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 … Read more
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
Why does compliance matter when using an electronic system? Many established electronic systems provide research organizations a means to hold and secure valuable clinical research documents and data in a paperless environment that allow for greater site and sponsor efficiencies. These systems may include capabilities that span from recruitment tools, enrollment tracking, calendaring and appointment … Read more
Due to increasing demand and shift to paperless research systems, it is vital to ask the right questions when searching for a site-based eRegulatory system. Sites can utilize eRegulatory systems to streamline regulatory processes, maximize cost-effectiveness, and make study information more accessible. These are some basic questions to ask when searching for an eRegualtory system. … Read more
Many clinical research sites and sponsors are accepting new paperless processes in light of the novel COVID-19 crisis. With the inevitable switch to paperless clinical trial systems, one can hope that the same industry guidelines are equally enforced. With any process, there are rules; the clinical research process is no different with most prescription drugs … Read more
During this challenging time, maintaining clinical trial progression is a novel challenge as on-site data and regulatory reviews are either impossible or extremely limited. Travel limitations and “stay home” initiatives across the country have hindered the way clinical trial data is handled. Many clinical research sites and sponsors are left without the data records needed … Read more
San Antonio, TX – As COVID-19 clinical trials start to ramp up around the country, the research industry has struggled to continue operating. As more and more cities implement orders to shelter in place, the way clinical trials are monitored has faced a challenge. RealTime Software Solutions, a San Antonio based software company, is giving … Read more
Each year, RealTime attends a variety of conferences around the globe in hopes of aiding clinical research professionals, sites, sponsors and CROs on their paperless journey. RealTime attended ACRP in Nashville, Tennessee this April and the team had the opportunity to network with professionals in the industry while gaining insight into the realm of clinical research … Read more
RealTime is dedicated to providing exceptional support, which is why we search for team members that go above and beyond for our customers. Our goal as a team is to give back to clinical researchers by creating software that is more efficient, reliable, and easy to use. This month, we feature one of our amazing … Read more
This year has been an exciting journey for the entire RealTime team! As we look back at our 2018 progression, it’s hard to imagine that twelve months have already flown by. In 2018 we accomplished major new advancements in ALL of our systems. The RealTime SOMS (Site Operations Management System) is one-of-a-kind, and the solutions … 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.
