Medical Research Planning
Develop Roadmap: We work with our clients to develop a roadmap of key activities and deliverables to guide their drug, biologic or medical device through the regulatory pathways to approval. We work closely with the clinical operation group as a dedicated team, focused on completing the project according to specifications. We have extensive experience designing overall clinical development plans, outlining the requisite studies and timelines to help our clients achieve their end-goal in a time-efficient and cost-effective manner. Our goal is to assure that the development program not only meets regulatory requirements, but also supports the desired labeling claims for the compound. Our clinical development plans range from top-line views of the required studies to detailed plans that include individual study synopses and full protocol developments.
Design Clinical Development Plan: Evaluate Alternative Approaches: Due to the continuous increase in time and cost of drug development and the considerable amount of resources required by the traditional approach, companies can no longer afford to continue to late phase 3 with drugs which are unlikely to be therapeutically effective. The future challenge must be for the pharmaceutical industry to slash its research and development costs by achieving a significant cut in the attrition rate for drugs entering preclinical and clinical development, to reduce the development time and to increase the probability of success in later clinical trials by streamlining the development processes. Streamline clinical development through strategy and design improvement save months of trial time, reduce costs by as much as 50%, and maximize trial performance by enrolling the right patients only in the right numbers and testing right end points.
To improve the transition to clinical development it is necessary to validate new targets, define success criteria for research, integrate bio-information at every stage in drug discovery, define prerequisites for development, identify the "losers" and select the "winners" early. Instead of moving from discovery thorough development phases in sequential steps, drug development should be streamlined combining preclinical and early clinical development as an exploratory stage (Stage 0-2A) as a confirmatory stage. Early studies in the exploratory stage of drug development should be designed for a decision making in contrast to later clinical trials that require power for proof-of-safety and efficacy.
Integrate CMC, non-clinical and clinical development: BBCR develops strategic clinical development plans which integrate the product characteristics, manufacturing specifications, regulatory requirements and marketing needs with the reality of patient’s life.