eISF for Sponsors & CROs
Complion provides trial sponsors and CROs with innovative solutions for electronic Investigator Site Files (eISF) that delivers a perpetual state of site compliance, inspection-readiness, and allows:
- Project teams to access self-service monitoring and visibility with effective site collaboration
- Remote monitoring, decentralized trials, and remote ISF review as an option for any trial
- Sites to activate and support their investigators any time, anywhere, and maintain inspection-ready regulatory or site files to your expectations
ISF Connect Automates Compliance
ISF Connect helps remotely manage all stakeholders and documentation throughout the clinical trial
life-cycle and your clinical trial portfolio.
Rapid startup & site adoption
Without the need for additional study build, create any type of study and ISF with documentation and automation templates. Rapidly transition eISF control to any site anywhere with built-in training, validation, and support, with an option to provide as a TMF or Site Portal for standardization.
Sites activate investigators
In startup and through study conduct, 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 available from a mobile clinical portal.
Sites always monitor-ready
Enable sites to meet your expectations to maintain file organization with folders, keywords, and naming conventions that are always up to date with ISF Connect. Share documentation from your IRB, email, vendors, labs, facilities, sites, and more. Ensure accurate completion of regulatory requirements with purpose-built workflows for delegation of responsibilities, safety letters, living logs, training, eSignatures, and more.
TMF prep & site doc distribution
Enable project teams to rapidly and accurately collect and prepare site documents with effective site collaboration and eTMF integration options to DIA and other reference models available out of the box. Ensure ISFs remain up to date on most current sponsor-provided documentation while eliminating redundant efforts for site document distribution with ISF Connect.
Self-service monitoring
Monitor on demand with role-based access by SOP, including for remote view-only source data review and verification, with tools for site collaboration and self-service search following your standard conventions on every trial and site.
Ready to get started? Request a Demo
Ready to get started? Request a Demo
Proof of concept Headline Here
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Trust in Our Expertise & Focus
As the founder of the eReg market, we provide unmatched value and site-regulatory expertise, and we enable rapid and full adoption. As a best-of-breed provider, we can rapidly integrate across the ecosystem to all major site CTMS vendors, major cIRB / shared site platforms, and many sponsor / CRO solutions.