Focus on your trial. We’ll handle the TMF.
We help CROs, sponsors, and biotech companies maintain audit-ready TMFs from start-up to close-out — without the delays, rework, or compliance headaches.
What We Do
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Full TMF Management – From document creation to final archiving, we handle the details so you don’t have to.
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TMF Oversight & QC – We monitor completeness, accuracy, and timeliness across the life of your trial.
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Process Optimization – We streamline workflows and implement best practices for smoother, faster filing.
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Vendor Alignment – We coordinate across teams, CROs, and systems to keep everything in sync.
Why Granular Level?
Founded by Nicole Palmer, MS, a clinical research expert with over a decade of hands-on TMF experience, we understand the stakes. Regulatory inspections can make or break a trial and your TMF is the first thing they look at.
We bring:
✔ Deep regulatory knowledge (ICH-GCP E6 R3, EMA, FDA)
✔ Proven methods for creating inspection-ready TMFs
✔ A partner mindset, we work as an extension of your team
Let’s Keep Your TMF Audit-Ready
Whether you need full-service TMF management or targeted oversight, we’ll make sure your study documentation is always inspection-ready.
Join the TMF Club
What do you get? Twice a month you’ll get emails loaded with the latest TMF trends and tips.