Target Health is Co-Presenting at BIO on a Panel on Risk-Based Monitoring

 

Dr. Jules T. Mitchel will be presenting at a Panel at the BIO International Convention in Chicago (April 22-25). The panel is entitled Clinical Trials Modernization: The Promises and Challenges of Risk-Based Approaches to Monitoring, and will be held on April 24 at 10:30 am in Building: S401A (Session ID: 1983). Other speakers include James Dixon Senior Vice President, Global Quality & Compliance PPD, Inc. and Ann Meeker-O’Connell Acting Division Director, Good Clinical Practice Compliance CDER, US Food and Drug Administration.

 

Session Description: Monitoring the progress of clinical investigations typically involves frequent visits to each study site. However, general guidelines for Good Clinical Practice (GCP), FDA regulation, and International Conference on Harmonization (ICH) guideline E6 actually provide substantial latitude regarding the extent and nature of clinical trial monitoring. Newer risk-based approaches that leverage centralized data monitoring through electronic data capture systems can lead to significant efficiencies for clinical trial sponsors. A panel representing industry sponsors of clinical research, clinical research organizations, and regulatory authorities will present their current thinking and strategies to streamline study oversight.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com

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