The BBCR team designs Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies with the drug clinical plan and regulatory strategy in mind. Proof of Mechanism (PoM) Usually in Healthy Volunteers, Phase 1 study Essential for the selection of appropriate dose for PoC, disease model and biomarkers Investigate drug concentration at the target […]
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 […]
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 […]
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 […]
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 […]
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 […]
Expanding a product portfolio through the selection of additional indications can offer strategic growth opportunities. However, the process of selecting indications for portfolio expansion requires careful consideration of various factors. Here are few of them for your consideration: Synergy with Existing Capabilities: Building on established strengths can streamline development and increase the chances of success. […]
Providing Expert Guidance for Orphan Drug Development 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 to craft customized strategies that achieve cost-effective trials by 1) simplifying clinical plans, 2) streamlining trial protocols and 3) creating […]
The BBCR team will empower Sponsors with medical insight, ODA application experience, strategic clinical planning, and streamlined trial design.
An early-phase strategy improves productivity and the path to market approval. SCIO SM Advantages Accelerate Patient Recruitment Reduce Patient Number Reduce Clinical Development Time Reduce Trial Monitoring Time Increase Patient Retention Facilitate Decision Making Increase Data Quality The FDA has been calling for a smarter, more innovative process for market approval, and SCIO SM is […]