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Expertise in integration of in vitro and in vivo analysis during early clinical research is a critical development milestone for efficient candidate development.
In addition, the BBCR team guides in identifying the right target, the right biomarker, the right safety, the right patients and the right commercial potential.
BBCR can assist clients across a variety of areas including:
POM & POC
Proof of Mechanism tests drug interactions at the earliest stage and at a molecular level. Proof of Concept determines the efficacy of a drug prior to late stage confirmation.
Translational Research
Translational Research is critically important because it applies newfound intelligence and insights from laboratory discoveries that will benefit the treatment and prevention of disease.
Clinical Plan & Study Design
Poor planning can derail a clinical study. The importance of sound planning is critical during the development phase of any trial.
Phase 1 & 2 Protocol Development
Phase 1 & 2 assesses the safety and tests the efficacy of a drug or device. Developing protocol is the start to every clinical trial.
Medical Monitors
Medical Monitors provide a medically qualified perspective to ensure high quality data of efficacy and safety in clinical trials.
Study Management
Setting protocols and checkpoints and defining roles and responsibilities makes managing your study more accurate and efficient.
CRO Management
Many clinical staff tasked to oversee vendors lack experience managing people.
Due Diligence
Thoughtful and well-conducted due diligence arms research teams against unnecessary risk, expense and time consuming missteps.
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.