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Category: eDOCS

23 May 2016
Data management RealTime-CTMS Clinical Trial Management Systems

Ten Great Reasons for Research Sites to Adopt a Site-centric Electronic Regulatory System


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!

09 May 2016
FDA Part 11 Compliance Compliant

What is 21 CFR Part 11?

fda (3)With Part 11 compliant systems now available for investigator sites to streamline processes, some of us are wondering what exactly is 21 CFR Part 11 and why is it important?  Essentially, 21 CFR Part 11 regulations define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Basically, Part 11 allows companies to replace any paper record or hand written signature with an electronic record/signature.

For years now, computers have made individuals more productive while eliminating costs associated with paper-based systems. It’s natural that investigator sites are now wanting to replace paper with electronic records to boost efficiency.  The truth is, every investigator site already has electronic records but most companies are so unsure of Part 11 compliance that they resort to printing paper in fear of being non-compliant with regulations.  Instead of fearing Part 11, it’s much more beneficial to embrace these regulations and realize that Part 11 compliance is not complicated.  Can you imagine a research site with a lot less paper?  Not only does Part 11 make this possible, many research sites are already leading the way to an electronic future by adopting systems that manage their regulatory documentation electronically.

While Part 11 regulations are essential and helpful, many would argue that the actual document lacks detail on implementation.  With the lack of detail, the FDA has since provided guidance documents to assist in implementation and the industry has adopted standards to ensure compliance.

There are three primary areas of 21 CFR Part 11 compliance:

1) Standard Operating Procedures – The software vendor will have about 10 or more SOPs to address their IT infrastructure. These SOPs include, but are not limited to, Data Backup, Data Security, Computer System Validation, and other aspects of computer systems that support electronic records and signatures. It’s important for research sites to explore their own IT infrastructure to ensure SOPs that maintain compliance at the site level.

2) Computer system features – There are numerous standard product features that are implemented to ensure computer system security and data integrity. These features include complete audit trails, access controls, record retention and electronic signatures.

3) Computer System Validation – Part 11 compliant systems must have documented evidence that the system does what is intended. Furthermore, users should be trained to detect when the system is not working as intended.

Through Part 11 regulations, the FDA has paved the way to an electronic future for research sites.  Adopting a Part 11 system doesn’t take an act of faith but it does require a systematic approach to compliance.  If you want to see how other sites are ditching the paper regulatory binders and moving towards electronic freedom, visit our website to learn more about RealTime-eDOCS.  Better yet, contact us for an online demo to see the system in action!

24 Mar 2016
edocs RealTime-CTMS Clinical Trial Management Systems Software

4 Steps to Standardize and Centralize your Regulatory Binders

Clinical research sites typically conduct studies with multiple sponsors/CROs.  While this is great for generating revenue for the site, it can be a major challenge to manage regulatory documents across sponsors/CROs. Filing within regulatory binders across multiple studies tends to be inconsistent and very redundant.

Adding to this issue, paper-based processes associated with regulatory binders is inefficient and very time-consuming.  At smaller sites, investigators may struggle keeping up with regulatory filing and clinical research coordinators are forced to spend terrible amounts of time performing clerical tasks (e.g., completing paperwork, printing, filing, routing forms, collecting signatures, etc.).  Most research sites would agree that this time would be better spent recruiting study subjects and conducting study visits.

realtime edocs
Great processes and electronic systems can lead to greater efficiency.

As research sites grow in size, they typically establish dedicated regulatory specialists that remove much of the regulatory burden from research coordinators and investigators.  This is a great move for sites to make but this doesn’t solve the regulatory problem.  Instead of making the regulatory process more efficient, the workload is merely shifted to another team member.  This burden dramatically limits the amount of studies that a dedicated regulatory specialist can manage.

What if sites could streamline the regulatory process, allowing investigators and research coordinators more time to dedicate to the success of their studies while also providing regulatory specialists the ability to manage additional studies?  A simple remedy is to standardize and centralize regulatory processes across studies.  This can be achieved in four steps:

  1. Create a standard table of contents (TOC) for your binders and use it across studies. Having a standard TOC will create familiarity for your staff and make filing more efficient.
  2. Create a central filing system for training and qualification records. Instead of participating in redundant filing across studies, maintain one central location to include CVs, licenses, GCP training, and other general records.  Sponsor/CRO monitors can access this central location as needed during monitor visits.
  3. Create a standard operating procedure (SOP) outlining your new process and ensure that all of the site’s regulatory SOPs are standardized across studies. Yes, sites may receive pushback from some sponsors/CROs but SOPs help keep your new process running smoothly by providing the site more ground to stand on.  It’s important to articulate the site’s processes to your monitor in a way that is easy to understand.  Ultimately, this new process is a benefit to sponsors because it increases quality and efficiency at the site while allowing the study team more time to schedule and conduct study visits to meet recruitment timelines.
  4. Adopt an eRegulatory system to create efficiencies at a higher level. A site-centric eRegulatory system, such as RealTime-eDOCS, allows sites to dramatically reduce costs associated with paper, supplies, working hours, and physical archiving.  Using electronic signatures alone can save sites countless time routing documents and gathering signatures.  To take full advantage of an eRegulatory system, it’s important for sites to adopt the entire system and move as far as they can towards being completely electronic.

With standardized processes at the site-level combined with technology, the industry is moving towards increased quality and efficiency.  With this increase, sites have the opportunity to become streamlined while ensuring the long-term viability of their business, and sponsors/CROs continue to gain access to highly dependable research sites.

By: Nathan Levens, BS – eDOCS Product Manager, RealTime Software Solutions, LLC

24 Mar 2016
edocs RealTime-CTMS Clinical Trial Management Systems Software

RealTime-eDOCS™ – A Site-Centric eRegulatory Solution

Technology is shifting the clinical research industry towards electronic solutions that create efficiency while dramatically reducing costs. RealTime-eDOCS™ is the first eRegulatory solution fully integrated with a robust clinical trial management system (RealTime-CTMS™). It’s now easier than ever for sites to eliminate paper-based regulatory binders while managing regulatory documents from study startup to record archive.

Utilizing this eRegulatory solution allows sites to:

  • Save time and money by going paperless
  • Standardize and centralize eRegulatory binders in one secure location
  • Utilize a PET system (Professional Education Training) to manage and track personnel curriculum vitae, professional licenses and certifications
  • Increase efficiency by utilizing electronic signatures
  • Improve collaboration between investigators and sponsors

In addition to the benefits of this eRegulatory solution, CTMS-Integrated RealTime-eDOCS™ implements informed consent tracking for all subjects in a study. No more paper-based consent tracking logs!

Even sponsors and contract research organizations will benefit from a site-centric eRegulatory solution. Sites have the ability to grant remote access to monitors and sponsor contacts. Remote access will potentially reduce travel costs for sponsors while accelerating the process of updating trial master files.

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Go paperless with the first CTMS-Integrated eRegulatory solution and experience the benefits now. Visit our website at www.realtime-ctms.com or give us a call at (210) 852-4310.

RealTime Software Solutions, LLC is dedicated to creating innovative solutions by focusing on research sites. All of our products are built by obtaining valuable input from leading research sites around the nation. All RealTime staff have clinical research experience and understand the challenges of maintaining an efficient and productive research facility.

Call (210) 852-4310 to find out more.