Boston Biotech Clinical Research Blog
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Through the BBCR blog, we aim to share our knowledge and expertise and also potential solutions to current challenges in the regulatory and research environments. Boston Biotech Clinical Research (BBCR) works with biotech, pharmaceutical, and device companies to develop roadmaps for simplified, streamlined, and cost-effective clinical trials.
Boston Biotech Clinical Research Blog
2w ago
Our selected services include expertise with Biomarkers & Surrogate Endpoints, Regulatory Affairs FDA & EMA, Medical Affairs & Clinical Research, Due Diligence, and Trial Management & Trial Rescue. BBCR’s Strategic Clinical Innovation OrganizationSM (SCIO) method is explicitly designed to help pharmaceutical innovators address their concerns and maneuver around evolving challenges. SCIOSM identifies time and cost ..read more
Boston Biotech Clinical Research Blog
1M ago
We provide expert guidance for Orphan Drug Development by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. 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. Our operational mission is ..read more
Boston Biotech Clinical Research Blog
2M ago
Cell and Gene therapy are the new frontiers in the fight against devastating diseases, including rare diseases and cancers. Clinical trial results have been promising, and the next generation of Cell and Gene therapies holds tremendous promise for many patients and families. We can assist with strategies that move products to market faster, including: A ..read more
Boston Biotech Clinical Research Blog
4M ago
Innovation in clinical research is a long-term need due to several factors, including the high failure rate and skyrocketing costs. Healthcare has been changing rapidly for many years. The COVID-19 pandemic has accelerated by helping drive the shift to value-based healthcare. Instead, the productivity of pharmaceutical development has been declining due to high failure rates ..read more
Boston Biotech Clinical Research Blog
6M ago
Innovation in clinical research is a long-term need due to several factors, including the high failure rate and skyrocketing costs. Several factors contribute to the skyrocketing cost of clinical trials. Integration of advanced technologies into drug development. While these technologies offer valuable insights, they incur additional training, data analysis, and interpretation costs. Complexity of study ..read more
Boston Biotech Clinical Research Blog
6M ago
Our mission is to support domestic and international pharma, biotech, and device companies by nurturing their products’ strengths while improving efficiency and safety. We specialize in strategy and provide early clinical research services to enable informed, timely decision-making for our clients. Learn more about the services we provide within the areas of Early Clinical Research ..read more
Boston Biotech Clinical Research Blog
6M ago
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 ..read more
Boston Biotech Clinical Research Blog
7M ago
While an early clinical strategy offers numerous advantages, it also comes with certain challenges that need to be considered: Limited Information: Limited information available about the investigational product can make it challenging. High Risk of Failure: Developing an early clinical strategy without a comprehensive understanding of potential challenges and risks could lead to significant financial ..read more
Boston Biotech Clinical Research Blog
7M ago
Developing an effective early clinical strategy requires collaboration between various experts. The strategy is a living document that can evolve as new data becomes available and as the project progresses through clinical development. Study Design: The design must be robust enough to answer the intended scientific questions. Safety Assessment: It details how safety will be ..read more
Boston Biotech Clinical Research Blog
7M ago
Early clinical strategy refers to the comprehensive plan and approach that pharmaceutical companies, biotech firms, and researchers develop for the initial phases of clinical development of a new drug. These early phases, typically known as Phase 1 and Phase 2 clinical trials, aim to assess the safety, tolerability, and preliminary efficacy of the investigational product ..read more