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Partial Government Shutdown Threatens FDA Activities in 2019

While mission-critical activities related to imminent safety concerns will remain largely untouched during the latest partial government shutdown, activities involving the payment of fees are now in a state of suspended animation. The Food and Drug Administration (FDA) will continue to support activities funded by carryover user fee balances, which allows it to continue to […]

Dr. Fred Johnson, CEO & Founder of InitiativeOne, and ACRP 2019 Signature Series Speaker

Don’t Let Naysayers Undermine Meaningful Strategic Change in 2019

New Year’s resolutions are in the air. Maybe it’s time to renew that gym membership? Should you be calling your mother more often? And when are you going to pick up that electric guitar you bought in 2016? However, embracing change is rarely easy—that’s especially true in the clinical trial industry. There are many reasons […]

Rick Morrison, Founder and President, Comprehend Systems

CROs Can Use Mistakes to Build Trust with Sponsors

You are going to make 773,618 decisions over a lifetime, according to a poll conducted by the makers of the Puzzler Mind Gym 3D game. And you’re going to regret 143,262 of them. If you are a sponsor of clinical trials, one of your decisions should be to sit down with your contract research […]

Carla Balch, CEO, TransMed Systems Inc.

Disappointing One Clinical Trial Applicant Can Have a Negative Ripple Effect

Looking for a way to discourage new trial participants? How about sitting a coordinator down with a prospective patient, then running through a 45-minute inclusion/exclusion criteria review where the second-to-last question abruptly takes the patient out of consideration? “It happens all the time and it’s deflating” for clinical trial practitioners and their patients, says Carla […]