Clinical Researcher—March 2020 (Volume 34, Issue 3)
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The clinical research process, especially as it relates to data, primarily functions off paper source documentation and manually transcribed data into electronic data capture (EDC) systems. Most clinical research sites are still utilizing paper regulatory processes. Due to these primarily paper-based systems, there are numerous inefficiencies and detriments to the speed and accuracy of the clinical research process. So why are many sites still using paper-based research systems?
As it relates to advanced research systems, U.S. Food and Drug Administration (FDA) regulations have paved the way for electronic document storage, eSignatures, and EDC. However, there is still an evident uncertainty in the industry about the FDA’s acceptance of a paperless process. The slow adoption of these advanced systems, unfortunately, is holding back the clinical research industry from a much more efficient and cost-effective future.
The Top-Down Approach
The top-down (or sponsor-driven) approach to adopting advance research systems has proven to be a long-winded process. Adherence to site policies and procedures for data accuracy, Good Clinical Practices, regulatory compliance, and protocol compliance makes transitioning to paperless systems a significant hurdle. Current top-down systems do not have the users’ (site staff and doctors) needs in mind regarding workflow and ease of use.
The shift to advanced research systems such as eDOCS and eSOURCE is inevitable. Additionally, EDC vendors need to help pave the way by offering intuitive data sync capabilities that will bring value to all parties and keep EDC companies relevant in this inevitable shift. As sites adopt site-based eSOURCE and eDOCS systems, the need to efficiently transfer files and data into sponsor-managed electronic trial master file (eTMF) systems and EDC systems will become imperative. The pendulum has shifted! Advanced electronic systems are proving their value across all organizations!
So, what are you waiting for?
Take the next step to adopting advances research software solutions! RealTime-CTMS (Clinical Trial Management Systems) can function on a single site, multisite, or enterprise level. With add-on features such as eDOCS, eSOURCE, TEXT, and SitePAY, RealTime can deliver the one-and-only Site Operations Management System (SOMS) for an end-to-end solution.
To learn more about going paperless, fill out a CONTACT FORM, or call 210-852-4310 to speak to an expert today!