COMPREHENSIVE DATA MANAGEMENT SERVICES

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of all FDA regulated products such as human and veterinary drugs, biological products, medical devices, food and dietary supplements, cosmetics, and products that emit radiation. The FDA receives materials in multiple forms to include but not limited to paper, electronic submissions via online portals, and physical electronic media (diskettes, microfilm, CD, DVD, removable drives). Record materials include but not limited to letters, memoranda, completed forms, statistical and narrative reports, graphics, photographs, and audio / video recordings. In addition, FDA receives physical artifacts such as labels, bottles, syringes, laboratory samples, feed bags, and boxes. FDA records may be stored in a variety of formats including paper, physical electronic, and microform, and server base e-records repositories. FDA receives these reports by electronic submission, mail, phone, fax, email, and via the internet. The FDA Centers who may participate in this contract include: Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Center for Tobacco Products (CTP) The FDA has many Centers with different responsibilities associated with protecting the public health for the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, tobacco products, food supply, and products that emit radiation. To this goal, the Data Management Program will provide a structure for the Contractor to provide diverse data management services. Over time, FDA intends to replace multiple current legacy processes and data systems that are used for the receipt, processing, validation, and assessment of received reports. These transitions may require the adoption of new software, new internet portals, revised Standard Operating Procedures (SOPs), and additional staff training under this contract. Additionally, FDA intends to adopt emerging data exchange standards which may impact future electronic submission procedures. As FDA transitions to new technologies, it is expected that tasks under this contract will be impacted. These impacts will be assessed as they occur and modifications to task orders under this contract may need to be considered. FDA requires a comprehensive solution to best accomplish Center specific mission objectives to satisfy operational data management requirements. These objectives include the following: - Data entry and record management - Implement and promote operational and cost efficiencies The FDA requires data management support services that include: - Receiving data in a variety of physical and electronic formats - Document data entry services, data analysis, tracking services, and stakeholder/user support. - Sorting and routing this data to the correct work area or correct FDA Center that regulates the product described - Scanning physical documents into electronic formats if neededReviewing electronic submissions and making necessary corrections - Entering and indexing data into FDA computer system - Medical coding of reports using various taxonomies (Eg., MedDRA, VeDDRA) - Performing Quality Assurance and Quality Control on data - Participating in the testing and validation of new software systems used to support new and more efficient data entry systems