Exploration phase includes analysis to identify product development strengths, challenges and gaps. Specifically involves: Technology Appreciation, Interview Sponsor’s members, Review product’s CMC and pre-clinical “in vitro and in vivo” in house data, Review class related published supported data and more.
The analysis products includes the Discovery Report that after Sponsor’s review and vision alignment is finalized in the Project Guideline.
The Regulatory Path Options and Top-line development are evaluated based on review of regulatory guidelines and case of previous experience to relevant technology, therapeutic area, and indication.
The analysis also includes pros and cons of alternatives or parallel avenues to be summarized in a path identification report that after Sponsor’s review and vision alignment is finalized in a Draft Regulatory Strategy.
The strategy formation phase is the proper clinical strategy phase. It includes two steps:
Step One involves the development of an Early Clinical Strategy including the identification of indication/s, patient selection criteria, endpoint, and biomarkers that would facilitate the product’s development for safety, and efficacy.
Step Two includes Sponsor’s review and partnership
BBCR will include an external confirmation by KOLs. Development of questionnaires and other activities focused on an external confirmation of the assumptions including in the clinical strategy and relating to primary therapeutic indication will be performed.
After a careful planning and strategizing client’s clinical research and trials, BBCR expert team will develop a Draft Clinical Strategy (DCS) and a Draft Road-map (DR), both of which will provide our client a clear picture and overview of how their product will have a best opportunity to succeed cost-effectively in the market.
The exit phase is a synthesis phase. Integration of RRD and DCS combined with the senior management comments and feedback to generate the product’s Clinical Regulatory Strategy (CRS). In addition, a comprehensive road-map will be generated to be able to drive the project timeline and milestone.
This phase also means BBCR Consulting will not be involved with our client’s executive decision, but sharing out knowledge and expertise, which will help our clients maximize their opportunity to be successful with their products. At the same time, exit phase doesn’t mean we are leaving our clients on their own; our resources, network, connections, and assistance will always available to our clients.