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Client Examples

Myocardial Stem Cell Trial. CCS took over a failing phase 1 study for this venture capital funded, regenerative therapy development company. CCS provided comprehensive services to redirect this trial starting with rewriting the protocol and CRFs to site management, monitoring, data management, biostatistics, executive committee management and overall project management. The trial is back on track, and CCS is working with the company to develop and execute its phase 2 protocol. CCS has worked on 4 myocardial stem cell trials for multiple indications through its core laboratory and clinical operations service offerings.

Comprehensive Investigator Sponsored Study. 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.

Large Phase III Trial. A mid-sized pharmaceutical company asked CCS to manage the North American operation of its global, phase III trial.  The trial involved over 350 sites (over 200 of them in North America), enrolling over 4,000 subjects with acute heart failure. CCS successfully competed with a large, global CRO on the basis of CCS’ accelerated site selection process. CCS selected sites from its Investigator Database with capabilities required for this complex, invasive study. Sites were pre-qualified based on responses to written questionnaire and one-on-one interviews. CCS was also selected to energize patient accrual through its intensive site management program. CCS ultimately managed: site selection, study start-up, regulatory document collection and approval, site contracting and payment, Executive Committees including DSMB and CEC. Experienced CCS heart failure nurses prepared patient dossiers for adjudication by the global CEC of over 5,000 cardiovascular end points. The CCS medical monitor managed the global medical monitoring staff, and CCS nurses staffed a complementary 24/7 global help line. CCS was increasingly called upon to energize and accelerate this important global trial as well as multiple other trials for this sponsor.

Hemodynamic Trials. CCS has extensive experience in conducting hemodynamic trials for patients with advanced heart failure. We have conducted two dose-ranging trials with hemodynamic end points for neurohormonal antagonists, ultimately targeting acute decompensated heart failure patients. In both trials we managed the North American sites for studies that entailed elective admission for hemodynamic monitoring. We learned important lessons regarding site selection, study start-up and IRB approval processes for complex trials such as these. The CCS Medical Director presented and published the data from one of these trials and served as medical monitor. We also provided 24/7 clinical help line staffed by cardiac nurses to respond to site questions regarding enrollment and protocol execution. These, and other, steps enabled both trials to meet their enrollment goals and conclude successfully.

Hemodynamic Core Lab. In addition to managing hemodynamic trials, CCS provides a hemodynamic core lab for central quality review and processing of hemodynamic monitoring. CCS 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.

Remodeling Study. A large pharmaceutical company, experiencing enrollment delays, asked CCS to identify new sites for a protocol designed to look at ventricular remodeling in heart failure subjects.  The methodology used for the remodeling primary end point was highly selective.  CCS was able to select sites from its Investigator Database with the requisite capability. CCS’s site selection, study start-up and site management program dramatically increased enrollment rates allowing the Trial to finish on time.

Registry Study. CCS assisted a mid-size pharmaceutical company in administering a global observational study of over 5,000 CAD patients for 83 sites in the US, Canada, Europe, South America. The objective of the study was to provide data on cardiovascular end points in preparation for the sponsor’s phase III imaging study. CCS provided site selection, regulatory document collection, site management, distribution/tracking of non-drug supplies to sites, medical monitoring, project management and participation in publication preparation.

Regenerative Therapy Study of STEMI. This venture capital funded start-up company turned to CCS for rescue of its failing phase I regenerative therapy trial. CCS assumed all functions immediately, re-wrote the protocol and CRFs, re-trained sites that were bewildered by their prior study experience, monitored sites, implemented a new data management system, and performed statistical analysis services. The study is now back on track and meeting milestones for completion and FDA review.

Clinical Development Plan. CCS 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, CCS wrote a four year Clinical Development Plan comprising 7 clinical studies, all timed, sequenced and costed using CCS’ 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.

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