BBCR specializes in taking the complexity inherent to the regulatory phase of the approvals and simplifying it by strategizing our support to each client based on product-specific regulatory requirements and functional needs. Our expertise spans: Regulatory Strategy FDA Meeting & Submission Pre-IND Integrated Development Plan Regulatory Submissions
The BBCR team designs Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies with the drug clinical plan and regulatory strategy in mind. Proof of Mechanism (PoM) Usually in Healthy Volunteers, Phase 1 study Essential for the selection of appropriate dose for PoC, disease model and biomarkers Investigate drug concentration at the target […]
The Trial Management That Addresses Risks Experienced management address risks such as: Delayed enrollment Multiple protocol amendments Poor patient retention Poor data quality Prolonged trial completion timeline Poor safety monitor Let BBCR Consulting assist in your clinical trial strategy. Reach out to us to learn more about how we can help.
How can SCIO SM help? To enhance your position, it becomes crucial to demonstrate that your product/technology is the “safe” option for investment and a stand-out opportunity by including a clinical roadmap and development strategy of your product/technology. This roadmap illuminates clearly for the investment team what the target indications will be and the paths […]
Every clinical study has its unique challenges that initially may not have been factored for. Experienced management can help sponsors to address prolonged trial timeline and data quality. Rare Diseases and Precision Medicine require unique approaches to trial execution and data quality. There could be any number of factors that could necessitate a study being […]
BBCR can assist clients in the following areas: Regulatory Strategy Thinking ahead during the regulatory process, we avoid unnecessary hurdles in the approvals process. We identify gaps, work through the right strategies for an effective product application, and prepare for label claims. FDA Meeting & Submission Critical to the success of bringing your product to […]
Developing innovative or repurposing drugs for orphan diseases can be rewarding, but navigating the challenges is not for the faint of heart. Expert guidance is essential in an area where patients are few; a lack of previous studies may hamper progress as you mount an orphan petition and negotiate a clinical plan with the FDA. […]
As one of the first consultancy teams to streamline clinical trials, BBCR’s boutique consulting team specializes in rare disease and orphan indications dedicated to supporting pharmaceutical innovators, and nurturing each product’s strengths. The BBCR Team provides knowledge in cell, biologics and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment Clinical strategy for […]
Translational medicine is a bridge between pre-clinical and early clinical development (from bench to bedside), creating the foundation for precision medicine in late clinical development. A translational medicine program includes the adoption of biomarkers to mitigate clinical trials risk, identify patient subpopulations, facilitate decision-making, and accelerate drugs’ market approval.
How we can help The BBCR team provides knowledge in cell, biologics and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment We offer clinical strategy for orphan diseases and precision medicine RWE can be used to build orphan diseases evidence to support regulatory decisions BBCR serves small and medium sized Biotech Companies, […]