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Dorchester Center, MA 02124
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Monday to Friday: 7AM - 7PM
Weekend: 10AM - 5PM
eTMF Support
eTMF Support Services
GLORAMP Pharma Consulting Ltd provides comprehensive eTMF (electronic Trial Master File) support to ensure your clinical documentation remains compliant, inspection-ready, and aligned with ICH E6 (GCP) and EMA/FDA regulatory expectations.
Our team combines regulatory and quality expertise to help sponsors, CROs, and emerging biotechs implement, maintain, and audit eTMF systems efficiently — ensuring every essential document is traceable, complete, and version-controlled.
Process & SOP Development
Drafting or updating TMF-related Standard Operating Procedures (SOPs), Work Instructions, and role definitions (TMF Manager, Clinical Lead, CRA, Archivist, etc.) to align with inspection readiness standards.
Ongoing eTMF Maintenance & Oversight
Supporting document QC, completeness checks, and periodic reconciliation between sponsor and CRO TMFs to maintain an up-to-date and accurate TMF at all times.
TMF Quality Review & Gap Analysis
Conducting targeted or full-scope TMF Quality Reviews to identify missing, misfiled, or duplicate documents, helping you achieve the “Inspection Ready TMF” status.
Book a free call
Let’s talk! Book a free 30-minute call with a senior team member to explore how we can support your goals.