Last week, Clinical Conductor CTMS hosted a webinar with Rick Arlow, CEO of Complion to discuss best practices for regulatory and document management. He discussed the issues with maintaining paper documentation and how using a document management system can aid research sites in their regulatory management process.
The webinar began by discussing the problems with using physical documents at a research site. Keeping physical binders and folders is cumbersome and can take up space at your site, while maintaining the structure of these binders is a complicated process. Rick gave examples of customers who used to have whole rooms devoted to storing paper documents and running out of space to keep the important files they need to run their trials efficiently. Rick stated that since you cannot easily edit these documents when revisions need to be made, more copies are created leading to even greater confusion. Rick also discussed the problems that can arise from keeping all your documents on a shared drive on your research sites servers. Long file names, multiple folders within folders, and then uploading those documents to a CTMS or another service still involves maintaining those documents in multiple locations. Another problem with maintaining physical documents is having to train rotating staff members on that specific research sites document management process. Ensuring that the proper training has been completed adds another layer of difficulty to the document management process.
So, what does a regulatory and document management system look like? This type of system would contain all core documents and processes. Key team members would have the ability to access documents that they need and complete tasks all within the same system. On the regulatory side, this would involve continuing the training and oversite of all key members, while maintaining the regulatory binder in one spot. Once the key documents have been collected in the regulatory and document management system, users can review, track and sign off on agreements and contract. All records and key components for patient’s safety can be kept within the system or compliment an EMR or other solution currently being used.
When a research site implements a regulatory and document management system, it provides value to that organization. Rick discussed how it engages staff, accelerates growth, and delights sponsors by providing secure and remote access. Implementing the system will also improve visibility and compliance while driving the reputation of your organization. Research sites will also be able to save money when they begin to use a document management system. Citing a CenterWatch-Complion study from 2015, Rick discussed the savings research sites can save when they start to use a document management system. According to the study, per study a research site could save up to $6,200. This results in a 40% reduction in staff time costs, and a 100% reduction in material costs.
In closing, Rick went over the benefits for integrating a regulatory and document system at an organization, including Part 11 Compliant and Auditable, single login for staff across system, eSignatures and bidirectional real time flow of document and data.
Interested in learning more best practices for regulatory and document management? Click here to listen to the entire webinar featuring Rick Arlow of Complion.