Target Health Presenting at BIO

 

Target Health is pleased to announce that Dr. Jules T. Mitchel will be presenting at the 2013 BIO International Convention a panel entitled “Clinical Trials Modernization: The Promises and Challenges of Risk-Based Approaches to Monitoring. “ The panel will take in Chicago on Wednesday, April 24, 2013 between 10:30-11:30.

 

Please let us know if you will be at BIO

 

Session Summary: For many pharmaceutical and biotechnology companies, the predominant mechanism for monitoring the progress of clinical investigations involves frequent visits to each clinical investigator site to evaluate study conduct and review data for each enrolled subject. However, general guidelines for Good Clinical Practice (GCP), FDA regulation, and International Conference on Harmonization (ICH) guideline E6 provide substantial latitude regarding the extent and nature of monitoring. Implementation of a risk-based approach to clinical trial monitoring that leverages centralized data monitoring through electronic data capture systems can lead to significant efficiencies for clinical trial sponsors. This session will evaluate current thinking, including perceived barriers and emerging opportunities, from three stakeholder groups: industry sponsors of clinical research, clinical research organizations, and regulatory authorities.

 

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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