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Data Management and the Paperless Clinical Trial at Target Health Inc.


When developing a drug, biologic or device, it is all about the data. Data need to be accurate, precise, clean and validated so regulators and the public have confidence with what is reported by pharmaceutical and device companies. At Target Health, we have developed a 21CFR Part 11 compliant electronic data capture (EDC) system that allows for direct data entry of clinical trial data over the web. This patented system allows for the creation of source records, controlled by the clinical site, before the data hit our database. Target Health Inc. data management plans are created by the best team in the industry, which includes edit check and data transfer specifications, as well as data review plans to assure data consistency. Finally, Quality by Design meetings take place with our development team, including the sponsor and all relevant stakeholders, to do real-time data reviews. Consequently, we have the ability to respond rapidly to any data issues whether from specific sites, monitoring oversite, or the EDC system itself. As a result, we can lock databases within several weeks of the last patient, last visit (LPLV) monitored.


For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.


Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor



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