Full-Service Cardiovascular Clinical Research Organization
Our Scientific Acumen, Responsiveness, And Operational Rigor Are Your Advantage
CCS size and structure ensure we’re responsive to your needs and able to make rapid decisions. Embedded in trial management from beginning to end, our thought leaders handle challenges quickly and efficiently as they arise. CCS combines the best qualities from academia and commercial contract research, safeguarding quality and minimizing delays — giving you peace of mind you won’t find anywhere else.
Every year, promising cardiac therapies fail — not because the science was wrong, but because the execution was.
Team rotation
The scientists who win your business disappear after kickoff, replaced by junior associates learning your protocol on the fly.
Late data engagement
Biostatisticians join at the database lock rather than the protocol concept—and spend months untangling what should have been designed correctly from the start.
Scope creep
Conservative budgets turn into change orders. Timelines slip. Your PDUFA date moves.
We built CCS to solve these specific problems. Not with slogans, but with operational commitments we publish and measure against. Combining deep medical expertise and exceptional client focus.
Your data strategy starts at Day 1, not Day 400.
1
Day 1
Biostatistics engaged
2
CRF Design
CDISC locked
3
First Patient In
Enrollment begins
4
Continuous
Programmatic cleaning
5
Database Lock
A formality
6
Topline Results
Submission-ready
Database lock isn't the finish line — it's the verdict on everything you built. CDISC-compliant datasets, estimand-aligned analysis plans, and continuous cleaning from first enrollment mean your DBL is a formality, not a fire drill.
The cardiovascular CRO, built by the cardiologists who lead your trials.
Our founders don't just advise — they're embedded in trial management from protocol to submission. Drs. Konstam and Udelson spent years watching the same tradeoff — academic centers that understood cardiac endpoints but couldn't run a 3,000-patient global trial, and large CROs that could run it but where the cardiologist from the pitch meeting vanished after kickoff. In 1997, they stopped watching and built CCS. Meet the thought leaders delivering expertise at every stage of clinical development.
Marvin A. Konstam, M.D.
Founder & Chief Scientific Officer
Former Chief of Cardiology, Tufts Medical Center. Principal Investigator on SOLVD. Co-founded the Heart Failure Society of America. Authored the first comprehensive heart failure practice guideline.
" We built CCS because we were tired of watching generalist CROs fail cardiovascular programs. "
Personally oversees scientific strategy on every CCS pivotal program from protocol concept through regulatory submission.
James E. Udelson, M.D.
Founder & Chief Medical Officer
Chief of Cardiology, Tufts Medical Center. Writes the nuclear cardiology chapter in Braunwald's Heart Disease. Past President of ASNC. Led the pivotal flurpiridaz F-18 PET trials.
" When your FDA reviewer asks who read your PET images, you want that answer to end the conversation. "
Directs the cardiovascular core laboratory and leads blinded independent cardiac imaging reads on every CCS imaging program.
Lorraine Rusch, Ph.D., FCP
Chief Executive Officer
Brings 25+ years of drug development and clinical operations leadership to CCS's commercial execution.
Ayan Patel, M.D.
Medical Director
Oversees medical monitoring, safety surveillance, and endpoint adjudication across all active CCS trials.
Your cardiac imaging is read by the field's leading authority.
Our Core Laboratory performs blinded independent central reads led by the cardiologist who writes Braunwald's nuclear cardiology chapter and led the pivotal flurpiridaz F-18 PET program. When your FDA reviewer asks who read your cardiac PET images, you want that answer to end the conversation.
ECHO
CARDIAC MRI
CARDIAC CT
NUCLEAR/PET
Full-spectrum cardiovascular clinical development
From protocol concept to regulatory submission — one specialized team, one integrated approach.
Clinical Research Services
Regulatory pathway planning, indication assessment, and competitive positioning informed by 27 years of cardiovascular trial experience.
Protocol development with biostatistical input from Day 1. Estimand-aligned endpoints. Adaptive and Bayesian designs where appropriate.
Site identification, selection, initiation, and monitoring across 2,500+ specialized cardiovascular research sites in 16 countries.
CDISC-compliant from first CRF. Continuous programmatic cleaning from first enrollment. ALCOA+ data integrity at every touchpoint.
Embedded from protocol concept through topline results. SAP development, interim analyses, DSMB support, and submission-ready outputs.
Risk-based monitoring analytics, enrollment forecasting, site performance dashboards, and real-time data quality metrics.
Medical monitoring, SAE management, SUSAR reporting, and safety signal detection integrated with our clinical operations.
Core Laboratory Services
Standardized acquisition protocols for echocardiography, cardiac MRI, cardiac CT, and nuclear/PET across all trial sites.
Blinded independent central review (BICR) led by recognized cardiovascular imaging authorities. The gold standard for regulatory endpoints.
Central biomarker assay management, sample logistics, and integrated biomarker strategy aligned with your clinical endpoints.
2,500+ specialized cardiovascular research sites across 16 countries.
Our global site network is specialized, not general-purpose. We monitor for geographic irregularities and maintain standardized conduct across every region.
1,200+
NORTH AMERICA
800+
EUROPE
350+
ASIA-PACIFIC
150+
LATIN AMERICA
1997
Founded By Cardiologist
2,500+
Specialized CV Sites
16
Countries
I-III
Full Phase Range
0
FDA Complete Response Letters
94%
Team Continuity
Geographic irregularity monitoring across all active sites
Standardized conduct protocols regardless of region
Simplified management — one point of contact, not a bureaucracy
Three commitments. Published. Measured.
"Your team stays your team."
The scientists who design your statistical analysis plan deliver your topline results. We publish our team continuity rate because we believe you shouldn't have to take our word for it.
"Your data strategy starts at protocol design."
Our biostatisticians join before the first CRF is built, not after the first patient enrolls. Estimand frameworks, CDISC standards, and adaptive designs are locked before enrollment opens.
"Your budget reflects reality."
We scope conservatively and price honestly. Every change-order trigger is defined before you sign. No surprise invoices at database lock.
Audit-ready. Always.
Our quality management system is built on ICH E6(R2) risk-based principles with CAPA management, ALCOA+ data integrity standards, and continuous inspection readiness. Quality isn't a department at CCS — it's an operating system.
Risk-Based Monitoring
CAPA Management
ALCOA+
ICH E6(R2)
Connect with CCS to get your drug or device to its next milestone faster.
For a partner that is driven by science and dedicated to heart, choose Cardiovascular Clinical Sciences.
Tell us about your cardiovascular program.
Our scientific leadership responds directly — not a sales team, not a coordinator. Describe your program, and we'll assess fit within 48 hours.
