PAREXEL has introduced its enhanced Global Data Operations (GDO) solution, with augmented processes and expertise, including data management, statistical programming and biostatistics.
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
- Adaptive Trials Offering: A set of 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.