ACR Image Metrix presents computerized system validation for imaging clinical trials at the DIA forum

Brenda K. Young, BA, CCRA, senior director of clinical operations at ACR Image Metrix™, an imaging contract research organization (CRO) located in Philadelphia, Pennsylvania, has presented her experience in computerized system validation to the Drug Information Association (DIA) 3^rd Annual Clinical Forum held in Nice, France, on October 19, 2009.

Young’s presentation topic, “A CRO’s Challenge—Validating Leading Edge Software for Imaging Clinical Studies,” discussed how conducting imaging clinical trials often involves leading edge software. Computerized systems used in clinical investigations, imaging workstations and software are required to be validated before data is collected in support of regulatory submission. During her presentation, she presented two case studies that described approaches to computer system validation.

“Imaging, as a part of a clinical trial, can involve many different modalities for research; technical validation is a key component of high importance for its usage in a trial whose data will be used to support a regulatory submission. Understanding the work process simulated by testing is key to the performance qualification portion of computer software validation. Knowledge of the mathematics and physics underlying the software and workstation is not necessary to execute a good validation; however, it is critical to possess knowledge of the work process with the computerized system,” Young explained.

“Brenda is an example of the high caliber imaging expertise on staff at ACR Image Metrix. She brings over 25 years of clinical research experience to our team and is on the forefront of validation efforts for imaging clinical research in the industry,” stated Michael Morales, general manager for ACR Image Metrix.