By Betsy Fallen, Regulatory & Clinical Process Consultant, BAFallen Consulting, LLC and Rick Arlow, Founder & CEO of Complion, Inc.
What Is Driving The Preference For Digital Documents?
The obvious answer to this question is money. We've all heard how much it costs to courier documents, fax paper, and save paper. Beyond that, there are significant costs associated with meeting requirements for extended retention.
For example, Medicines and Healthcare products Regulatory Agency (MHRA) regulations now require 25-year retention of documentation to support clinical trials. Keeping paper for that long is not only unwieldly, it's very expensive. But clinical research organizations are powerfully drawn to digital documentation for reasons beyond the potential for cost reduction. Consequently, the mere business of clinical research has changed.
We're all more global. We're all working with remote partners. We don't always work in an office everyday as we used to. The ability to work remotely has transformed the business. In addition, supportive standard and regulations are further driving the industry toward digital document.
This paper presents insight and expertise on how investigative sites can begin the transformation to digital documents, including concrete, practical suggestions for eliminating the inefficiencies inherent in printing, storing, and managing paper documents. For clinical site staff, educating themselves before the adoption or purchase of regulated content repositories is key to making the best decisions and driving their success, including improved patient experiences.