Electronic Investigator Site File (eISF) for Clinical trials Software in Bangalore, India, USA & Europe
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Electronic Investigator Site File (eISF)

Clinevo electronic Investigator Site File (eISF) is a cloud based, easy-to-use and highly secured electronic document management platform for investigator sites involved in the clinical trial for full control over their investigator site files (ISF).


Clinevo electronic Investigator Site File (eISF) meets regulatory guidelines including:

  • Digital content archiving,
  • Security and access control, 
  • Change controls, 
  • Audit trails, and 
  • System validation. 
Image

Image Configurable ISF Structure 

  • Clinevo electronic Investigator Site File (eISF) system comes with a pre-built eISF reference model & also allows organizations to define their own / Study / Site specific ISF structure

Image File Planning & Milestones Setup

  • The Clinevo electronic Investigator Site File (eISF) system allows companies to create a File Plan along with milestones at the study / site level

Image Live Tracking of Missing Documents

  • Based on the file plan, Clinevo electronic Investigator Site File (eISF) system tracks the status of the documents & monitors the ISF compliance at every level.

Image Document Lifecycle and Version Control

  • Clinevo electronic Investigator Site File (eISF) software has a robust document lifecycle with Author, Review, eSign/Approval workflow & Automated version controlling with robust Check-in and Check-out functionality

Image Advanced Analytics

  • Clinevo electronic Investigator Site File (eISF) System provides advanced analytics to track Completeness, Quality, Timeliness and TMF compliance of a study.

Image Bulk / Quick upload

  • Clinevo electronic Investigator Site File (eISF) System allows users to upload hundreds of documents in one go using a simple drag and drop & provides dynamic indexing options for documents

Image Integration with eTMF

  • Clinevo electronic Investigator Site File (eISF) software can be integrated with the eTMF systems to automatically file selected documents into eTMF

Image Sharing and Collaboration

  • Clinevo electronic Investigator Site File (eISF) software allows a user to invite external parties to upload and work collaboratively on documents in a controlled manner

Image Faster User Adoption

  • Site personnel, investigators and others can be trained on Clinevo electronic Investigator Site File (eISF) system within few hours.

Image Anytime, Anywhere & Any device

  • Clinevo electronic Investigator Site File (eISF) software is a user-friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers

Image Regulatory Inspection Ready

  • Clinevo electronic Investigator Site File (eISF) system complies with DIA, 21 CFR Part 11, ANNEX 11, GxP and GDPR guidelines

Image Extendable Document Management

  • Clinevo electronic Investigator Site File (eISF) software can be used as a focused eISF or as a general document management system for a clinical trial

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 INDIA : +91- 44 6645 5983

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