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How does the pandemic changed the way we prepare for TMF inspections, and how do we address the new challenges remote inspections could bring?

Medical literature review at a local level has always been a challenge. Is technology the answer to simplifying the process?

The beginning of November saw the launch of version 3.2.0 of the TMF Reference Model. The updates align with current regulatory guidance and industry best practices, making it easier to organize the TMF Reference Model to suit a company¡¯s own processes.

While all TMF documents are important, some are more crucial to a trial than others. At the core of these are the essential documents, as defined by ICH Guideline for Good Clinical Practice, E6, Section 8, ¡°those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.¡±

Join ¾ÅÉ«'s discussion with industry experts from Pfizer, Bayer, CodaMetrix, Biogen, BI, Novartis, and Syneos Health about how AI is accelerating changes in the life sciences industry and ways they are leveraging data to support their teams, studies, and products. 

Anyone around in the ¡¯80s remembers the TV sitcom Who¡¯s The Boss? We would sit around Tuesday nights to see Tony Micelli (played by Tony Danza) and Angela (Judith Light) raise their blended family and keep us on the edge of our seats wondering will they or won¡¯t they end up together. 

As the world closed its doors to human interaction earlier this year, our digital platforms like social media, electronic patient data capture technologies, and wearable sensors were put to the test.

What is an eTMF? eTMF stands for electronic trial master file. It is the all-important trial master file in a digital format.

Whether by choice or by force, when things change and those changes make things simpler, they tend to stick. I firmly believe that on the other side of our current global challenges with COVID-19, many of the changes made by regulatory bodies, sponsors, CROs, and sites will be here to stay.

When an English source requires a revision after translations have begun, this can be a major challenge in maintaining set budgets and timelines in global COA clinical trials. Often, these revisions seem minor but can end up having a significant impact on the multiple languages in scope for a study.

Inspection readiness refers to the ability of an organization to operate at a level that allows for effective preparation for an inspection. , a TMF inspection focuses on the documents and records related to the clinical trial versus an audit that encompasses the activities related to the trial (Sec. 1.29, 1.6).