RealTime Software Solutions, LLC, a leader in cloud-based software solutions for the clinical research industry, is pleased to announce the acquisition of Complion, Inc., a leading electronic regulatory (eReg)/electronic Investigator Site Files (eISF) solution provider for clinical research sites, academic medical centers (AMCs), hospitals, health systems, sponsors and contract research organizations (CROs).
Realtime Software Solutions today announced it is launching the Beta phase of its ‘ENGAGE!’ family of software solutions featuring the first clinical research site-based participant portal, MyStudyManager™, and RealTime-eCONSENT.
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 preventing scaling these trial types, primarily regulatory compliance. Leading research institutions rely on Complion eRegulatory to help overcome these barriers.
SAN ANTONIO, TX, Aug. 8, 2022 – RealTime Software Solutions, LLC, a leader in the clinical trials software solutions industry, is pleased to announce that Stephen Johnson has been named CEO. Rick Greenfield, BBA-IS, will transition into the role of Founder & President and remain highly engaged in the company as the leader of the
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.
