Solutions

RealTime announces the release of eDOCS-LITE. This CTMS-integrated eDocument platform will provide a part-11 compliant document management system for sites. eDOCS-LITE is a free version of eDOCS that will have many of the great features of the full version of RealTime-eDOCS such as a Professional, Education and Training Tracking (PETT) system, an upgraded document management system, electronic signatures, complete audit trails, version control, study and subject document storage, and more. For the first time ever, sites can now have all of the features of a robust CTMS combined with an efficient document management system in a single, integrated platform. With a simple upgrade from eDOCS-LITE, customers can also enable the complete eRegulatory management system, RealTime-eDOCS, which has even more features and storage capacity to go completely paperless with regulator binders. Now, all in a single system, customers can have CTMS, PAY, TEXT, and eDOCS-Lite or eDOCS.

Traditionally, the clinical research industry has utilized a top-down model when adopting new technology.  In this model, sponsors and contract research organizations (CROs) have been seen as the innovators in the industry by adopting new technology and pushing that technology down to research sites for collection of records and data.  Instead of surfing the wave of technology that’s hitting the research industry, research sites have been spectators as the sponsors and CROs have all the fun.   This model has been both good and bad for the industry.  While some new technology is best implemented from the top-down, this model has created more efficiency for sponsors and CROs than it has for investigator sites, specifically when it comes to electronic regulatory systems.  These well-intended systems seem to focus more on what is easiest for sponsors and CROs to receive their records from sites and less on what will be most efficient for investigators to actually collect and maintain those records on-site.  The main end-users of this technology, investigator staff, seem to be left out of the equation.

To truly increase efficiency in the clinical research industry, it’s time that the industry opens up more to a bottom-up model of adopting technology.  In this approach, research sites are able to compliment certain sponsor/CRO technologies by adopting their own standard electronic systems (e.g., eRegulatory).  This approach allows investigator sites to reduce their workload while making records easily accessible by sponsors/CROs.   While the top-down approach for adopting technology has helped our industry advance in numerous ways, research sites also desire to be innovators.   Most importantly, research sites want to adopt technology that streamlines their own company processes and increases their viability as a business.  After all, an efficient and profitable site will produce better quality research data, increase their ability to monitor subject safety, and ensure its ability to thrive and continue to serve the advancement of medicine.  When sites adopt site-centric technology and take control of their own company processes, the sponsor, CRO, investigator, study participants, and society as a whole all win in the process.

Electronic regulatory systems from the top-down model typically lack key features that are needed to reduce the workload for research sites.  In fact, these systems most likely add additional workload and increase redundant filing since sites still have to file mounds of paper records to maintain a complete investigator site file.  Upon further inspection, these top-down systems typically limit the amount of users that a site can have which limits collaboration within the research site.  These systems also routinely lack electronic signatures and centralized filing for common records.  On top of these issues, sites are being asked to complete lengthy training sessions on multiple systems with several sponsors which leads to a laundry list of usernames and passwords to memorize and a variety of filing processes to follow.

All of these issues, and more, can be resolved with site-centric technology.  With our experience implementing RealTime-eDOCS™ with our customers, many sponsors and CROs are already leading the way on this issue by fully engaging with innovative sites that adopt their own regulatory document management system.  With the right eRegulatory system, sponsors realize that they gain as much benefit as the research site.  Site-centric technology shouldn’t be feared by sponsors or CROs but should be embraced.

At RealTime Software Solutions, LLC we are actively pushing for a bottom-up approach to solve issues that research sites face every day while also improving relationships between sites, sponsors and CROs.  The top-down model is very dominant in our industry but RealTime’s affordable solutions are now changing the paradigm and giving research sites the technology they need to regain control of their process and improve the research industry.

With high overhead and low profit margins for research sites, it’s vital to streamline processes and reduce the workload associated with maintaining regulatory compliance.  Sites that maintain paper regulatory binders instead of adopting an electronic system are missing out on increased efficiency, cost savings and improved regulatory compliance.  The following are reasons for sites to ditch the paper and go electronic.

The relentless regulatory burden on sites.  The regulatory burden on sites is growing but budgets with sponsors and CROs aren’t keeping up.  Paper-based regulatory processes only exacerbate the problem.  Going electronic can eliminate or reduce most of the clerical tasks associated with paper (e.g., printing/filing/scanning records, managing correspondence, preparing for audits/inspections, and reviewing documents with monitors.).  Instead of searching, scanning and emailing records to monitors, wouldn’t it be nice if monitors simply accessed critical records through a remote web-portal?

The need for improved regulatory compliance.  With compliance-ready electronic systems, sites can immediately adopt processes that improve regulatory compliance across all studies.  With the efficiency created by an eRegulatory system, sites will be audit-ready from study startup to closeout and beyond.

Standardized filing creates efficiency.  When working with multiple sponsors/CROs, each regulatory binder will have a unique way of filing paper records.  With an eRegulatory system, sites regain control of their processes to standardize their filing system and create efficiency across all studies.

Centralized filing will reduce redundant work.  Are you tired of having to file the same CV, medical license, or training record across multiple studies?  If you choose the right eRegulatory system, this task will be a thing of the past.  Simply upload the record one time and have it automatically filed across assigned studies.  The same can be achieved with site level documents, such as temperature logs and equipment calibration records.

Electronic signatures will streamline your processes.  Electronic signatures will dramatically increase efficiency for sites.  No longer do we have to hunt down wet-ink signatures from doctors and staff.  Some sites literally mail documents using “snail mail” and have to wait for the record to be mailed back to obtain signatures.  Other sites are having to drive around the city visiting various doctor offices.  Let’s stop the signature madness and go electronic to save time, money and hassle.

It’s time to eliminate Houdini records.  At some point, we’ve all had to thumb through a paper regulatory binder trying to locate a document that may or may not have been properly filed sometime within the last 1 to 100 years?  It’s very common, especially during audits and inspections, to discover paper records missing without explanation.  The great news is that electronic files don’t go missing once they have been uploaded into a Part 11 compliant eRegulatory system.

Opportunity cost can kill your business.  Let’s face it, if your staff isn’t recruiting patients for studies and conducting study visits, it’s hard to stay in business.  With the right eRegulatory system, your staff will spend less time filing records and more time generating revenue.  Even if your site utilizes dedicated regulatory staff, there is opportunity for them to easily manage more studies using an eRegulatory system.

Purchasing materials and archiving paper records is costly.  It’s not cheap purchasing paper, ink, binders, copy machines and more to keep a research site in motion.  Add up the materials, I dare you.  It’s also no small feat to box and label records to store either onsite or offsite, both of which are costly methods of long-term storage.  Every site I have worked for has literally had to round up a group of employees to stay late at work organizing and archiving paper records.  Reduce the need for materials and eliminate “late night archiving parties” with your staff by going electronic.

It’s win-win for everyone.  Electronic systems aren’t just for large sites looking to streamline processes and reduce overhead.  Small sites can realize the same benefits.  In fact, smaller sites utilizing an eRegulatory system will be much more prepared for growth as more research studies come through their pipeline.  In addition, sponsors and CROs also benefit from site-centric eRegulatory systems.  Through web-portal access, they can easily monitor records from anywhere with an internet connection, saving them time during site visits and reducing travel costs.

Paper binders are completely useless.  Paper-based regulatory binders are now useless given the technology available to research sites.  I take that back, if you stack your regulatory binders perfectly, you can create towers and walls which can be used to build forts for playtime.  Even then, you have created an extreme safety hazard and your HR department will not be happy.

It’s my belief that paper binders are the “dinosaurs” of clinical research and should remain in the past.  With our site-centric eRegulatory system, RealTime-eDOCS, it’s now easier than ever to trade these ancient paper wasting dinosaurs for an efficient electronic system.  Learn how other sites are ditching their paper regulatory binders and moving towards electronic freedom by visiting our website to learn more about RealTime-eDOCS.  Better yet, contact us for an online demo to see the system in action!