admin 
eRegulatory binders help clinical sites organize and digitize the regulatory process, but each binder is different depending on the specific clinical trial site protocol. Here, we provide an overview of the specific sections and documents that must be included for an FDA-regulated study.
The sheer volume of data produced by the clinical trial industry is staggering—and it’s growing every day. The healthcare industry, in general, relies on big data to function, and clinical trials are no exception. We need speedy, secure access to data sets that are large, complex, and diverse. By and large, big data has moved … Read more
While those of us who work in the clinical trial space have always known that the importance of our work cannot be overstated, there’s no question that the COVID-19 pandemic has driven home the importance of the clinical trials industry to the rest of the world as well. As we reflect back on the events … Read more
Ah, the dreaded site assessment and feasibility: pages upon pages of requests for information. From equipment specifications to investigator experience to patient population, the amount of data needed to execute a clinical trial feasibility is onerous. You may have most of this information on hand—across a variety of spreadsheets, emails, documents—and in your head. But … Read more
One of the biggest challenges that clinical research organizations face is managing their vast influx of clinical trial opportunities from Sponsors, CROs and other potential sources. As anyone in this industry knows, there’s a lot of effort that goes into starting up a clinical trial; from sourcing the trial, to feasibility and site selection, to … Read more
The investigator site file (ISF) plays a critical role in a study’s success. But only if the people in charge of it – clinical trial investigators – keep its contents accurate and up to date. In this post, we provide an overview of all essential documentation in an effective, compliant ISF.
Bridging data gaps in the clinical trial space can be the deciding factor in losing and securing clinical trial opportunities. If you’re in the role of business development, you’re likely the one who is most concerned with bridging these gaps, hitting your clinical trial targets, and winning more awards. But do not fret, because once … Read more
San Antonio, TX — RealTime Software Solutions, LLC now offers ‘Sign on the Line’ technology integrated across all CTMS and eDOCS systems at no additional cost to customers to address concerns of clinical research site auditors and regulators. The new ‘Sign on the Line’ software feature utilizes similar technology as major signature companies such as … Read more
August is National Immunization Awareness Month. To celebrate, RealTime wants to thank all the individuals and organizations who contribute to the production of new vaccines, such as the one developed for COVID-19. From sponsors and sites to investigators and patients, there are many people to thank for their contributions to a healthier world. RealTime is … Read more
As technology evolves, so must we. We can’t settle for the same technology just because that’s the system we’ve always used. In our previous blog, “5 Things to Look for in an eRegulatory System,” we discussed what to look for in an eRegulatory system for clinical trial management. User experience, a monitoring portal, secure centralized … Read more