Solution now features Clinical Metadata Repository to meet evolving data standards while providing seamless and more timely workflow for clients from data collection, through analysis to submission
The enhanced offering is designed to help the biopharmaceutical industry reduce time to market and R&D costs for clinical trials, including complex multi-indication trials. PAREXEL is introducing features with its GDO offering including:
- Clinical Metadata Repository: A new offering which provides clients with an extensive standards library to help simplify and automate the data collection and analysis process from protocol development through final study report. The Clinical Metadata Repository provides interoperability between the clinical data collected with different data standards and supports automated mapping into CDISC’s SDTM, and ADaM, effectively reducing mapping workload in data management; and
- Adaptive Trials Offering: A comprehensive set of innovative services and technologies for the design, data management, and logistics necessary for informed planning and execution of adaptive trials. Recognized as a promising approach to create upfront efficiencies and cost savings, clients can utilize adaptive trials to reduce uncertainty when planning, better inform decision making, and reduce risks for subjects and sponsors.
PAREXEL’s GDO services are accessible as part of the Company’s full service clinical trial management and execution or on a functional outsourcing, or Functional Service Provider (FSP), basis. PAREXEL’s FSP approach allows clients to cost-effectively expand their resources to operate in a flexible model and tailored to the unique needs of each trial. The offering is also compatible with all major Electronic Data Capture (EDC) providers.
“As sources of data have increasingly become more diverse, regulatory agencies are requesting greater standardization for submissions. Further, the FDA is encouraging the adoption of alternative trial designs, including adaptive trials, as an increasingly important aspect of the drug development journey,” said Jason Martin, Corporate Vice President, Global Data Operations, PAREXEL. “With PAREXEL’s GDO offering, we are harnessing the power of more than 2,000 global experts to respond to these evolving dynamics with end-to-end, flexible solutions that meet the evolving and diverse needs of our clients, and as a result, accelerate timelines while reducing R&D costs.”
PAREXEL’s enhanced GDO offering with the new Clinical Metadata Repository is the latest addition to PAREXEL’s Connected Journey™ of more than 40 data-driven services and is currently available worldwide. For more information on the enhanced GDO offering please visit: http://www.parexel.com/GDO.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services company, providing a broad range of expertise-based clinical research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology, and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the integrated clinical development and regulatory information management process. Headquartered near Boston, Massachusetts, PAREXEL has approximately 18,900 employees with offices in 85 locations in 52 countries around the world. For more information about PAREXEL International visit www.PAREXEL.com.
PAREXEL and PAREXEL Informatics are trademarks or registered trademarks of PAREXEL International Corporation or its affiliates. All other trademarks are the property of their respective owners.
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Jenny Radloff, PAN Communications
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