Trial Management
Our experts from leading academic medical centers have over 20 years of experience in the design and execution of Phae 1 - 4 international multicenter trials. Our team has experience with NIH, industry and investigator initiated trials. Our experts will work in a collaborative fashion with your team to formulate a development pathway / strategy from pre-clinical testing to Phase 4 studies.
Our Philosophy
We view ourselves as collaborators who provide consultative services. We provide advice and options. Ultimately it is your investigational device or agent and the choice is yours as to the path you take.
Pre Clinical and Phase 1 Studies
We will work with you to develop efficient studies to confirm feasability, 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 appropriate study population
Selection of primary and secondary efficacy endpoints and safety endpoints
Power Calculations
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 closed testing procedures
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
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
Development of a trial wiki to support dissemination of trial information
Site contracting
Develop regulatory douments 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