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FDA Offers Tips on What Triggers Inspections

Clinical trial sponsors, clinical investigators, and institutional review boards often struggle to understand what most often triggers a U.S. Food and Drug Administration (FDA) inspection—especially one that is unannounced. The prospect of an unannounced FDA inspection can loom over a clinical trial site. While the vast majority of inspections are prescheduled, FDA is more likely […]

Jennifer Goldbarb

Leverage Budgeting as Opportunity to Boost Competitive Edge

Believe it or not, a sponsor who pushes back on a site’s budget requests might be doing the site’s leaders a favor. “In some cases, it can show that the site has hidden inefficiencies that make it charge [above the going rate] for a trial or specific piece of a trial,” says Jennifer Goldfarb, MSN, […]

Susan Warne, Associate Site and Patient Networks Director, QuintilesIMS

Patient-Centered Informed Consent Boosts Compliance, Retention

While moral issues are paramount, a strong patient-centered informed consent process can also improve retention and patient compliance, says long-time industry expert Susan Warne, associate site and patient networks director at QuintilesIMS. However, a patient-centric program must not focus solely on the individual in the trial. Trial practitioners should engage other family members and friends […]