Overview of CCS

CCS is an academically focused, full service cardiovascular research organization specializing in phase 1-4 cardiovascular clinical trials and registries. Our service offering spans early clinical development consulting, study design and protocol development. We manage all operational aspects of clinical trials and provide academic presentations and publishing of study results. Early clinical development planning is led by company thought leaders in cardiovascular research and experienced industry analysts. Our clinical operations staff includes both cardiac clinicians and clinical regulatory experts. Our therapeutic focus, academic underpinnings and clinical site relationships uniquely position CCS to assist our clients in the business of cardiovascular clinical research.

Specific services include assistance with clinical development planning and strategy, clinical trial time-cost models, project management,  site selection and study start-up, site contracting, site monitoring, data management, statistical analysis, pharmacoeconomic analysis, , executive committee management (DSMB/CEC/Steering Committee), 24/7 medical monitoring and clinical help lines, SAE reporting, publication and medical writing. We also offer cardiovascular core laboratory services comprising hemodynamic monitoring, SPECT MPI, RVG, Echocardiography, compliance monitoring.

We work closely with 600 cardiovascular investigative sites in North America and Canada, and we have accumulated a wealth of data on their capabilities and study performance metrics within our proprietary Investigator Database Application.

As with any CRO, the measure of success is its past performance, and the highlights below are a clear indication of CCS' capabilities:

• 80% of CCS business is repeat
• CCS historically provides 3 times more sites/trial than industry standard (Source: CenterWatch, May 1999);
• CCS sites historically have enrolled hundreds of patients and consistently rank as top enrollers
• On completed trials, CCS sites have enrolled an average of 10 patients/site/trial.

CCS attributes its success to the following key factors in its approach to management and conduct of clinical research:

• Realistic expectations derived from investigator database driven, project timing models;
• Flexible response to sponsor requirements;
• Rapid turn around of deliverables;
• Risk managed study start-up and patient accrual tactics;  
• Clinically informed project management of requisite trial functions and activities;
• Site/investigator relationships.