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 […]
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, […]
The BBCR mission is to simplify clinical research, encourage cost-effective trials, and help innovators navigate through the regulatory process. Small & Medium Sized Biotech Companies currently moving from pre-clinical studies toward clinical trials in need of interim Chief Medical Officer in need of regulatory strategy consultancy in need of preparing a pre-IND, orphan petition, IND, […]
BBCR Consulting offers clinical, regulatory, translational, and biomarker consulting services that support our clients’ needs. Our process is designed to maximize time and cost efficiencies while mitigating risk. We partner with domestic and international companies. Our mission is to support pharma and biotech companies, and nurture their products’ strengths while improving efficiency and safety.
Every clinical study has its unique challenges that initially may not have been factored for, presenting the need for study remediation and rescue. Experienced management can help sponsors to address prolonged trial timeline and high quality data. Rare Diseases and Precision Medicine Require Unique Approaches In Clinical Trial Design. There could be any number of […]
People tend to believe that a repurposed therapy can never be truly novel or transformative. Nothing could be further from the truth. About a third of orphan approvals by the FDA since the program began have been mostly for repurposed mass-market drugs. BBCR’s team of industry experts can help match treatments to rare genetic conditions […]
BBCR helps orphan drug developers find direction in clinical trials involving biologics, biosimilars, small molecules, medical devices, and repurposing. BBCR consultants have the experience to guide you through the development process with a clinical plan and a regulatory strategy. Our team will empower you with medical insight, effective regulatory expertise, strategy, and streamlined early clinical […]
BBCR is looking forward to attending this important event and expresses gratitude to Agile Falcon Strategic Group LLC for the opportunity to be a part of the upcoming Summit. The 9th Clinical Trials Strategic Summit (CTSS) will be taking place in San Francisco October 27th and 28th, 2022. We hope to see you there!
BBCR helps orphan drug developers find direction in clinical trials involving biologics, biosimilars, small molecules, medical devices, and repurposing. BBCR consultants have the experience to guide you through the development process with a clinical plan and a regulatory strategy. Our team will empower you with medical insight, effective regulatory expertise, strategy, and streamlined early clinical […]
BBCR Consulting offers world-class regulatory, clinical research, and biomarker consulting services that provide high-value, and support our clients’ operational and functional needs. Our process is designed to maximize time efficiencies, risk mitigation, and cost savings. Innovating the process of drug development with clinical and regulatory expertise is the central value of our business. BBCR’s mission […]