CS-eTRIAL

Electronic Trial Master File (eTMF)

Electronic Investigator Site File (eISF)

CS- eTrials is an configurable electronic trial master and remote monitoring platform in electronic (digital content) format for organizing and storing, verifying and reviewing documents, images, and other digital content of clinical trials.

Electronic Trial Master File (eTMF) has inbuilt DIA reference model and meets regulatory guidelines including:

  • Digital Content Archiving, 

  • Security and Access Control, 

  • Change Controls, 

  • Audit Trails and

  • System Validation

Electronic Investigator Site File (eISF)

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).

 

Electronic Investigator Site File (eISF) meets regulatory

guidelines including:

  • Digital content archiving,

  • Security and access control, 

  • Change controls, 

  • Audit trails, and 

  • System validation. 

Electronic Investigator Site File (eISF)

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).

External Systems Integration

  • Electronic Trial Master File (eTMF) software can be Integrated with CDMS/ CTMS systems to get the study, site, patient and other information and dynamically create Directory structure.

 

Sharing and Collaboration

  • Electronic Trial Master File (eTMF) System allows users to invite external parties to upload and work collaboratively on documents in a controlled method

 

Faster User Adoption

  • Business TeamS, CROs, Site personnel, External Vendors and others can be trained on the electronic Trial Master File (eTMF) System within few hours

 

 Anytime, Anywhere & Any device

  • Electronic Trial Master File (eTMF) System is a user friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers.

 Regulatory Inspection Ready

  • Electronic Trial Master File (eTMF) System complies with DIA, 21 CFR Part 11, ANNEX 11, GxP and GDPR guidelines.

 

Extendable Document Management System

  • Electronic Trial Master File (eTMF) System can be used as a focused eTMF or as a general document management system for the clinical trials.

 Inbuilt & Configurable DIA TMF Structure 

  • Electronic Trial Master File (eTMF) software comes with a prebuilt DIA reference model & also allows organizations to define their own / Sponsor specific TMF structure

 

File Planning & Milestones Setup

  • Electronic Trial Master File (eTMF) software allows companies to create a File /Study Plan along with milestones at the study level, country level, and site level.​

 

Live Tracking of Missing Documents

  • Based on the file plan, electronic trial master file (eTMF) system tracks the status of the documents & monitors the TMF compliance at every level.

 

 Document Lifecycle and Version Control

  • Electronic Trial Master File (eTMF) software has a robust document lifecycle with Author, Review, eSign/Approval workflow & Automated version controlling with robust Check-in and Check-out functionality

 

 Advanced Analytics

  • Electronic Trial Master File (eTMF) System provides advanced analytics to track Completeness, Quality, Timeliness and TMF compliance of a study.

 

 Bulk / Quick upload with Dynamic Indexing

  • Electronic Trial Master File (eTMF) System allows users to upload hundreds of documents in one go using a simple drag and drop & provides dynamic indexing options for documents