Clinical operations breakfast: eTMF at Alnylam

Every life science company faces two basic dilemmas as they move through clinical development creating the story of the program for future scrutiny: 1) to eTMF or not to eTMF, and 2) to outsource oversight for the Trial Master File to a CRO or spend internal resources on management?

The life of a virtual clinical trial participant

I am currently participating in a clinical trial. I have neither seen a physician nor traveled to a site for a procedure. During my first 15 days of trial participation, my samples have been sent 43 times - and I never once had to leave my house for it.

Artificial Intelligence in Medicine: Hope or Hype?

The application of AI in the medical field holds great promise for improving patient health, but will doctors and patients feel comfortable using it? Young startups have begun leveraging this technology to prove better health outcomes, but there's still a lot to do.

The Rise of Integrated Data in Medical Device

While the healthcare industry’s tenet--to provide quality patient care and improve outcomes--has remained steadfast, there are some well-documented challenges increasingly impacting today’s medical device industry.

Clinical Monitoring Oversight Toolkit

A biotech company elected to outsource their clinical study monitoring.  As a result, the company needed a toolkit for internal use to evaluate and monitor the quality of the outsourced monitoring effort.
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