Gene Therapy Trials Bring Unexpected Challenges

A spate of late 2018 U.S. Food and Drug Administration guidances on gene therapy has significantly changed the 2019 clinical trial landscape, warns Meagan Vaughn, PhD, RAC, a research scientist with Rho. Savvy practitioners should spend some time getting up to speed on the topic, she advises. At Rho, Vaughn provides project leadership for full-service […]

Harness Targeted Metrics to Keep Projects On Track

Tracking key operational indicators such as site activation, enrollment, and monitoring targets can help identify problems in clinical trial projects while they are still relatively tiny and manageable, says Cynthia Venendaal, MPH, PhD, senior vice president for clinical operations (Americas) with Clinipace. Venendaal learned from experience. “When I was at Clinipace initially, we did not […]

Are You Leaving Billing Money on the Table?

Study sites that fail to conduct adequate billing coverage analysis are “leaving money on the table,” says Kelly Willenberg, owner of Kelly Willenberg LLC. “We see people who don’t do a coverage analysis at all, so they have no justification or backup for anything that they’re billing out to Medicare or any other payers that […]

Trained Workforce Drives Technology Advancement in Clinical Trials

“Digital technologies are one of the most promising tools we have for making healthcare more efficient and more patient-focused,” U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, told attendees of a Bipartisan Policy Center conference in a speech he delivered late last month (January 28). Specifically, Gottlieb cited new streams of real-world […]