Electronic Trial Master File

Our eTMF Success Process


ANALYZE CURRENT DOCUMENTS AND PROCESSES

DEVELOP A CUSTOM PLAN FOR eTMF DEPLOYMENT

DEPLOY A REAL-TIME, CENTRALIZED APPROACH

STREAMLINE UPLOADS, MANAGEMENT, AND OWNERSHIP

PROVIDE ONGOING METRICS, REPORTS, AND UPDATES

Your Electronic Trial Master File (eTMF) houses the most important output of your clinical trial.

Don’t put your eTMF at risk by using under-qualified or poorly resourced groups utilizing obsolete, inefficient, and imprecise document management practices.

Relying on the quality, experience, and dedication of our people, inSeption Group will provide you an integrated, dependable, accurate, and customized worry-free program.

Our model combines the depth and experience level of our people with effective tools and processes already in place that are designed to ensure your critical eTMF documents and content are secure, organized, readily accessible, and always in complete compliance with all relevant regulations.

If you would benefit from “one less thing to worry about,” allow inSeption to provide you a solution that has repeatedly revealed operational and cost efficiencies for clinical document management. Among our full suite of solutions, our Electronic Trial Master File (eTMF) management service ensures files are accessible in real-time and inspection-ready.

Among our full suite of solutions, our Electronic Trial Master File (eTMF) management service ensures files are accessible in real-time and inspection-ready.

  • We take a fresh and modern approach to eTMF management
  • We give you real-time access to your inspection- ready eTMF
  • We are an experienced team of skilled and passionate people
  • We maximize operational and cost efficiencies

The inSeption Group can help you:

  • Assist in developing a strategy for the implementation of an eTMF
  • Assist with deployment and application of any eTMF
  • Provide experienced staff to guide the process and act as document managers
  • Manage Document Migration
  • Manage, create, and develop a TMF Plan, user dashboards, reports, and related metrics
  • Perform routine QC on the TMF on a basis as determined by the client (typically quarterly)
  • Ensure continuous client access to their documents from project start
  • Manage the eTMF lifecycle by effective planning, efficient collection, and continuous quality oversight
  • Monitor and understand the health of the TMF in real time

Ready for a worry-free eTMF management program? Contact us.

DAWN NICCUM

267.401.1546 | dniccum@inseptiongroup.com

JOSEPH ARCANGELO

267.498.5092 | jarcangelo@inseptiongroup.com