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.

BBCR specializes in the strategy and delivery of early-phase clinical development services to enable informed, timely decision making for our clients.

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 site of action
• Investigate drug engagement with target molecular receptor or enzyme (e.g. Receptor binding
• Investigate if drug biological response after target binding match the desired effect
• Identify the PK/PD relationship

Proof of Concept (PoC)

• In Disease of Interest Patients, Phase 2 study
• Inform on indicative effectiveness of desired clinical activity
• Typically are short and involve a small number of patients
• PoC lack of statistical power
• High quality PoC study yield insight into drug interaction with patient’s physiology
• High quality reads-out enable highly educated Go/noGo decisions

Learn More

Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.

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