Company News

The BBCR mission is to deliver cost-effective clinical plans and regulatory strategies for cell and gene therapy programs. We invite you to learn more at bbcrconsulting.com.

July 10th, 2023 | Company News

BBCR’s boutique consulting team specializes in rare diseases and orphan indications and dedicated to supporting pharmaceutical innovators, and nurturing each product’s strengths. The BBCR team provides consultancy in cell, biologics, and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment Clinical strategy for orphan diseases and precision medicine RWE can be used to […]

With Biomarkers now a routine part of drug development, BBCR works with companies in assisting with the identification and adoption of biomarkers, especially valuable in rare disease and precision medicine product development.

June 28th, 2023 | Company News

The FDA recognizes biomarker development as a high priority area for future research. BBCR can help your company with your product development plan and validation.  

BBCR is highly skilled to meet 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 find homes for treatments for rare diseases and precision medicine.

June 20th, 2023 | Company News

BBCR helps orphan drug developers find direction in clinical trials involving biologics, biosimilars, small molecules, medical devices, and repurposing. BBCR consultants have the experience to guide you through the development process with a clinical plan and a regulatory strategy. Our team will empower you with medical insight, effective regulatory expertise, strategy, and streamlined early clinical […]

In orphan diseases and precision medicine, developing a biomarker plan during translation into early clinical development moves treatment to market faster, and still meets the FDA’s expectations.

June 15th, 2023 | Company News

BBCR is honored to have contributed to the work, Bacterial Consortium Therapy for Prevention of Recurrent C difficile Infection, published April 15, 2023 in the JAMA Medical Journal.

June 7th, 2023 | Company News

The microbiome is the collection of genomes, genes, and gene products of the microbiota living in a given environment, such as a soil patch or the gut of a human being. While bacteria are the most prominent players, we also host single-celled organisms known as archaea, fungi, viruses, and other microbes – including viruses that […]

BBCR is dedicated to supporting pharmaceutical innovators in the specialized rare diseases and orphan drug indications by developing and nurturing the product’s unique strengths. We invite you to learn more about our services at bbcrconsulting.com.

May 25th, 2023 | Company News

Specializing in rare diseases, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps clients reach their goals by customizing a clinical and regulatory roadmap of simplified programs and streamlined protocols. Discover the many ways we help our clients by visiting  bbcrconsulting.com or […]

Trial failures can arise from factors such as failing to maintain suitable protocols, being unable to follow FDA guidance, complex procedures for participating patients, slow recruitment, lack of efficacy, safety issues, and/or insufficient funding to complete a trial. BBCR experts provide an understanding of the reasons a trial failed and offer insights to create and execute successful clinical trial management protocols and CRO management. 

May 16th, 2023 | Company News

Trial Management that addresses risks The experienced trial management address risks such as: Scarce enrollment Multiple protocol amendments Poor patient retention Poor data quality Prolonged trial completion timeline Poor safety monitor

BBCR specializes in strategy and provides early clinical research services to enable informed, timely decision-making for our clients. It is our mission to support domestic and international pharma, biotech, and device companies by nurturing their products’ strengths while improving efficiency and safety.

May 9th, 2023 | Company News

Developing innovative or repurposed drugs for orphan diseases can be rewarding, but navigating the challenges is not for the faint of heart. Our regulatory and clinical research consultants are experts in biologics, cell and gene therapies, and small molecule developments. Identifying areas of need or economic interest can help sponsors find homes for treatments for […]

BBCR has been invited to speak at the upcoming 12th Clinical Trials Strategic Summit 2023 May 10th- 11th 2023 in Boston, MA

May 2nd, 2023 | Company News

Speaking Topic:  Increasing Investor’s Evaluation of SME Biotech in a Slumping Market BBCR will be speaking on the challenges investors face and how to successfully navigate today’s Biotech market.

Welcome to BBCR’s next generation website! We invite you to come explore our new site, redesigned to provide a clear overview of how BBCR can help you with early clinical development, rare disease and orphan drug solutions.

April 18th, 2023 | Company News

We are pleased to share with you our newly enhanced website. Over the past several months, our team has carefully reviewed our processes, capabilities, and offerings in order to provide you with the clearest overview of how we help our clients. BBCR is dedicated to supporting pharmaceutical innovators in the specialized rare diseases and orphan […]

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