Let’s face it, we have a paper problem.
In a recent webinar, RealTime’s CEO, Rick Greenfield spoke about the existing “paper problem” in the clinical research industry and ways that we can overcome it to achieve “Paperless Nirvana”.
As you already know, the Clinical Research Process primarily functions off of paper source documentation and manually transcribed data into EDC systems. Paper has been the standard for source documentation and regulatory processes for years, but these systems are far from efficient and change is overdue.
The Paper Problem
Using paper to conduct your research processes puts your site at a higher risk of inefficiencies and inaccuracies. This may happen as a result of:
- Delay in data receipt and review by the Sponsor or CRO.
- Time and travel expenses of on-site review of source and regulatory documentation.
- High probability of transcription errors from paper source to EDC.
- Data concerns: Punctual, Accurate, Complete, True.
- Increased opportunities for poor clinical practices, delayed investigator oversite and fraud.
- Coordinators and staff chasing doctors for wet-ink signatures.
- Paper-based central files such as staff professional documents (i.e., Licenses, CVs, Certifications, Training Trackers), temperature logs, equipment calibration records are all kept in paper files and must be maintained.
- Separate reminders must also be maintained to ensure that records are kept up-to-date and don’t expire.
- Regulatory filing into three-ring binders.
- Extensive office space requirements to hold bookshelves full of study patient charts and other study files can become very costly, not to mention the cost of efficient printer/copy machines and supplies.
- Long-term storage requirements of paper files (typically 15+ years).
- Paper records run the risk of getting damaged or lost.
- Redundant electronic, non-Part 11 compliant, storage systems to store document copies and drafts.
In addition to causing inaccuracies, paper processes increase the risk of fraud such as data and signature forgery.
Although all these problems have existed for years, adopting a paperless process is not as simple as it sounds, because like any other process in the clinical research industry, paperless platforms have to comply with FDA regulations, accepted eSignature processes, HIPAA and HITECH regulations and more. Building and adopting these compliant systems requires a concerted effort and time to complete.
Additionally, overcoming the natural resistance to change that may come from sites, sponsors and CRO alike can create even further challenges to the adoption of these new systems.
Change is not easy, but it is necessary. Advancements in technology and newly adopted customer-centric approaches are making it possible for companies to build software that will improve the workflows that are beneficial for all parties (Sponsors, Sites, CROs, IRBs and the FDA).
With systems such as eSOURCE, eREGULATORY, ePAYMENT, eCONSENT, automated data transfer to EDC, electronic drug accountability and lab kit tracking and portal monitoring for all types of reviewers, we are one step closer to achieving paperless nirvana.
If all technologies are adopted by sites around the country and the world, data will flow faster than ever, data quality will improve, site efficiency will be accelerated, data and regulatory review will be accomplished in real time and we will see sites and studies go completely paperless.
At RealTime, we believe that the customer’s needs come first. That’s why all our solutions have been created with extensive research and support from sites, Sponsors and CROs around the world.
We focus on efficiency, super customer service and helping our clients from study-start to finish. As part of the paperless nirvana initiative, RealTime has created solutions that communicate with each other and will help each site customize them to their specific needs.
For more information about how to achieve paperless nirvana at your site, call (210) 852-4310 or text PAPERLESS to 74-121. To view all our solutions and S.O.M.S click HERE.