Electronic Trial Master File

Our Expertise

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Plan and Index
Plan and Index

We create a specific TMF plan and Index according to protocol and regulatory requirements. Our team has great knowledge and experience of various TMF reference models including the DIA structure.
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Management
Management

We can also manage the TMF for your study. We take care of document creation, collection, and review of the documents. We reconcile the ISF content against the TMF content and record the required metadata.
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Audit Readiness
Audit Readiness

We ensure that the TMF is always audit ready by undertaking regular completion checks based on the stage of the study. Our teams also conduct the regular and periodic QC checks to ensure compliance.

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