BBCR’s experience and understanding of how the FDA views orphan applications and structuring a development program to deliver the data and rationale to satisfy the FDA can substantially reduce the review period and increase approval.

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– Boston Biotech Clinical Research (BBCR). Strategic Clinical Innovation Experts. Rare Disease, Clinical Trials, Clinical Research, & Biologics. We work with biotech, pharmaceutical, and device companies to develop clinical/regulatory road-maps consisting with simplified clinical programs, streamlined protocols, and cost-effective clinical trials. Our experienced team provides innovative strategies that meet your goals.

by | Feb 16, 2022 | Drug Development, Medical Affairs and Clinical Research, Rare Disease, Real World Evidence

BBCR’s experience and understanding of how the FDA views orphan applications and structuring a development program to deliver the data and rationale to satisfy the FDA can substantially reduce the review period and increase approval.

A strategic approach creates opportunity for time efficiencies

The Orphan Drug Act is an important piece of legislation that uses financial incentives to encourage the development of drugs that treat rare diseases and precision medicine impacting disease sub-populations.

BBCR’s team of experts can help your company create a roadmap specially customized to ensure successful product development.

Visit BBCR Today to 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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