By Blake Adams
The electronic master file (eTMF) is essential to submit a clinical trial to regulatory agencies. As part of clinical operations' active management, the eTMF gives sponsors real-time visibility into quality, timeliness, and completeness across their studies.
Biotech companies starting their first few clinical trials typically do not have the resources to host an eTMF in-house. For this reason, they often outsource to a Clinical Research Organization (CRO) and use the CRO’s applicable software. But, Good Clinical Practice (GCP) mandates that the sponsor is responsible for clinical operations, no matter how much they subcontract to a CRO.
When outsourcing the eTMF to a CRO, the standard operating procedures (SOPs) of a CRO often restrict the sponsor's external access to the system, resulting in lengthy delays and ultimately a long-term risk for the sponsor.
If the study is successful and moves to subsequent phases, or if Biotech adds new studies to their portfolio, hosting the eTMF with subcontractors limits the Biotech from moving operations in-house or engaging new CROs. Additionally, the sponsor now has to work with various eTMF platforms across their numerous studies.
Continue reading to learn more reasons why Biotech companies are bringing their eTMF in house even if they outsource services to subcontractors.