TMF Management Services include:

Our team specializes in providing a unique approach to full service TMF management. We host a fully, validated eTMF Management System and processes, in our environment, utilizing our training, SOPs, Work Instructions, and consultants to manage it all so you don't have too. And when you're ready to move the eTMF Management system into your environment, we're there to guide you through the painless transition.

Consistent Standards

       We focus on looking across the activities during the products lifecycle to ensure data flows freely and efficiently across your organization, using a compliant and consistent standard.

TMF Inspection Readiness Lifecycle

Phase 1: TMF Analysis

The Analysis and Preparation Phase begins with documenting the current state of your organization's TMFs, the future desired state, and a roadmap of what it will take to achieve your goals.

  • System Wellness Check
  • Initial TMF Correctness Review
  • Recommended TMF Plan

Phase 2: TMF Management Process Implementation

To become inspection-ready, the TMF Management Process Implementation Phase implements the activities outlined in the roadmap.

  • Perform mapping, filing, scanning, Qcing, etc.
  • Create SOP’s, Add eTMF process in study plans (monitor plans, PM & Communication plan, etc.

Phase 3: TMF Finalization

The TMF Finalization Phase conducts final risk-based correctness and completeness checks to ensure inspection readiness and provide final recommendations.

  • Final completeness and correctness review, finalizing all docs/plans
  • Final recommendations

Phase 4: TMF Mock Audit

The TMF Mock Audit Phase is conducted to ensure you know what you have and where you stand. Testing and controlling various scenarios, scaling, and costs will be our focus to assist your organization in maintaining IR.

  • List of current process issues
  • List of gaps in documentation 
  • List of any compliance concerns

Phase 5: TMF Audit/Inspection Support

The TMF Audit/Inspection Support Phase assists our clients with on-demand, comprehensive inspection support in the event of agency inspections and partner audits.

Workflow on how inspection will be conducted and written procedure for document reconciliation and retrieval

  • Pre-inspection TMF document staging
  • Pre-inspection process training 
  • Daily transcription of inspection 
  • Post-inspection report and recommendations
  • Post-inspection reconciliation re-filling of TMF documentation