Download: Competitive Advantages and Trends in Site Access to the eTMF

Understand the trends in site access to the sponsor electronic trial master file (eTMF) and how new technology innovations are adding competitive advantages for sponsors who harness this industry advancement.

The standard method of exchanging critical study documents with trial sites via traditional methods of site visits, email, paper, and one-way site portals is poorly equipped to handle the rising complexity and compliance requirements of today’s clinical trials.

In response to this challenge, leading sponsors are pursuing a strategy of enabling direct site access to their electronic Trial Master File (eTMF) by deploying a fully functioning electronic Investigator Site File (eISF) at their study sites.

Sponsors must understand and be prepared for this advancement by shifting their mindset from thinking of the eTMF as a passive document repository, and instead adopt an Active eTMF posture within their trial site operations.

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Relying on an eTMF as simply a passive document repository (Passive eTMF) will leave sponsors and CROs blind to site compliance risks, study performance bottlenecks, and delayed studies.