From manual to electronic: Taking the pain out of the trial master file processes

by William Hamilton

Life sciences companies have long struggled with inefficiencies and inconsistencies with their trial master file (TMF) processes. Certainly, manual TMF processes leave many gaps and make it difficult for companies to maintain their clinical documentation sets, but this problem is not exclusive to manual processes. Even companies that have partially or completely adopted electronic TMF (eTMF) processes often still struggle with the same issues over how to plan and track their TMF.

Lack of process harmonization among different regional teams around the world is perhaps one of the most common issues global life sciences companies face. These differences in a labor-intensive and manual process can lead to situations that require corrective actions, rework and remediation.  For example, during an inspection, process inconsistencies could make it difficult to ensure easy document retrieval. This could lengthen the time of the inspection, require an investment of additional resources to track down documents, and probably lead to an inspection finding.

Having a single, harmonized eTMF process promotes greater productivity for teams around the globe. A truly efficient process requires standardization and the ability to plan effectively. With clinical trials, plenty of documents need to be handled, so having a process where those records are properly managed as they are received, as well as having a way to determine when records are expected, provides greater oversight.

It’s also important to be able to track records electronically, including the receipt and quality control (QC) results of those records, and to have quality metrics to support decision making. These tracking capabilities would not only provide insight into when records have been received but would also indicate whether they have failed or passed the quality checks.

Benefits of eTMF harmonization

There are many reasons why companies should be adopting eTMF and harmonizing their processes, but some of the clear benefits include inspection readiness, submission readiness, efficiency, improved quality and better oversight.

Being inspection-ready at every stage of the trial allows you to defend any actions or planning, so when inspectors ask questions, you’re able to quickly provide them with what they need.

As clinical documentation is received, the objective is to prepare these records for submissions. The records can be included in the submission package to the relevant regulatory authority, and if that documentation set is well-maintained from the outset, you’ll be able to get the regulatory team involved earlier in the process.

Having a single standardized eTMF process contributes to improved quality control. As study content is uploaded for processing, the system prevents users from bypassing the QC step before the records get to the final approval stage. Another benefit of a harmonized eTMF process is better governance through the generation of metrics and reports as records are received.

Overall, a standardized eTMF process eliminates time-consuming and costly manual processes, which leads to improved trial operational efficiency and quality.

William Hamilton is a senior product integrator with over twenty years of experience in the life sciences industry. He has been involved with custom and enterprise content management systems for multiple verticals exclusively for the pharmaceutical industry.  Working primarily in a technical capacity, he has participated in all phases of software development such as application design and development, testing, delivery, requirement gathering, and end user training.


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