Do you REALLY own your CTMS data?

As clinical research sites and site networks become more sophisticated, they’ve come to rely heavily on advanced CTMS, eRegulatory and eSOURCE solutions to manage their full set of clinical operations. The size and complexity of data stored in these systems often includes HIPAA protected subject demographic data, medical and medication history, study-specific enrollment data, financial … Read more

3 Tips for Staying Audit-Ready

3 Tips for Staying Aduit Ready

Maintaining audit-readiness is the best way to ensure that your site is prepared for audits and inspections, both planned and unplanned. This proactive approach prevents headaches and last-minute scrambling by staff in the event of an actual audit.  The following tips will help you ensure that your team is audit-ready. Create Create and establish an … Read more

FAQ: Compliance in Paperless Research Systems

FAQ with Evelyn Jackson

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

5 Things to Look for in an eRegulatory System

5 things with eRegulatory System

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

Keeping research compliant amid the COVID-19 crisis

Keeping research compliant

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

Utilizing Remote Monitoring Study Portals Through a Pandemic

Clinical research using motoring systems

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

Segal Trials Announces eRegulatory Milestone with RealTime-eDOCS

Segal Trials paperless with eDOCS

This June, Segal Trials announced their eRegulatory milestone with RealTime-eDOCS. “Congratulations to our Regulatory Department for going paperless! Electronic documents are safe, secure, and allow for quick and efficient handling of more complex studies- along with reducing our carbon footprint.”  – Segal Trials, LinkedIn Sites like those associated with Segal Trials experience numerous benefits when … Read more

S.O.M.S. for Leading Research Sites

SOMS with RealTime

You have probably heard the term S.O.M.S., but what does it mean?  Quite simply, SOMS stands for Site Operations Management System.  It rhymes with Tom’s… it’s SOMS! OK, now you can say it, but what is it?  In the vast arena of software available for clinical research sites, there is a lot to navigate and … Read more