Partnership to deliver comprehensive data standards expertise and conversion capacity to further the agency's ability to review and evaluate data across studies.
- The US Food and Drug Administration (FDA) recently awarded an Indefinite Delivery Indefinite Quantity (IDIQ) contract for "Legacy Data Conversion Services." The contract was awarded to ScenPro, Inc., a woman-owned, small business based in Richardson, Texas. ScenPro is partnering with Octagon Research Solutions, Inc on the performance of the contract. Ultimately the parties will involve the Clinical Data Interchange Standards Consortium (CDISC) to support this large-scale, complex project of converting legacy study data to an electronic standard format(s). CDISC is a global non-profit standards development organization that has established vendor-neutral, platform-independent standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
- The project addresses legacy data that resides in numerous different formats at FDA that must be converted into standard structures. ScenPro and Octagon will work with the agency to harmonize variable names and terminology while supporting the advancement of current standards and the development of new standardized values for domain data as required.
- ScenPro and Octagon will use their combined knowledge and experience to ensure accurate and efficient conversion of legacy data to facilitate answering important scientific and regulatory questions of interest to promote public health.
◦ScenPro, Inc. brings a team of knowledge analysts and domain experts to the project that will manage the project and provide critical technical expertise in modeling, data conversions and data management.
◦Octagon Research Solutions, Inc., a pioneer and leading provider of breakthrough software and services to the life sciences industry, brings deep domain knowledge in clinical research data integration and standardization, proven data conversion and transformation methodologies and a broad capacity to support this large volume legacy data conversion project.
- The initial Task Order was issued for this project and funded using American Recovery and Reinvestment Act (ARRA) funding. This task order supports the conversion of legacy clinical trial data across the Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) to enable Comparative Effectiveness Research (CER) across vaccines, drugs and medical devices
- The conversion of these legacy data into standardized formats will enable the information to be processed with modern analytical software tools and to be merged with other, more recent, clinical study data. This larger collection will provide researchers with a broader view of how medical conditions affect different individuals and how they respond to various treatments.
The contract Award Number is HHSF2232010000391. The requirement was awarded to a small business and was competitively full and open to all small business firms who wished to compete. The IDIQ contract contains a base ordering period of 5 years.
- Michael Gately, President, ScenPro, Inc., added, "This milestone project highlights the critical nature of data standards in the evaluation of safety and efficacy of new therapies. We are excited about the opportunity to leverage our expertise to help the US FDA broaden their use of data standards throughout the agency."
- David Evans, Chief Information Officer, Octagon Research Solutions, Inc., noted, "This project is illustrative of the industry's trend toward data standardization to promote analysis and evaluation of therapies across therapeutic classes to promote public health. Octagon is pleased to be taking an active role in this critical project."
- FDA Award Notification
About ScenPro, Inc.
ScenPro, Inc., is a leader in providing expert technical and professional services in the areas of medical data modeling, medical data standards, systems analysis, and the development of health care informatics systems. As a woman-owned small business, ScenPro serves a highly diverse customer base which includes the National Institute of Health, the Department of Defense and other Federal Agencies.
About Octagon Research Solutions, Inc.
Octagon is a pioneer and leading provider of world class consulting, a breakthrough outsourcing model and game changing software unify clinical data and submission strategy for the global life sciences industry. Octagon's eCTD and CDISC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in London, UK. For more information please visit www.octagonresearch.com.