Draft Guidance Provides Direction on eRecords, eSignatures, eSystems, and More

FDA Draft Guidance Spells Out New Part 11 Expectations

An important new draft guidance from the U.S. Food and Drug Administration (FDA) proposes enhanced direction on how to manage electronic records (erecords) and electronic signatures (esignatures) in clinical investigations, how to validate electronic systems (esystems), and how to implement audit trails for erecords. The full draft guidance released on June 21, “Use of Electronic […]

Nikki Christison, CCRA, TIACT, President, Clinical Resolutions, Inc.

Why are Soft Skills So Hard? Part I

In part one of a three-part series, Nikki Christison, CCRA, TIACR, president of Clinical Resolutions, Inc., looks at the ever-growing importance of “soft skills” in the workplace.  In an industry where we are continually being asked to do more/better/faster, the art of communication is often left by the wayside. Whether we are working in a sponsor […]

Pre-Packaged Lab Kits Make Lives Easier, But at What Cost to Sites and the Environment?

Tackling Waste in Clinical Research

I tried to tally them all, but there were just too many. I stopped counting at 153 pre-packaged laboratory kits that had expired before we ever had a reason to use them in the latest ongoing trial at our study site. Receiving a shipment of such kits from a central lab is a routine occurrence […]

Rik van Mol, Vice President of Research and Development Strategy in Europe, Veeva Systems

Transforming Clinical Trials through Industry Collaboration

Heading into 2017, it was widely held that the biggest trend in life sciences would be increased industry collaboration. With the midpoint of the year upon us, it would seem indeed that collaboration has risen to a top strategic priority for many pharmaceutical and biotech companies whose leaders are working together more closely to overcome […]

Peter Malamis, CEO, CRO Analytics

Tufts Findings Make Strong Case for Performance Analytics

A compelling case for utilizing service quality-based performance analytics to improve clinical trial performance is made in a recent article in Clinical Leader (Why Is Study Start-Up Still So Inefficient) highlighting the findings of the latest study out of the Tufts Center for the Study of Drug Development. There are two primary reasons for the strength of […]