BCRI Trial Management

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