Driven by Science.
Dedicated to Heart.
The team that wins your trial is the team that runs it. A physician-led cardiovascular CRO across drug and device. The same senior cardiologists on every protocol from concept through database lock.
Six decades of cardiovascular research. Forty-five trials. Nine thousand endpoints. One focus. Drug, device, and combination.
Most specialist CROs run drug or device. Tracescribe runs both, in cardiovascular only.
founder CV research
in the last 20 years
across named CV trials
read in-house
CV trial oversight
Cardiovascular CRO
Cardiovascular trials fail at execution, not science. The people who win your trial should be the ones who run it, all the way through database lock.
After thirty years in this field, we built Tracescribe because no one else was doing it this way.
Every year, promising cardiac therapies fail. Not because the science was wrong, but because the execution was.
The A-team vanishes.
The scientists who win your business disappear after kickoff, replaced by junior associates learning your protocol on the fly.
Statistics arrive too late.
Biostatisticians join at database lock rather than protocol concept, spending months untangling what should have been designed correctly from the start.
Budgets become change orders.
Conservative budgets turn into change orders. Timelines slip. Your PDUFA date moves.
The thought leaders and site relationships of an ARO, with the client focus and scale of a commercial CRO. One team.
A commercial CRO gives you speed, technology, and scale. An academic research organization gives you thought leaders who are the actual principal investigators, plus the site relationships that come with them. Tracescribe gives you both.
- Responsiveness & innovation
- Technology & data integrity
- Client focus & scale
Our mission = your goals.
No rotation. No handoffs.
- Thought leaders = principals
- Site & investigator relationships
- Academic rigor
What changes when cardiovascular work stays in-house. Four principles. No exceptions.
No layers between you and the people doing the work. Fast, and shaped around your program.
Cardiologists on Every Protocol
Senior cardiologists engage from protocol concept through database lock. Not as advisors, as decision-makers.
Biometrics Built In
Data management, medical coding, and SAP and mock-shell development in-house, with statistical programming delivered to support sponsor needs.
Adjudication In-House
Blinded independent CEC adjudication performed by Tracescribe cardiologists. Chain of custody from CRF to database stays inside Tracescribe. No subcontractors.
Core Lab Reads Images
Echo, hemodynamic, MRI, SPECT, and PET read in-house by Tracescribe. Not stored. Not shipped to a vendor. Read by people Tracescribe employs.
From development strategy to database lock, the full scope of a cardiovascular trial. All in-house.
Eight capability areas, delivered by one cardiovascular team. No subcontractors between you and the work.
Clinical Development Strategy
Endpoints and protocol concept set with cardiologists who have served on FDA advisory panels.
Trial Planning & Design
Adaptive and Bayesian designs, dual-region strategy, and mock shells built before first patient in.
Clinical Operations
Monitoring and conduct led by directors, with the same senior team from first visit to last.
Data Management
Database build, medical coding, and external data streams reconciled in-house through lock.
Pharmacovigilance & Safety
Case processing and safety surveillance, coordinated with DSMB oversight and blinded event adjudication.
Trial Analytics
Interim analyses and DSMB data packages, plus milestone reporting sponsors can act on.
Biostatistics
SAP locked before database lock. Programming specs, QC, and timelines stay inside Tracescribe.
Core Laboratory Services
Echo, hemodynamic, MRI, SPECT, and PET, with intra- and inter-reader variability in every read.
Blinded. Adjudicated. Defensible.
Most CROs subcontract cardiovascular endpoint adjudication to external CEC vendors. Tracescribe does not. The firm sponsors trust to deliver the data also stands behind the adjudication of its events.
Single chain of custody. Same team. No handoffs.
Handoffs. Vendor disputes. Chain of custody breaks.
Event triggered
Flagged case routed for adjudication.
Package built
De-identified. Treatment blinded.
Blinded review
Two-reviewer minimum, third for disagreement.
Classified
Coded to endpoint definitions. Audit trail preserved.
Locked
Transmitted to biostats. Reopened only by amendment.
From last patient to topline. 35 days.
Three workstreams. One coordinated team. CRA, data management, and biostatistics run concurrently from LPLV. Programming coordination begins five days before lock.
Parallel, not sequential
CRA, DM, and biostats workstreams run concurrently from LPLV. Programming coordination begins five days before lock.
Senior PM in the room
Directors review every milestone. No junior project manager translating between sponsor, sites, and biostats.
Vendor coordination owned by Tracescribe
Statistical programming vendor managed by Tracescribe biometrics. Specs, QC, and timeline accountability stay inside Tracescribe.
Five modalities. One core lab.
Echo, hemodynamic catheterization, MRI, SPECT, and PET. Operated as a central core lab, in-house, for a decade. Not stored. Not subcontracted. Read by people Tracescribe employs.
In a Phase 2 cell-therapy program, Tracescribe ran echo, MRI, and SPECT on the same 220 patients across 20 sites, capturing function, structure, and perfusion together. Core Lab Operations are led by our Director of Core Laboratory Operations. Cardiac PET reads are underway on an active multi-region CAD program.
Two physicians. Six decades of cardiovascular research, academic medicine, and FDA collaboration.
Founder & Chief Scientific Officer, M.D.
30+ YEARS · HEART FAILURE & CARDIORENAL
- Leadership Senior cardiology leadership at an academic medical center · Heart-failure society leadership
- Academic Professor of Medicine & Radiology at an academic medical center
- Regulatory Multiple FDA advisory panels · Close work with CDER & CDRH
Founder & Chief Medical Officer, M.D.
30+ YEARS · NUCLEAR CARDIOLOGY & IMAGING
- Leadership Chief of Cardiology & Director of Nuclear Cardiology at an academic medical center · Nuclear cardiology society leadership
- Academic Professor of Medicine & Radiology · Associate Editor, a leading cardiology journal
- Regulatory Former member, FDA medical imaging advisory committee · Ad-hoc cardio-renal panels
Phase 2 cardiology. Delivered through COVID.
A first-in-population Phase 2 in a rare cardiomyopathy, run through the pandemic. A tightly defined population. Four external data streams. A protocol run like a pivotal.
Multiple blinded core labs plus central biomarker and PK, all in on time. 100% SDV. A Phase 2 run like a pivotal: dual-region regulatory engagement, 1:1 randomization, SAP locked before database lock.
Trusted across the cardiovascular landscape.
Drug, device, biologic, and diagnostic programs · Phase I through pivotal · Single engagements through multi-year partnerships.
Heart failure is half of everything Tracescribe has done. Every subtype. Every phase.
Among them, one of the largest heart failure trials in Tracescribe history: 4,000+ patients across 250 global sites.
Including a Phase 3 pivotal implant trial: adaptive Bayesian design, NA + EU, run for five years through COVID with no conduct issues.
9,000+ cardiovascular endpoints adjudicated in-house across legacy pivotal trials and current programs. Single chain of custody, blinded, defensible.
From first conversation through database lock. The people in the room.
Founder & Chief Scientific Officer, M.D.
Founder & Chief Medical Officer, M.D.
Chief Executive Officer, Ph.D.
Medical Director, M.D.
Director, Project Delivery
Director, Core Laboratory Operations
You'll find the senior team at the year's major cardiovascular meetings.
From Frankfurt to San Diego, we're at the congresses where cardiovascular research gets presented and debated. If you'll be there, let's meet.
Let's talk about your cardiovascular trial.
From first conversation through database lock. Tell us about your program and we'll get the right people in the room.