The Solutions We Deliver
From audit readiness to customized TMF solutions, we take the complexity out of your Trial Master File management.
TMF Health Checks
Conduct in-depth, periodic assessments of the TMF to ensure it’s compliant, audit-ready, and free from quality gaps. We offer custom reports highlighting risk areas, missing documents, or incomplete metadata and providing actionable recommendations.
Document Upload and Indexing Services
We provide hands-on services where your team assists with uploading, classifying, and indexing documents in the TMF according to regulatory requirements. This saves clients time and ensures accurate, consistent document placement within the eTMF structure.
TMF Reconciliation
Offer TMF-to-CRF (Case Report Forms) reconciliation or TMF-to-ISF (Investigator Site File) reconciliation to ensure consistency between the central TMF and the site files. This can be a time-consuming task that clients would appreciate outsourcing to a dedicated service.
Audit-Ready Prep and Mock Inspections
Prepare the TMF for audits by performing detailed pre-audit reviews. We offer mock regulatory inspections, walking clients through potential findings and helping them fix any issues before the actual inspection occurs.
TMF Migration Services
Granular Level assists clients in migrating documents from one eTMF platform to another while ensuring data integrity, compliance, and seamless organization. This could include validation of document completeness, metadata alignment, and gap analysis during migration.
Custom TMF Training for Teams
Provide tailored training sessions for client teams on best practices in TMF management, regulatory compliance, and how to maintain an audit-ready state. These sessions could be delivered virtually or on-demand via a learning platform.
Regulatory Submission Support
Offer support services for preparing documents for regulatory submissions. This could include ensuring that submission documents are correctly tagged, formatted, and organized within the TMF to meet specific regulatory requirements, such as for FDA or EMA submissions.
GCP and Regulatory Compliance Audits
Offer specialized audits focused on Good Clinical Practice (GCP) compliance, ensuring that the TMF aligns with regulatory standards like ICH E6(R3), FDA 21 CFR Part 11, and EMA’s eTMF guidelines. Detailed reports and remediation strategies are provided.
Metadata Optimization and Cleanup
Review and clean up the metadata associated with TMF documents to ensure consistency and accuracy. This can be critical for long-term TMF health, as poorly indexed metadata can make finding documents difficult and pose risks during audits.
Post-Audit Corrective Actions and Documentation Remediation
If an audit or inspection results in findings related to TMF gaps or inconsistencies, we offer a post-audit corrective action plan. This service could include fixing documentation issues, addressing regulatory findings, and implementing processes to prevent future non-compliance.