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.
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
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