Implementation of agency wide application

The Food & Drug Administration (FDA), in response to a Congressional mandate, has embarked on an agency wide initiative to support the implementation of the statutory provisions of FDAAA Title VIII. TTI was engaged in the conceptualization, design and implementation of Clinical Trials Information Processing System (CTIPS), the FDA’s implementation of the FDAAA Title VIII. CTIPS encompasses services to help design and develop a fully functional system that would enable the FDA centers (CDER, CBER and CDRH) to comply with the FDAAA Title VIII Requirements as published in the Food and Drug Administration Amendments Act of 2007 with respect to the area of Clinical Trials. The agency’s mandate provides for the Certification, Notification and Linking FDA health information to the NIH Clinical Trials Database in addition to supporting FDA enforcement initiatives. TTI provides a robust Scanning and Data Extraction solution to support the scanning of incoming paper submissions and extracting relevant information into an Oracle database. TTI’s services were recognized by the agency for its crosscutting support in creating an innovative data integration system that allows linking and analysis of FDA compliance data with ClinicalTrials.gov.