Strategy and TPP

SCIO

Drug Repurposing can lower the need for early stage clinical trials. BBCR’s team of industry experts can help match treatments to rare genetic conditions and unsolved diseases.

December 9th, 2021 | Strategy and TPP

According to recently released data, 12 out of the 28 drugs approved in the first quarter of 2020 by the FDA were repurposed drugs. The drug repurposing approval process is an effective tool that accelerates the development of drugs for new indications or drug reformulation. In addition, the development of drug repurposing compared to a […]

BBCR is pleased to present the following White Paper – Surrogate Endpoints for an Accelerated Orphan Drug Approval

November 29th, 2021 | Strategy and TPP

Rare Diseases are conditions that affect less than 200,000 people in the U.S. However, over 7,000 Rare Diseases affect more than 400,000,000 people worldwide, including ~25 million in the U.S. and ~30 million in Europe (1). In recent years, the number of orphan drugs approved has increased significantly. However, developing and marketing orphan drugs remains […]

Medical device companies need to think about clinical data strategy from conception to market, from preparing due-diligence ready datasets for funders to post-marketing safety surveillance for regulatory authorities. BBCR can help.

November 22nd, 2021 | Strategy and TPP

Medical devices have their own special complications as it relates to clinical trials. We work closely with each client to bring device innovation to market faster and more affordably. Working with the BBCR team will help that streamlines clinical trials and help you get through the process faster and more efficiently. March 2021, the FDA […]

Our industry needs innovative strategies, and reduced-risk clinical trials. BBCR clinical development services and drug development consulting integrates real world evidence (RWE) into clinical development plans and regulatory strategies.

November 18th, 2021 | Strategy and TPP

Focus must go to cost containment and value-based developments that allow sponsors to move more treatments to market faster. BBCR’s team expertise in rare diseases and precision medicine combined with SCIO approach helps streamline trials for swift regulatory approvals. Real-World Data can be collected and approved by regulators for Evidence Generation Regarding Safety and Effectiveness. […]

BBCR works with clients beyond consulting, to create cost-effective clinical trials and strategies that nurture product strengths

November 11th, 2021 | Strategy and TPP

Streamlined Clinical Development Strategies 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. Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. […]

Transformation in drug development is ongoing

November 2nd, 2021 | Strategy and TPP

Over the past forty years, the drug development process has changed significantly. In the last twenty years, the industry has invested in gathering scientific data to inform clinical questions. Since 2000, the clinical research’s primary objective has been to marry feasibility and great science to generate anticipatory and adaptive data. Ultimately, to support go-no/go decisions […]

Understanding how a Strategic Clinical Innovation Organization can help streamline the clinical trial process.

October 13th, 2021 | Strategy and TPP

Document preparation and submissions is critical to the success of bringing your product to market. Rely on the BBCR team to know what to submit and when for the most efficient process.

September 30th, 2021 | Strategy and TPP

Documentation of clinical processes and preparing the essential paperwork for timely submission can open doors to expediting the approval process. Boston Biotech Clinical Research can provide: Strategy and guidance for FDA meeting requests, briefing packages, preparation and attendance Author, review and publish original applications, amendments and supplements Prepare or assist in the preparation of regulatory […]

BBCR embraces innovative strategy consulting for effective clinical development plan and regulatory strategy. Reach out today to learn more about how we can help advance your project.

September 15th, 2021 | Strategy and TPP

Our industry needs innovative strategies, and reduced-risk clinical trials. BBCR clinical development services and drug development consulting integrates real world evidence into clinical development plans and regulatory strategies. Focus must go to cost containment and value-based developments that allow sponsors to move more treatments to market faster. BBCR’s team expertise in rare diseases and precision […]

The most efficient path in the clinical research process is a moving target. Biotech innovation and regulatory requirements require constant monitoring. Through BBCR Voice, we aim to share not only our knowledge and expertise, but also solutions to current challenges in the regulatory and research environments.

August 5th, 2021 | Strategy and TPP

BBCR is dedicated to meeting the challenges of developers and investors seeking a clearer path to market. We invite you to bookmark our blog page and follow us across social media to keep abreast of timely and relevant topics in our industry.

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