BCRI Trial Management
Our experts from leading academic medical centers have over 34 years of experience in the design and execution of Phase 1 – 4 international multicenter trials. Our team has experience with NIH, industry and investigator initiated trials. Our experts at BCRI will work in a collaborative fashion with your team to formulate a development pathway / strategy from pre-clinical testing to Phase 4 studies. We have experience with executing trials enrolling under 100 patients to over 15,000 patients worldwide. We have a network of over 7,000 cardiovascular investigators worldwide, and a network of 225,000 MDs in the United States within which we can identify sites across all therapeutic modalities. We target site selection based upon objective measures of prior performance.
Pre-Clinical and Phase 1 Studies
We will work with you to develop efficient studies to confirm feasibility, PK/PD, proof of concept, and dose identification.
Phase 2 and 3 Trial Protocol Design
We will work with you in protocol and study design including:
- Synopsis of the protocol
- Background / rationale
- Identification of an appropriately broad or enriched study population
- Selection of primary and secondary efficacy endpoints and safety endpoints
- Power Calculations and sample size estimation
- Inclusion / exclusion criteria
- Randomization, blinding, and stratification schemes
- Selection of the dose of your drug including identification of the optimal dose through dose escalation
- Serious adverse event and unexpected adverse event reporting
- Tracking subject withdrawal and temporary / permanent discontinuation of treatment
- Statistical analysis plan development including hierarchical testing and win ratios
- Provide input regarding regulatory process
Trial Operations
- Creation of case report forms and instructions on how to complete them
- Identification of executive and steering committee members
- Identification of clinical event committee and data safety monitoring board members
- Identification of sites from our database of 7,000 sites in 50 countries
- Planning and conduct of trial start up meetings and training investigators in the conduct of the study protocol and Good Clinical Practice
- Trial hotline support 7/24/365 across 50 countries
- Development of a trial educational portal to support dissemination of trial information
- Site contracting and Data Use Agreements
- Develop regulatory documents including informed consent form
- Track and support IRB approval process at sites
- Development of study aids and screening logs
- Creation and dissemination of numbered memos to sites
- Procedures for study termination / completion