AGILE CLINICAL OPERATIONS
A large pharma company experienced enrollment delays due to the complexity of primary endpoint assessments. CCSF was asked to ID new sites with both access to desired patient populations and expertise to capture complex ventricular remodeling data. Using its proprietary investigator database, CCSF pre-qualified 125 sites in the same amount of time it took the competing CRO to pre-qualify 25 sites, drastically increasing enrollment rates and allowing for timely trial completion.
RESPONSIVE PROJECT MANAGEMENT
CCSF navigated clinical and financial complexities across a full scope of service to rescue a failing phase 1b venture capital-funded stem cell trial. From day 1, CCSF embedded thought leaders in trial management and staffed its project team exclusively with cardiovascular research specialists. Informed by clinical and operational expertise, CCSF’s integrated scientific leadership and specialized project team redirected trial progress, ultimately finishing on-budget and on-time. Anchored by sponsor priorities and a deep knowledge of regulatory requirements, our cardiovascular expertise delivered successfully on larger programmatic goals as well, guiding clinical development into phase II.
INVESTIGATOR SPONSORED TRIALS
A large pharmaceutical company asked CCS to manage all aspects of a 400 patient/60 site, investigator sponsored heart failure trial including writing the protocol, IND submission, site selection, regulatory document management, site monitoring, data management and statistics, SAE reporting, DSMB and Steering Committee management, drug distribution, etc. We selected a set of sites from our investigator database with capabilities and interests matched to the protocol. We developed trial milestones jointly with the sponsor for completion of study startup, first/last patient enrolled, first/last monitoring visit, data lock and statistical analysis. We achieved regulatory approvals for all sites 3 months ahead of the projected timelines and enrolled the last patient 4 months ahead of our projected timeline.
FULLY INTEGRATED CORE LAB
In addition to managing hemodynamic trials, CCSF provides a hemodynamic core lab for central quality review and processing of hemodynamic monitoring. CCSF provided this service in response to the FDA’s request for a central core lab to process hemodynamic tracings for a device trial for acute decompensated heart failure patients, since the sponsor’s composite primary end point included hemodynamic measurements. The core lab has proved to be invaluable in terms of real time monitoring and feedback on the quality of the multiple pulmonary capillary wedge pressures obtained for each patient in the trial.
CCSF was recently approached by a venture capital firm together with its funded start-up company offering a diagnostic device for ACS. The company required assistance in clinical development planning and clinical trial management. Working closely with senior management and investors, CCSF wrote a four-year clinical development plan comprising 7 clinical studies, all timed, sequenced and priced using CCSF’s proprietary Project Time-Cost Model. The Plan was approved by the Board, and we are currently implementing the Plan by operationalizing the first ED study.