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The Strategic Product Development (SPD) group's focus is to minimize the time to key milestones and maximize the value of your products under development. The SPD team works closely with your clinical development team to strategically integrate the therapeutic and functional expertise necessary for success in today’s complex commercialization environment.
- Detailed and comprehensive development strategies for individual compounds
- Guidance and strategy on lifecycle management for new and existing therapies
- Clinical development plans and individual protocols
- Medical and scientific support to regulatory submission planning and preparation
- Input on site selection strategies
- Support of relationship building with Key Opinion Leaders
- Enrollment enhancement solutions
- Analgesia and Anti-inflammatory
- Neurology
- Psychiatry
- Oncology
- Infectious Disease
- Pediatrics
- Expertise with Oracle Clinical and EDC solutions
- Standardize study reporting using CDISC SDTM methodology
- Accelerating study activities to optimize the integration between Clinical Operations, Data Management, Biostatistics, and Medical Writing
- Recognized leading expertise in adaptive trial design
- FDA liaison for sponsors in preparing clinical trial design and labeling claims
- Provide input on the optimal statistical approach and the design of trials
- Facilitate interim analysis, and DMC/DSMB charters
- Recognized leading expertise in clinical investigations and strategic regulatory services
- Rapid access to the global medical device market through highly acclaimed services
- World-renowned expertise in EU and non-EU regulatory requirements, national requirements, and CE mark certification
Services
- Clinical Development Program consulting in key therapeutic areas
- Scientific, Clinical, and Statistical consultation for the development of clinical study protocols and investigator brochures
- Strategic statistics consulting with a focus on adaptive trial design
- Global Regulatory and Strategic Development consulting for medical device and product/ device combinations
- Unparalleled data and statistics product and program assessment
- Data monitoring (DMC & DSMB) related services
- Access to and networking with Key Opinion Leaders
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