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 […]
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 […]
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. […]
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. Click the button below to learn more about how we have helped companies with their clinical trial needs.
Our goal is to optimize every aspect of the research and development process We will: Improve protocol development, including current trends in clinical trial designs and endpoints Benchmark relevant historical trial enrolment with unmet needs and ongoing trial inclusion criteria Develop a clinical strategy including patient segmentation and biomarkers, streamlining operational costs through more efficient […]
Due Diligence is typically performed by investors but can, and should, be conducted by sponsors to increase their chance of financing success, partnering, mergers, acquisitions (M&As), and product licensing. For companies developing multiple products, Due Diligence can also inform and assist in deciding which products to budget for as part of portfolio management. To learn […]
The BBCR mission is to simplify clinical research, encourage cost-effective trials, and help innovators navigate through the regulatory process. Small & Medium Sized Biotech Companies currently moving from pre-clinical studies toward clinical trials in need of interim Chief Medical Officer in need of regulatory strategy consultancy in need of preparing a pre-IND, orphan petition, IND, […]
SCIO is critical for accelerating approval and significantly reducing the costs of drug and medical device development. One of the major challenges facing this industry is the rising cost of clinical trials. Thus, it is crucial to ensure that trials are significantly more efficient and cost-effective with the involvement of strategy at the time of […]
The BBCR mission is to simplify clinical research, encourage cost-effective trials, and help innovators navigate through the regulatory process. Who We Serve: Small & Medium Sized Biotech Companies currently moving from pre-clinical studies toward clinical trials in need of interim Chief Medical Officer in need of regulartory strategy consultancy in need of preparing a pre-IND meeting […]