Over 75% of clinical trial sites who have not yet adopted eRegulatory plan to do so in 2019.
Why? In addition to growing industry pressure from sponsors who expect a digital site infrastructure, trial sites with eRegulatory platforms are introducing key advantages over those sites without eReg.
What are those advantages?
Eliminate Paper Binders
Move away from paper-based files. Manage & store regulatory, source, business and all other clinical research documentation fully electronic in a 21 CFR Part 11 compliant system.
Multicenter Management
Easily coordinate multicenter studies with a secure centralized study collaboration workspace. Built-in quality control workflows allow centralized overview and collaboration before approving key documents. Granular role-based access controls allow the coordinating center to ensure each site only sees what they are supposed to see. Global study dashboards and reports provide real-time insight into the study status across all trial sites.
Get Time back in your day
Eliminate redundant workflows and bottlenecks to reduce time spent on document management by up to 40%. Shifting to a “work from anywhere” platform allows Investigators and other trial staff to manage binders, review files, and sign documents wherever they are securely on any device.
Free up space + Save money
Stop wasting valuable space filled with shelves of regulatory and source binders and eliminate off-site storage of long term study files. Moving to a secure, Part-11 compliant, cloud-based eRegulatory and eSource platform introduces long-term savings by freeing up space and eliminating storage costs.
Remote monitoring
Enable compliant, secure, and permission controlled remote monitor access. Clinical trial sponsors, CROs, and IRBs can be granted secure access to your investigator site files – seeing only what you want them to see when you want them to see it. Full audit trails capture a monitor’s actions while navigating your study binder.