Gary Cramer headshot

Ten Years Have Got Behind Me

Celebrating my 10th anniversary on the job for ACRP at right about the same time as the Association hits its 40th anniversary has been filling my recent days with both melancholy and excitement. It makes me think of the words from “Time,” a favorite Pink Floyd song: “And then one day you’ll find/ten years have […]

Jeff Kingsley

PI Corner: The Evolving Role of the PI

Predicting the future is a fool’s errand. Yet that is what I’ve been tasked to do for this column. So let’s look 10 years into the future at the undiscovered country of 2026. Well…first, let’s look at the forces involved in how principal investigators (PIs) conduct (or don’t) clinical trials today. The future doesn’t simply […]

To Imagine the Future of Clinical Research

There are endless possibilities for the future of clinical research, but the assurance of continued innovation requires reflection on our past experiences to map a pathway forward. In 2000, I started working as a study coordinator. We were entrenched in paper documents such as case report forms (CRFs), patient diaries, and questionnaires. Electronic data capture […]

Clinical Researcher Roundtable: Triumphs and Travails from the Front Lines

In a recent wide-ranging discussion, Franeli (Fran) M. Yadao, MSc, BA, CCRA, a team manager at Emergent BioSolutions, Susan M. Rockwell, MEd, executive director for medical device strategy with ICON plc, and Laurie A. Halloran, BSN, MS, president and CEO of Halloran Consulting Group, shared their greatest professional triumphs, what’s surprised them most in the […]

Challenges and Training Needs for Clinical Research Associates—A Survey

Clinical research associates (CRAs) perform a vital role in monitoring clinical trials. Monitoring undertaken without adequate CRA training, including competency assessment and following a monitoring methodology, can spell disaster.1 Frequent changes in regulations across global regions, variances in participation across multinational and multicenter trials, development issues faced by newer sites, and challenges associated with complex […]