Electronic Trial Master File

Electronic Trial Master File

Methods of Capturing the data  clinical trials.

Electronic Trial Master File (eTMF) solution is a clinical collaboration platform for managing the Data of Subject, Activity, Tracking, Maintaining, Archiving clinical trial documents. It allows life sciences companies to streamline processes, automate information exchange, and reduce the administrative overhead associated with running clinical trials.

What EDC Gives:

  • eTMF Process Management and Workflow of the Activity Wise Management
  • In an eTMF, documents are acquired electronically and stored electronically
  • Document Classified As like TMF, SMF, ISF Section
  • Having the Unique Document Identifiers as Metadata
  • Document Storage– At a minimum, your eTMF system should allow you to store documents
  • Customizable User Roles
  • QC of the Documents
  • 3 Stage Approval of the Document to Avoid the Error
  • Search the Documents
  • Electronic & Digital Signature Technology
  • Comprehensive Archiving & Retrieval
  • User-friendly interface and operating the software
  • No paper use will reduce the cost of paper and avoid the error also
  • Every User have individual access of computer system
  • Easy and Secure data and Access
  • Access for the proactive support from the technical team to set up the clinical trials

Benefits by using EDC:

  • Reduce business risk– systems provide confidence that you have met the regulatory compliance requirements
  • Enhanced artifact quality –automated systems have been proven to make fewer errors than manual paper handling processes; ability to implement automated quality control processes.
  • Improved team productivity – Sharing and viewing documents anytime, anywhere from any device is faster than manual paper retrieval.
  • Reduced auditing and reporting costs – Automated reporting and electronic retrieval of eTMF content can significantly reduce auditing and reporting labour and travel costs.
  • It is easy to set the New Structure Management
  • Handle the data of complex study easily
  • Secure access for individual user
  • Data Capture with high-Quality & Error free
  • Reduction of cost of human & Paper
  • Have the Access to the review of QC/QC to avoid the error during the submission
  • Design can be copied and Reused for the future project
  • 21 CFR Part 11 Compliance
  • Design As per the ICH-GCP E6

Regulatory compliant, multi-functional Clinical trials management software solution for CROs

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