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 through clinical trial administration, presentation and publication of trial results, and includes Cardiovascular Core Laboratory services. Our therapeutic focus, academic underpinnings, cardiovascular thought leadership, and clinical site relationships uniquely position CCS to assist our clients in the business of cardiovascular clinical research.

CCS specializes exclusively in the area of cardiovascular disease with a focus on the following sub-specialties:

• Acute Coronary Syndrome
• Arrhythmia
• Coronary Artery Disease/Chronic Angina
• Heart Failure
• Hemostasis/Thrombosis
• Peripheral Vascular Disease

CCS has developed a subspecialization in heart failure trials. Since 2000, CCS has worked on 21 clinical trials in acute decompensated and chronic heart failure, enrolling over 7,000 subjects at over 700 investigative sites in the U.S., Europe and South America. CCS staff have worked on major global clinical trials such as Tolvaptan (i.e., five phase 2 and 3 trials over six years) among others. CCS selected, contracted and managed US and Candian sites, managed the global CEC (responsible for adjudicating over 4,000 events) and global medical monitoring and the DSMB for the pivotal EVEREST trial. Many Heart Failure trials include hemodynamic endpoints, and CCS offers the only hemodynamic core lab of which we are aware. CCS thought leaders are innovators in constructing hemodynamic endpoints, and CCS’s operations staff has experience managing clincial trials in heart failure with invasive hemodynamic endpoints (e.g., the Tolvaptan ECLIPSE trial) and a current trial of an approved compound for heart failure with noninvasive measurement of hemodynamic parameters as the primary endpoint.

CCS has also developed a subspecialization in regenerative therapy trials in post-STEMI and Chronic Heart Failure. CCS has managed all aspects of some trials while providing select services such as cardiovascular core laboratory services for others.

CCS manages all operational aspects of clinical trials including site identification and selection from our Investigator Database of over 900 investigative sites; study startup and regulatory document collection, review and approval; site contracting; site management and monitoring; data management and biostatistics; medical and safety monitoring including SAE processing; executive committee management (CEC, DSMB, Steering Committee); cardiovascular core lab for SPECT MPI, Echocardiography, Cardiac MRI, EKG, and hemodynamic monitoring. Early clinical development planning is led by company thought leaders in cardiovascular research, experienced industry analysts, and operations staff.

CCS is located at 75 Kneeland Street/Suite 702, Boston, MA.

Contact Information

Cardiovascular Clinical Studies, Inc.
Douglas Gregory, PHD, President and CEO
75 Kneeland Street
Suite 702
Boston, MA 02111 USA
Phone: 617-423-7999
Fax: 617-423-7034
E-mail:

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