Real-world evidence (RWE) is increasingly important in clinical trial design and drug approval. RWE is clinical evidence related to patient health status and treatment safety and efficacy that are generated in clinical practice. The FDA developed a framework to use RWE, which may combine with orphan, fast track, breakthrough therapy designation, and accelerated approval to […]
Tagged: Accelerated Drug Approval
BBCR’s team of experts is highly experienced in the areas of Real World Evidence (RWE) for Control Arm, Post-approval Requirements and Disease Natural History. Reach out today to learn more.
September 8th, 2022 | Accelerated Drug ApprovalCategories
- 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
- Partnering with BBCR Consulting streamlines the clinical trial process by delivering tailored clinical and regulatory roadmaps. Our approach focuses on simplified programs and optimized protocols, designed to align seamlessly with each client’s unique requirements.
- BBCR meets clients’ needs in the fast paced and ever-changing regulatory environment. As specialists in Orphan and Personalized Medicine, BBCR helps clients identify areas of need or economic interest and helps them to find homes for treatments for rare diseases and precision medicine.
- 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.