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FDA IRB Warning Letters Dominated by Seven Deficiencies

Warning Letters issued by the U.S. Food and Drug Administration (FDA) after Bioresearch Monitoring (BIMO) inspections identified seven common deficiencies related to institutional review board (IRB) activities, according to a report from the agency. The agency did not rank the deficiencies in any order. Those cited:

  • Inadequate initial and/or continuing review of studies
  • Inadequate […]
Glenda Guest, CCRA, RQAP-GCP, TIACR, vice president of Norwich Clinical Research Associates Ltd.

FDA Guidance Emphasizes IRB Meeting Expectations

A flurry of U.S. Food and Drug Administration (FDA) Warning Letters in 2015 related to institutional review boards (IRBs) and their meeting minutes can be taken as an alert about the agency’s seriousness on the matter. “You should always read Warning Letters to see where the FDA is focusing,” says Glenda Guest, CCRA, RQAP-GCP, TIACR, […]

Amber Meriwether, JD, MA, Senior Manager in Contracts and Outsourcing, Astellas Pharma Global Development, Inc.

Strategic CROs, Sponsors Can Benefit from Fluctuating Regulatory Climate

Savvy sponsors and contract research organizations (CROs) can leverage a staggeringly busy and complex regulatory landscape into a competitive advantage, says Amber Meriwether, JD, MA, Senior Manager in Contracts and Outsourcing at Astellas Pharma Global Development, Inc. Many new or pending regulatory changes will be favorable to the clinical trial industry and patients broadly, Meriwether […]

Hugo Cervantes, Vice President of Vault EDC, Veeva Systems

Survey Spotlights Challenges of Handling EDC Properly

A new survey provides some interesting benchmark data that may help clinical study sites get a sense of how they’re performing. Failure to adequately handle electronic data capture (EDC) at the front end continues to add time to trials downstream, said Hugo Cervantes, vice president for Vault EDC with Veeva Systems. His firm produced […]

Anne-Marie Hess, Senior Strategic Advisor, SCORR Marketing

CROs Overstate Sponsor Satisfaction Levels

Contract research organizations (CROs) might be patting themselves on the back a bit too hard, according to a survey from SCORR Marketing, produced in partnership with Applied Clinical Trials. “We discovered that in some respects, CROs have an inaccurate perception of sponsor satisfaction,” says Anne-Marie Hess, senior strategic advisor at SCORR Marketing. “This is […]