ACROSS AN UNCERTAIN CLINICAL DEVELOPMENT LANDSCAPE… OUR EXPERTS  HELP NAVIGATE  FROM BENCH  TO BEDSIDE
ACROSS AN UNCERTAIN CLINICAL DEVELOPMENT LANDSCAPE… OUR EXPERTS  HELP NAVIGATE  FROM BENCH  TO BEDSIDE

“SOME CROs ARE JUST TOO LARGE”

-Industry Standard Research, CRO Quality Benchmarking Report (11th Edition)

As some sponsors start to question the focus and attention they receive from mega CROs, often attributing reduced responsiveness to increased bureaucracy…

CCS DIFFERENTIATOR:  ACCESSIBLE LEADERSHIP

CCS DIFFERENTIATOR: ACCESSIBLE LEADERSHIP

STEVEN

CHARTIER, RAC

CEO

STEVEN CHARTIER [CHIEF EXECUTIVE OFFICER]

Steve has served as our Chief Executive Officer since September 2019, bringing over 25 years’ experience in the medical device & pharmaceutical industry to his role. He has vast experience designing and executing clinical and regulatory strategy in the Cardiology field, previously serving as Vice President of Regulatory, Quality, and Business Development of SpectraWAVE, Inc., a cardiology-based device company. Steve has held multiple executive positions over the years, including Vice President of Regulatory, Clinical and Quality at Anika Therapeutics, and Chief Operating Officer at PixarBio. Prior to joining PixarBio, Steve spent eight years at the cardiology-based medical device company Infraredx, Inc., where he served in various management positions in clinical, regulatory, quality, and operations, with his most recent position being Chief Operating Officer. In addition, he has held management positions at Nucryst Pharmaceuticals and Biogen. Steve holds certifications in Regulatory affairs & project management and a BA in Psychology from Saint Anselm College.

MARVIN

KONSTAM, MD

FOUNDER & CSO

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.

JAMES

UDELSON, MD

FOUNDER & CMO

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.

HELEN

ZHU, PhD, CPA

CFO

HELEN ZHU [CHIEF FINANCIAL OFFICER]

Helen has served as our Chief Financial Officer since 2006. She brings over 20 years’ experience in financial management, contract negotiations, HR and administrative management to her current role, previously holding managerial position at Johnson Matthey Pharma Service, Inc, and having tax and auditing experiences at KPMG, and PwC. Helen is a licensed CPA and holds a Silver Medal from the 1998 National CPA Exam. She also holds an MBA from Northeastern University, a Ph.D. in Biochemistry from the Ohio State University, and a BS in Virology from Wuhan University.

AYAN

PATEL, MD

MEDICAL DIRECTOR

AYAN PATEL [MEDICAL DIRECTOR, CORE LAB]

Dr. Patel has been recognized as both a leading clinician (Top Doctor, 2016) and academician, with a specific interest in imaging (echo evaluation of cardiomyopathies and heart failure).

PATRICIA WEDGE

RN, BSN, CCRC

VP, CLINICAL OPERATIONS

PATRICIA WEDGE [VICE PRESIDENT, CLINICAL OPERATIONS]

Patty was hired as CCS’ first employee in 1997 and has served as our Vice President of Clinical Operations ever since. She brings more than 25 years’ experience in both clinical medicine and cardiovascular trials to her current role, starting her career in the Lipid Metabolism Laboratory at the USDA Human Nutrition Research Center at Tufts University in 1985. In 1996 Patty became a research coordinator and worked as a heart failure nurse at New England Medical Center (later Tufts Medical Center) in the Division of Cardiology /Advanced Heart Failure Ambulatory Clinic where she continues as a per-diem staff nurse ½ day per week. Patty has been a member of the Heart Failure Society of America and has certification through the Association of Clinical Research Professionals since 1996.

DOUGLAS

DOWLING

VP, DATA MANAGEMENT

DOUGLAS DOWLING [VICE PRESIDENT, DATA MANAGEMENT]

Doug has served as our Vice President of Data Management and Core Laboratory since 2005. He brings more than 25 years of experience to his current role, previously holding senior positions at firms such as DuPont and Merck Pharmaceuticals working on imaging agent programs. From 1993 to 2000 Doug worked at Tufts Medical Center as a programmer and systems analyst in the Nuclear Medicine, Radiology, and Cardiology departments where he worked with Drs. Konstam and Udelson on research projects including the SPAN-CHF program and multiple imaging core lab studies. He joined CCS in 2004 and has managed the Data Management and Core Laboratory departments on more than 35 studies from phase I-III, drug, device, biologic, and imaging agent trials. Doug holds a B.S. in Biomedical Engineering from Boston University.

DOUGLAS

GREGORY, PhD

VP, BIOSTATISTICS

DOUGLAS GREGORY [VICE PRESIDENT, BIOSTATISTICS]

Doug has been our lead statistician since 2005. He brings more than 30 years’ experience in healthcare management, clinical and health services research to his current role, previously holding senior positions at Tufts Medical Center, Booz, Allen, and Hamilton, and CCS. Prior to these positions Doug spent 3 years developing clinical trial and clinical economic research as the Director of a Health Services Research Center at Henry Ford Hospital. Across greater than 30 publications, he has explored topics ranging from time-cost optimization of complex clinical trials to long term benefits of heart failure disease management. Doug holds a Ph.D. in Managerial Economics and Decision Sciences from the Kellogg School at Northwestern University.
We provide a direct line to our experts, removing unnecessary layers of process from study management to deliver accessible and engaged leadership across all our projects.

IMPACT ON EXECUTION: ACCESSIBLE LEADERSHIP

  • Whereas “bureaucracy overload” may cause mega CROs to lag when rapid decisions are required, CCS streamlines issue escalation by providing direct access to our experts.
  • Access to CCS experts endows sponsors with operational, scientific, and analytic insights amassed over our >180 years of combined cardiovascular research experience.
  • With thought leaders systematically embedded in routine trial management from start to finish, >60 years of cardiovascular clinical expertise informs agile management of emerging challenges throughout execution.