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The Strategic Clinical Innovation Organization (SCIO) concept provides biotech, pharmaceutical and device manufacturing companies with a cost-effective, customized approach to clinical development planning.
This approach, pioneered by BBCR, aims to reduce the risks inherent in early stage clinical development. Such risks are particularly acute for:
- Discovery drugs that offer the potential to suit multiple indications
- Combination products
- New drugs and devices
For each of these, changing regulatory requirements and rules require greater precision in clinical program development, from the outset of the developmental process.
The SCIO concept, pioneered by BBCR, provides:
- An early phase roadmap, to visualize goals, action plans and options
- A strategic clinical plan that offers regulatory concurrence
- Trial customization to suit innovative products, concepts, niche markets and regulatory requirements
- Expert support on selection of indications
- Optimized patient selection
- An integrated approach to strategy, which maximizes the potential value of the product
- Facilitated approach, to support management decision making and ongoing drug/device development
The SCIO concept is a bridge,
- Linking preclinical data with market opportunities
- Matching study endpoints with study objectives
- Connecting product potential with actual treatment benefits
Together, this creates a cohesive Phase I/II development plan, offering thought-through FiM and PoC studies.
BBCR’s innovative approach hinges on Simplifying Clinical Research. Reach out today to learn more…
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.