A FULL-SERVICE CARDIOVASCULAR CRO

CCS thought leaders work closely with sponsors, leveraging insights from their regulatory expertise and our time-cost model to develop optimal long-range clinical development strategies. Whether for internal use or for investors, we provide access to seasoned experts and proprietary analytics across the following services:
  • Integrated product development plans
  • Literature reviews
  • Expert interviews
  • Pharmacoeconomic analyses
  • Risk management plans
  • FDA meeting planning & support
  • Integrated product development plans
  • Literature reviews
  • Expert interviews
  • Pharmacoeconomic analyses
  • Risk management plans
  • FDA meeting planning & support
Want to know more about our clinical development consultancies? Start the discussion today, and let our experts show you how we help programs navigate from bench to bedside.

With both industry and FDA experience, our thought leaders draw from multi-faceted perspectives to deliver regulatory insights at any stage of clinical development.

MARVIN A. KONSTAM [CHIEF SCIENTIFIC OFFICER]

Dr. Konstam has served as our Chief Scientific Officer since CCS’ founding in 1997, bringing over 30 years’ experience in clinical research to his role. He is currently Chief Physician Executive of The Cardiovascular Center at Tufts Medical Center and Professor of Medicine at Tufts University School of Medicine. Dr. Konstam combines vast regulatory experience on FDA advisory committees with leadership in both industry and academic clinical research. As Chief Physician Executive of The Cardiovascular Center, Dr. Konstam directs all of Tufts Medical Center’s programs in Cardiovascular diseases. He has served as a member of the Cardiovascular and Renal Advisory Panel of the Food and Drug Administration and has consulted for the Centers for Medicare and Medicaid Services as a member of the Medicare Coverage Advisory Committee and in their programs for improving quality of care in heart failure. Dr. Konstam served as President of the Heart Failure Society of America from 2002-2004, during which time he initiated the HFSA’s Research Fellowship Program and played a lead role in driving the American Board of Internal Medicine’s establishment of Advanced Heart Failure and Transplant Cardiology as a secondary subspecialty of Cardiology. He has also served as President of the Association of Professors of Cardiology. Dr. Konstam’s principal clinical interest is heart failure and his principal areas of investigation are ventricular remodeling in heart failure, novel pharmaceutical and device treatment for heart failure, and strategies for improving quality of Cardiovascular care. He was lead author and committee chair for the Agency for Health Care Policy and Research (presently AHRQ) Clinical Practice Guideline on the care of patients with heart failure, and has served on the Heart Failure Guideline panels of the American Heart Association/American College of Cardiology and of the Heart Failure Society of America.
  • Former member, FDA Cardiovascular & Renal Drugs Advisory Committee
  • Former Senior Adviser, Division of Cardiovascular Diseases, NHLBI
  • Former Chief Medical Officer, Heart Failure Biotechnology Firm

JAMES E. UDELSON [CHIEF MEDICAL OFFICER]

Dr. Udelson has served as our Chief Medical Officer since CCS’ founding in 1997, bringing over 30 years’ experience in clinical research to his role. He is Chief of Cardiology and Director of Nuclear Cardiology at Tufts Medical Center as well as Professor of Medicine and Radiology at Tufts University School of Medicine. Dr. Udelson’s thought leadership has been widely recognized as an editor for Circulation HF, FDA advisory committee member, and past president of the American Society of Nuclear Cardiology. He was an Associate Editor for the American Heart Association’s cardiovascular journal Circulation from 2004 – 2016. In 2008, he was appointed as the initial Editor-in-Chief for the AHA’s then new journal Circulation: Heart Failure. Dr Udelson has served on the AHA/ACC/ASNC Radionuclide Imaging Guidelines writing Task Force, as well as numerous national Guideline and Appropriate Use Criteria writing groups, including as a co-chair of the ACC/ACR Writing Committee for Appropriate Use Criteria to Assess Imaging Modalities to Evaluate Chest Pain in the Emergency Department. He has served as a member of the FDA Medical Imaging Drugs Advisory Panel, is an invited advisor to the FDA’s Division of Medical Imaging and Hematology Products, and has been invited as an ad hoc member of the FDA’s Cardiovascular and Renal Drugs Advisory Panel and the Peripheral and Central Nervous System Advisory Panel. Dr. Udelson’s research interests involve studying the effects of new therapeutic modalities in the setting of heart failure and chronic coronary artery disease, as well as studying the development of imaging modalities to assess those effects. He has directed and/or participated in numerous clinical trials on heart failure and cardiac imaging, focusing on the role of new therapies and how they affect remodeling, physiology, function, and outcomes.
  • Former member, FDA Medical Imaging Drug Advisory Committee
  • Former ad-hoc member, FDA Cardiovascular & Renal Drugs Advisory Panel
  • Former ad-hoc member, FDA Peripheral & Central Nervous System Advisory Panel
From FDA meeting preparation to support with submissions, our experts have the regulatory expertise to guide programs at any stage of the approval process. Start the discussion today, and let our experts demonstrate how we help navigate programs from bench to bedside.

Cross-functional teams comprised of a thought leader, project leader, project manager and biostatistician work closely with sponsors across an iterative design process. These dedicated, interdisciplinary teams build each protocol from the ground up, adapting every design element to sponsor priorities across the following services:
  • Investigational plans
  • Time-cost modeling & optimization
  • Trial simulations for adaptive designs
  • Study design (including adaptive trials)
  • Medical writing
  • Investigator brochures
  • Informed consent development
  • Protocol review & optimization
  • Up-front feasibility assessments
  • Operational plans
  • Investigational plans
  • Time-cost modeling & optimization
  • Trial simulations for adaptive designs
  • Study design (including adaptive trials)
  • Medical writing
  • Investigator brochures
  • Informed consent development
  • Protocol review & optimization
  • Up-front feasibility assessments
  • Operational plans
Curious how our cardiovascular expertise can help optimize your study design? Start the conversation today, and let our experts show you firsthand.