Electronic Investigative Site files (eISF)
Managing the investigative site files (ISFs) has traditionally been a labor-intensive, paper-based, manual process for sites, sponsors and CROs. Study managers and CRAs who visit the investigative sites spend a considerable amount of time to keep this documentation current, complete, accurate, and available upon requests during monitor, auditor, and regulatory authority site visits.
The Trial Interactive eISF offers a complete solution for electronic distribution, collection and management of essential investigator site files. The eISF allows the investigative site personnel to organize their regulatory and study documents using the file structure that is currently in place while maintaining full control over their documentation. Our integrated platform enables seamless collaboration and document exchange between sponsor and site, supports remote monitor site visits and facilitates document review and approval by the trial sponsor, reducing the time needed for site activation and ongoing site visits. Security allows site personnel to control access to folders and documents, even preventing access to blinded folders that may contain subject information that meet the HIPAA requirements. No more paper regulatory binders, no more paper, no more duplication of work. Contact TransPerfect to hear how we can move your studies and sites into the eISF world.