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.
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.
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.