealTime’s leading Clinical Trial Management System (CTMS) that now allows all customers, at no additional charge, to build and save their own customized reports to monitor site-wide performance and maximize efficiencies and
Complion accelerates site startup and closeout with eISF/eReg integration to WCG IRB Connexus and WCG Velos eResearch CTMS CLEVELAND, OH, February 4, 2022 – Complion and WCG IRB, the first eISF/eReg and cIRB respectively, have announced today the first and only eISF connected to WCG to accelerate the management of IRB documentation throughout the entire
San Antonio, TX – Jan. 13, 2022 – RealTime Software Solutions, LLC, a leader in cloud-based software solutions for the clinical research industry, today announced a significant growth investment from LLR Partners. The capital and resources from this partnership will be dedicated to helping accelerate the company’s growth, product innovation and delivery of world-class customer
At the core of Devana Solutions’ mission—to connect central research operations teams to decentralized clinicians serving patients in diverse community settings—is the goal of reducing drug development costs and curing disease. That’s why Devana partners with Greater Gift, a 501 (c)(3) non-profit organization that “honors patient volunteers and research professionals who make clinical trials possible,” by
RealTime eClinical Solutions is a leading, enterprise-grade technology provider facilitating global clinical trials with a comprehensive eClinical platform. Purpose-built for clinical research sites, site networks, academic medical centers, sponsors, and CROs, the platform goes beyond traditional CTMS to empower research and business workflows for modern-day clinical trials.
