CARDIOVASCULAR CLINICAL RESEARCH SINCE 1997
We created Tracescribe Research to close the gap between expert cardiology insight and large-trial execution. Our physician-scientists and biostatisticians stay embedded through the full lifecycle, designing endpoint strategy early and delivering submission-ready outputs through a specialized global CV site network.
Scientific leadership reviews every inquiry and responds within 48 hours.
Cardiologists and clinical development experts who built Tracescribe Research to solve a structural problem in cardiovascular trial execution.
Former Chief of Cardiology at a leading academic center. Principal Investigator on landmark heart failure programs.
"We built Tracescribe Research after watching generalist CRO structures fail cardiovascular science."
Cardiologist and imaging specialist with leadership across pivotal PET and nuclear cardiology initiatives.
"When regulators ask who read your images, the answer should remove uncertainty, not create it."
Brings 25+ years of drug development and global clinical operations leadership, translating deep cardiovascular science into predictable program execution.
Oversees medical monitoring, safety surveillance, adjudication strategy, and cross-program risk review across active Tracescribe studies.
Why cardiovascular programs demand specialized infrastructure
How we structure accountability on every program
No steering committee, DMC, or sponsor meeting proceeds without cardiologist representation who can answer endpoint questions in real time.
Imaging charter and biomarker strategies are finalized before protocol lock, not negotiated during vendor selection.
Single quality system spanning clinical operations, imaging, and biomarker workflows-no handoffs between "CRO" and "core lab" quality teams.
Study directors, medical monitors, and core lab leads remain assigned from protocol through regulatory filing. No mid-study reassignments.
End-to-end capabilities designed for cardiovascular programs
Protocol design, endpoint selection, feasibility modeling, and regulatory pathway planning led by cardiologists with submission experience.
Protocol authoring, statistical design, imaging charter development, adjudication strategy, and site selection tailored to cardiovascular endpoints.
Study management, site monitoring, patient recruitment, vendor oversight, and logistics coordination across global cardiovascular site networks.
EDC design, data validation, query resolution, database lock procedures, and CDISC-compliant datasets optimized for cardiovascular trials.
Statistical analysis planning, randomization, interim analyses, DMC support, and final study reporting with cardiovascular expertise.
Real-time enrollment tracking, site performance metrics, imaging compliance dashboards, and predictive risk modeling across study portfolios.
Medical monitoring, safety reporting, adjudication committee management, and cardiovascular-specific adverse event surveillance.
Scientific rigor in imaging and biomarkers, integrated with clinical operations from protocol to submission
Echo, MRI, CT, Nuclear/PET
BICR (Blinded Independent Central Review)
Laboratory strategy and sample management
Database lock is not a rescue event. It is the outcome of decisions made before enrollment begins.
Biostatistics and data management engage at concept stage.
Standards and structures are locked before first patient in.
Execution starts on pre-validated operational and data rails.
Programmatic checks run from first data, not near lock.
A quality confirmation milestone, not an emergency sprint.
Submission-ready datasets and analyses delivered with traceability.
Site networks qualified for complex cardiovascular endpoints
Our site network is not a database rental. It's a continuously credentialed community of investigators, research coordinators, and imaging technicians trained specifically for cardiovascular trial execution.
Every site undergoes therapeutic-specific qualification, imaging competency validation, and EDC training before patient enrollment. Performance is tracked across programs, and underperforming sites are not re-engaged.
One quality system. No handoffs between clinical and core lab operations.
GCP, ICH, FDA 21 CFR Part 11, GDPR, and HIPAA compliance integrated across all clinical and imaging operations.
ISO 13485-aligned QMS with unified procedures for clinical operations, imaging workflows, and biomarker processing.
Continuous monitoring, deviation tracking, and CAPA management ensure every program is sponsor-audit and regulatory-inspection ready.
Validated systems, audit trails, electronic signatures, and ALCOA+ compliance across EDC, DICOM archives, and analytical platforms.
Scientific leadership reviews every inquiry and responds within 48 hours.