Biologic treatments show promise in providing clinical solutions to a variety of diseases including rare cancers and precision medicine. Services include: Indications analysis and prioritization Strategic drug assessment Clinical study design and protocol Biomarker strategy Early Clinical Development FDA meeting and submission Pre-ND integrated development plan CRO and project management Study remediation and rescue […]
Tagged: Clinical Study Design
BBCR has experience in biologics for rare diseases and can assist with the development of a targeted strategy to meet your study needs.
March 24th, 2021 | Clinical Study DesignCategories
- Biomarkers & Surrogate Endpoints
- Company News
- Drug Development
- Due Diligence
- Early Clinical Development
- Industry News
- Medical Affairs and Clinical Research
- Miscellaneous
- Orphan Diseases
- Pre-IND
- Precision Medicine
- Rare Disease
- Real World Evidence
- Regulatory
- Regulatory Affairs
- Strategy and TPP
- Translation Medicine and Epigenetics
- Trial Management
- Trial Rescue
Recent Posts
- BBCR is highly experienced in developing innovative approaches to de-risk your product development during the early clinical development stage, including designing Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies. Learn more at bbcrconsulting.com #PoC #PoM #proofofconcept #proofofmechanism #earlyclinicaldevelopment #strategy
- BBCR partners with small and medium sized drug and device biotechnology firms. Our clients are clinical researchers and innovators looking for an efficient path to approval, and come to us from across the globe. Learn more about our consulting services at bbcrconsulting.com.
- From Preclinical through Phase I and POC studies, BBCR provides early clinical research services to enable informed, timely decision-making for our clients. We offer 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.
- With Biomarkers a routine part of drug development, BBCR assists companies with the identification and adoption of biomarkers, especially valuable in rare disease and precision medicine product development.
- “The beginning is the most important part of the work.” — Plato. BBCR is dedicated to developing and nurturing a product’s unique strengths from conception to market. Our expertise with cell, biologics and gene therapy as they relate to rare disease is the cornerstone of our consultancy practice.