Marti Arvin, Vice President of Audit Strategy, Cynergistek

Silos Can Hinder Effective HIPAA Compliance Programs

It’s never been more important—and challenging—to understand and navigate the myriad privacy regulations changing the clinical trial landscape. The Health Insurance Portability and Accountability Act (HIPAA) is complex enough on its own, says Marti Arvin, vice president for audit strategy with CynergisTek, Inc., “but don’t forget Common Rule provisions around protecting the individual, which includes […]

Navigating Device Study Design Presents Unique Challenges

Unlike drug studies, medical device studies have very different timelines and need to have short-term data for the product to go to market effectively, says Victor Chen, director of clinical affairs for Align Technology, principal with the CK Clinical Group, and a member of the Clinical Researcher Editorial Advisory Board. Marketing wants to see “claims […]

Jill Matzat, BSN, RN, CCRT, CCRA, President, Medical Research Management, Inc.

Are Underqualified Monitors Damaging Your Clinical Trials?

Sponsors too often make the mistake of accepting one or two years of tenure from potential monitors as an adequate credential, without properly examining tangible skillsets, says Jill Matzat, BSN, RN, CCRT, CCRA, president of Medical Research Management, Inc. In those cases, sponsors “really don’t know what they’re getting,” she notes. “You’re actually better off […]

FDA Commissioner Scott Gottlieb, MD

FDA Launches Initiative to Promote Clinical Trial Transparency

In an effort to boost scientific progress, new drug innovation, and clinical trial transparency, the U.S. Food and Drug Administration (FDA) will publish certain information from sponsor-produced clinical study reports (CSRs), beginning with documents volunteered by manufacturers following a drug’s approval, Commissioner Scott Gottlieb, MD, announced earlier this week. The agency will select up to […]

Jim Kremidas, ACRP Executive Director

ACRP Expands Member Benefits to Support Continuing Education in Clinical Research

The Association of Clinical Research Professionals (ACRP) today announces an expanded portfolio of member benefits to support continuing education in the clinical research community. ACRP’s 13,000-plus global members now have free yearly access to nearly 80 continuing education programs designed to support professional development and improve the operational performance of clinical trial sites, sponsors, CROs, […]