Knowledge of disease and its Natural History is an essential element of any clinical development program. Real-World Data (RWD) is data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources. Under the right conditions, data derived from real world sources can be used to build Rare diseases […]
Tagged: RWD
BBCR can help you better understand the role Real World Evidence (RWE) plays for natural history in rare diseases
July 13th, 2021 | RWDCategories
- Biomarkers & Surrogate Endpoints
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- Due Diligence
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- Orphan Diseases
- Pre-IND
- Precision Medicine
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- Translation Medicine and Epigenetics
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- 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.
- 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.