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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 … Read more
These integrations combined with the RealTime-CTMS, they can help you take your clinical research performance to the next level.
Since the beginning of the COVID-19 pandemic, more and more organizations have been exploring the possibilities of decentralized clinical trials (DCTs). Decentralized trials have many benefits, including accelerated patient access, improved patient engagement and retention, and increased diversity. Unfortunately, these benefits also come with challenges such as reduced collaboration and limited data access. Clinical trial … Read more
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.
Devana Solutions CEO Barry Lake recently sat down with Brad Hightower of the Note to File Podcast to discuss the current state of the industry and the importance of sites tracking their own metrics using clinical trial software like Devana Solutions. Offering holistic trial analysis and a dynamic site and investigator database, Devana Solution’s enterprise software gives businesses the crucial support … Read more
Sponsors, CROs, sites and clinical trial vendors work so very hard to make clinical trials successful. This arduous work includes protocol development, regulatory approvals, trial management, vendor selection, site selection, start-up, and effective participant recruitment just to get the study off the ground. But one fact remains consistent today: Study participants, the most valuable part … Read more
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.
The relationship between sponsors and contract research organizations (CROs) is strengthening as outsourcing becomes a clinical trial norm. It is important for the CRO to have a good working relationship with sites in order to ensure that the trial is successful, particularly in the study startup phase, as clinical trials are increasingly expensive and time-consuming … Read more
Learn more about the features eDOCS Lite provides research sites to streamline documentation within one system.
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 bottlenecks and frustrations running a clinical research study? Is the lack of visibility and control frustrating your ability to monitor … Read more
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.
