FDA News

FDA gets trained by SEC Associates on Key Risks and Vulnerabilities within Computer Systems Used for Human Clinical Trials

(July 17, 2007)-- SEC Associates, provider of validation and regulatory compliance services for life sciences organizations, recently delivered a 3-day training workshop to the U.S. Food and Drug Administration at the FDA Staff College in Rockville, Maryland. In response to a request by the FDA, SEC worked closely with senior FDA officials over an 8-month period to develop and deliver this essential training to FDA staff on “Electronic Systems used in Clinical Trials”. FDA was particularly interested in knowing where the key risks and vulnerabilities reside within the many types of computer systems used in human clinical trials. John C. McKenney, Senior Vice President and Thomas C. Grundstrom, Vice President, led the workshop, which was held June 4-6, 2007 at the FDA’s CDRH Staff College.

“Given the increased emphasis on patient safety and data integrity in today’s clinical trials, SEC is honored to play a key role in educating FDA regulatory professionals in this crucial field,” said Lori McKenney, SEC President and CEO. “SEC has provided specialized training to the FDA-regulated pharmaceutical and medical device industries for most of our 18 year history, but this marks the first time that regulators have sought our services,” said McKenney. “It is gratifying to know that we are uniquely positioned to equip both industry and regulators with the training and insight they need to ensure that clinical trial systems are trustworthy and reliable.”

Workshop attendees primarily included FDA compliance officers, reviewers, and field investigators from FDA’s Bioresearch Monitoring Program. In addition to describing basic functionality of core systems used in clinical trials, specific attention was given to how these systems are designed, tested, maintained and integrated by the pharmaceutical, biotech and medical device industries to ensure patient safety and data trustworthiness. The workshop was especially timely with FDA’s issuance in May 2007 of the “Guidance for Industry: Computerized Systems Used in Clinical Investigations”.

In addition to its own staff professionals, SEC invited special guest speakers to give industry and vendor perspectives on key topics of interest to FDA. Catherine Celingant, Director of Clinical Data Management at Millennium Pharmaceuticals, Michael Owings, Vice President of Quality and Regulatory Compliance at Phase Forward, and Chris Decker, Pharmaceutical Industry Technologist at SAS, each provided important insights into clinical data management systems, electronic data capture systems and data analysis systems, respectively.

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