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Depending on your project goals, our consultants’ work with you to design cost-effective early clinical studies that holds potential for reducing Phase III failures.
Our team of consultants can assist in the areas of:
- POM & POC
- Translational Research
- Clinical Plan & Study Design
- Phase 1 & Phase 2 Protocol Development
- Medical Monitors
- Study Management
- CRO Management
- Due Diligence
Why the SCIO?
Clinical trials are expensive and often burdensome on patients. The productivity of pharmaceutical research and development is declining due to high failure rates in clinical research. The investments of resources, time, and funding investments grow with successive stages, from pre-clinical to phase 3. Thus, the cost of a failed phase 3 trial is not just the cost associated with the trial itself but the cost of all prior trials as well as the cost of lost time pursuing a potentially viable alternative.
How does the SCIO address the needs of Drug Development?
- The Strategic Clinical Innovation Organization (SCIO) concept was developed by BBCR, who explicitly designed the SCIO process to help pharmaceutical innovators address the complexity and challenges of high technological, therapeutic product development in evolving regulatory paths.
- The SCIO provides confidence to researchers and innovators seeking a more straightforward path to market.
- The FDA has been calling for a more thoughtful, more innovative approach, and the SCIO is the integrative, multidisciplinary approach to deliver it.
- The SCIO allows for time and cost efficiencies and risk mitigation with a Clear strategy to meet goals, Streamlined protocols for Cost-Effective Trials, Flexible Road-Map, and Robust Clinical Data for a clear and fast path to market.
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.