James Valentine, Hyman, Phelps, & McNamara, PC

Patient Voices Often a Neglected Clinical Trial Resource

While we’ve “come a long way” when it comes to actually listening to the patients involved in clinical trials, there’s still a lot more to do, says James Valentine, an attorney with Hyman, Phelps & McNamara, PC. It wasn’t until the late 1980s, as activists protested a perceived lack of U.S. Food and Drug Administration […]

New Report Details 'Unification' Initiatives in Clinical Research

Clinical Operations Professionals Vexed by Industry Fragmentation

Practically everyone’s pursuing the Holy Grail of “unity” in research, according to the Veeva 2018 “Unified Clinical Operations Survey” unveiled today (June 25) at the DIA 2018 conference in Boston. More than 90% of the 331 clinical operations professionals surveyed worldwide said their organizations have a plan in place to get there. The top drivers […]

FDA Commissioner Scott Gottlieb, MD

Gottlieb Helps FDA Reassert Regulatory Influence

It’s now more than 400 days into his tenure as Commissioner of the U.S. Food and Drug Administration (FDA), and Scott Gottlieb has revitalized the agency and put it “back on top,” said Nancy Myers, president and founder of Catalyst Healthcare Consulting. Gottlieb was applauded by all the members of a panel who discussed “Analyzing […]

David Silberman, MPH, Co-Founder, Chairman, Clinical Research Fastrack

TIP Toward Success: Three Quick Steps to Take Your Site from Good to Great

PAID MESSAGE Good research sites get the job done, but great sites are transcendent. What does it take to transform your facility from good to great? Imagine your site exuding competence, collecting impeccable data, winning more trials, and increasing your revenue (along with your salary) from higher enrollment, improved retention, and faster results. What lessons […]