ETMF Review

We help ensure you have a fully compliant electronic trial master file (eTMF) system in a number of ways. The first is by helping you to conduct a full gap analysis of your eTMF environment. We meet with key stakeholders to understand the scope of your eTMF environment, your needs, and to clearly define the scope of our review. We can help you identify applicable regulatory requirements, or we can conduct a more robust review of the eTMF from both a regulatory and business best practice perspective.

Once we have clearly defined the scope of our work, our regulatory expert works with your key stakeholders to develop an inventory of specific items that need to be evaluated throughout your eTMF. Focusing on all of the critical areas enables our team to review your eTMF documents as quickly and efficiently as possible.. Upon completion of this phase of the project we deliver a Review Guide, which includes a custom scorecard, instructions for how the reviews will be conducted, and a tracker that can be used to report compliance percentages up to leadership.

Once the Review Guide has been accepted by the key stakeholders and the scope of required review determined, we assemble a team of experienced eTMF reviewers with relevant regulatory knowledge to conduct a detailed review of all in-scope documents within your eTMF system. Upon completion of the review, we will document the results of our assessment and develop a detailed summary analysis of our findings. We can provide you with support to remediate your eTMF based on these findings, should that additional support be needed.

As part of your ongoing inspection readiness, LSM can also help you develop a system of eTMF spot checks to support your compliance on a broader scale. We can help you develop a cadence of check-in meetings, scope and process design, and remediation processes to enable you to continuously ensure that your eTMF is organized in compliance with applicable regulations and protocol guidelines.

CASE STUDY

 

A pharmaceutical company asked us to do an in-depth review of a specific and large scale eTMF. In order to offer an accurate estimated timeline and budget, we initiated a pilot review that included all the studies from one country (the entire eTMF project encompassed many sites in multiple countries all over the world). 

 

Upon reviewing the site-level documentation, we developed a Review Guide which included a scorecard aligned to the regulatory guidelines, as well as criteria to be used to objectively assess how well each site met the guidelines. 

Based on the time it took to review the studies in the pilot, we were able to accurately project how long it would take to complete the project within the somewhat aggressive requested time frame of 6 weeks. We assembled a team of 9 reviewers, including a Senior Regulatory Analyst and a dedicated Project Manager, and successfully completed the project on time and under budget. We provided the client a comprehensive summary report, including overall trends in compliance with regulations and the percentage of compliance by country and by site, supporting the company’s ability to remediate as needed, e.g., retraining specific investigators, as needed. 

LSM Consulting is a safety and training consultancy working in the pharmaceutical and medical device sectors. It has been operating in the United States serving international clientele since 2008.

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