eReg/eISF for Sponsors & CROs
eRegulatory Enterprise (formerly Complion) or eISF provides trial sponsors and CROs with innovative solutions for electronic Investigator Site Files (eISF) that centralize and streamline site compliance and inspection-readiness.
Access self-service monitoring and visibility with effective site collaboration.
Remote monitoring, decentralized trials, and remote ISF review as an option for any trial.
Activate sites to support their investigators anytime, anywhere, for inspection-ready regulatory and site files.
Remotely manage all stakeholders and documentation throughout the clinical trial life-cycle and clinical trial portfolio.
eISF That Sites Love
Increase adoption and efficiencies
Rapid startup & site adoption, without the need for additional study build. Create any type of study and ISF with documentation and automation templates.
Easily transition eISF control to any site, anywhere, with built-in training, validation, and support, and an option to function as a TMF or Site Portal for standardization.
Enable sites to qualify, initiate, and support investigators and study teams from any location in minutes with role-based automation of delegation, credentialing, training, and access to the most current protocol version, all from a mobile clinical portal.
Ensure sites maintain file organization with folders, keywords, and naming conventions that are always up to date.
Rapidly and accurately collect and prepare site documents with site collaboration and eTMF integration options to DIA, and other reference models, available out of the box.
Streamlined Collaboration, Enhanced Security
Activate and monitor investigators on demand
RealTime’s eReg/eISF solutions are Part 11, GCP, SOC2, HIPAA, and GDPR compliant.
Share documentation from your IRB, email, vendors, labs, facilities, sites, and more.
ISFs remain up to date with most current sponsor-provided documentation while eliminating redundant efforts for site document distribution.
