What is eRegulatory in Clinical Trials?
eRegulatory is an electronic version of the binder maintained at clinical trial sites manage regulatory documents created before, during, and after a clinical trial to comply with regulations associated with medical development. The eRegulatory platform is the crucial component of the Electronic Investigator Site File.
Virtual binder or electronic binder systems solve the challenges of digital compliance, physical document storage constraints at trial sites, and information sharing with sponsors and CROs.
A site-operated eRegulatory solution enables efficient sharing of essential regulatory documents between research sites and sponsors while remaining 21 CFR Part 11 compliance.
Utilizing an eRegulatory system significantly streamlines multicenter clinical trial management. As a result, coordinating centers gain communication and performance efficiencies across participating sites of all ongoing studies.
Leading academic research centers, clinical trial site networks, and independent sites are now harnessing the scalable capabilities of an integrated Electronic Investigator Site File (eISF) solution.
Research centers must build an Electronic Regulatory strategy to identify key project goals and generate requirements for core functionalities.
How eRegulatory Impacts Clinical Trial Management
The increasing complexity of clinical trials within the last decade has forced research sites to respond with new technology and regulatory processes. Clinical trial sites now deploy eRegulatory systems to streamline the management of the required regulatory documents.
Site-first eClinical solutions streamline workflows, reduce cost, lower compliance errors, and enable study scalability for all participating trial organizations.
In response to site and sponsor needs, software companies have built numerous platforms in the past decade. Clinical Research Professionals are now overwhelmed with the extensive amount of eClinical solutions on the market.
Decision-makers face the challenge of selecting software that streamlines operations while reducing negative organizational impact.
Terms to Consider
Understanding the ROI of eRegulatory is critical to make an informed decision.
Over 10,000 research teams managing eRegulatory on Florence eBinders™ have realized a significant return from moving to a site-first eRegulatory solution. The benefits appear in core categories, including increased team member specialization, more nimble operations, remote monitoring capabilities, increased efficiency, and a reduced risk of audit findings.
We compiled comprehensive data from these teams to build an ROI white-paper that explores six economic drivers for eRegulatory. This document extensively reviews the investment of an eRegulatory platform.
Accelerate Study Startup
A key driver of Research Sites making the move to an eISF is the acceleration of study startup time – with many sites seeing a reduction of more than 50% of their average startup time (one major NCI cancer center is now approaching an average of only 26 days from SIV to Ready for First Patient In).
- Single-click deployment of templated study binders across all research teams.
- Predefined placeholders for required documents coupled with due dates and team member assigned tasks to track performance.
- Automated workflows to route signature requests and completed documents to the appropriate people and places.
- Dashboards and reports to track all startup milestones across a single site, or a multisite study in a single place.
Strengthen Regulatory Compliance
Sites are reducing and even eliminating compliance risks related to document and data management with purpose-built eISF platforms.
- Automated audit trails track every view, change, update, and signature on each document and folder 24/7.
- Advanced permission controls ensure that only the approved individuals/teams can view, access, download, and edit files and folders.
- Expired document notifications alert admins and users of documents set to expire such as CVs and other study critical documents.
Streamline Multicenter Management
As multicenter studies continue to increase, the Coordinating Center must have as much oversight and access to their research sites as possible. Multisite studies from six sites to 200 sites are using Florence eISF.
- Standardize and distribute frequently used form templates with fillable fields to all sites.
- Granular role-based access controls allow the coordinating center to ensure each site only sees what they are supposed to see.
- Built-in quality control workflows allow centralized overview and collaboration before approving key documents.
- User-friendly site workspace available anywhere on multiple devices gives sites the tools they need to get work done.
Eliminate Shadow Files
Directly integrating source documents into the eISF platform eliminates the need for shadow files and duplicate processes that ensure SDV is always compliant, secure, and possible.
- Integrate the eISF directly with the EHR/EMR to securely route subject, visit and date directly into the appropriate file/folder/study on the eISF platform.
- Use eSource Tablet or Computer interfaces to directly input source document data into the eISF.
Enable Remote Access
Moving to a unified digital ecosystem for managing all study-related documents and data opens up the possibility of remote access and monitoring.
- Advanced permission controls ensure monitors only see what they are supposed to see, and when they are supposed to see