Jan Peterson, Senior Regulatory Affairs Manager and Project Director, Emmes Corporation

Leverage Data Managers to Strengthen Risk-Based Monitoring Programs

Data managers play a critical, and perhaps under recognized, role in fully realizing the potential of risk-based monitoring (RBM), Jan Peterson, senior regulatory affairs manager and project director at Emmes Corporation, told attendees of the Association of Clinical Research Professionals (ACRP) 2017 Meeting & Expo in Seattle April 29. RBM remains a murky concept in […]

Dr. Keith Eaton Speaking at ACRP 2017

Cancer Survivor Applauds Clinical Trial ‘Miracles’

“Thank you for your efforts to make miracles happen,” Keith Eaton, a leukemia cancer survivor and physician, told attendees at the Association of Clinical Research Professionals (ACRP) 2017 Meeting & Expo in Seattle this morning. Clinical trial professionals follow a higher calling and should be proud of their industry and their achievements, he affirmed. “Clinical […]

Avoiding the Perils and Pitfalls of Miscommunication in Research

A drug trial sponsor insists that a database of study results be locked for analysis even though the data managers know queries remain unresolved. A poorly printed informed consent form leads to an inspection finding of protocol deviations for every subject enrolled in a study at a particular site. An amendment to a protocol that […]

FDA's David Burrow Speaking at the ACRP 2017 Meeting & Expo in Seattle

FDA: Come to Us with Questions, Don’t Wait for Guidances

Instead of waiting for formal U.S. Food and Drug Administration (FDA) guidances, try reaching out directly to FDA officials with your questions, said several Center for Drug Evaluation and Research (CDER) officials at the ACRP 2017 Meeting & Expo in Seattle today. Guidances are inherently slow and their timing unpredictable. However, clinical trial professionals can […]

David Morin

What to Expect from a Clinical Research Bootcamp

Taking part in any good “bootcamp” experience worth the name—be it to better oneself physically, mentally, or in any other way—should significantly challenge an attendee without crushing his or her spirit for doing whatever the task(s) are that serve as the focus of the bootcamp exercises. Further, it might be best not to be a […]