Data integrity from protocol concept to FDA approval
We build every cardiac trial around data integrity - biostatisticians embedded at protocol concept, and submission-ready packages that don't get sent back.
The Problem We Solve
Most CROs treat biometrics as a service line.
That's why the stat team meets you after the protocol is locked, endpoints are fuzzy, and sample size is a guess.
We flip that model: biostatisticians at protocol concept, precise power calculations before site contracts, and submission-ready packages that don't get sent back.
A traditional CRO asks what your endpoints are. We tell you what your endpoints should be - then build the operational infrastructure around statistical rigor, not the other way around.
Our Differentiation
Three Commitments
Endpoint Expertise
Biostatisticians embedded at protocol design - not handed a finished protocol. We define endpoints with regulatory precedent, statistical defensibility, and clinical relevance baked in from day one.
Operational Rigor
Data-first means operations, not just analysis. Centralized monitoring, real-time query management, 21 CFR Part 11 validated systems - all before first patient enrolled. 97% on-time database lock isn't a goal, it's our baseline.
Scientific Partnership
94% team continuity across trials. No handoffs to junior staff after contract signature. The biostatistician who designed your sample size calculation is the same one who writes your CSR. That's how we staff.
Core Services
Full-Service Cardiovascular CRO
From protocol design through regulatory submission - integrated biometrics, operations, and clinical management for global cardiovascular trials.
Biostatistics
Statistical design, power calculations, SAP authorship, interim analyses, and submission-ready datasets (CDISC SDTM/ADaM).
Data Management
EDC build, database design, edit checks, medical coding, query management, 21 CFR Part 11 validated systems, and database lock execution.
Regulatory Support
Protocol development, investigator's brochure, clinical study reports (CSRs), integrated summaries (ISS/ISE), eCTD submissions, and FDA meeting preparation.
Clinical Operations
Site selection, patient recruitment strategies, centralized monitoring, on-site monitoring, medical monitoring, and safety reporting.
Cardiac Imaging
Core lab services for echocardiography, cardiac MRI, CT angiography, and nuclear imaging with centralized endpoint adjudication.
Quality Assurance
GCP audits, vendor qualification, TMF management, CAPA systems, inspection readiness, and regulatory compliance oversight.
About Tracescribe
Built by biostatisticians who got tired of being brought in too late.
Tracescribe was founded in 1997 by senior biostatisticians and data scientists who spent decades consulting for traditional CROs - and watching the same pattern repeat: sponsors designed protocols, locked endpoints, estimated sample sizes, then called the stat team to "run the numbers."
By then, endpoints were fuzzy, power calculations were post-hoc justifications, and the data structure was built for operational convenience, not statistical integrity. Regulatory agencies saw through it. Submissions got delayed. Sponsors paid twice.
We built Tracescribe to flip that model: biometrics first, operations second. The result is faster timelines, cleaner data, and regulatory submissions that don't come back with deficiency letters.
Biostatisticians at protocol concept - not after the protocol is already locked.
Packages built for statistical integrity, not operational convenience.
The statistician who designed your sample size writes your CSR - 94% team continuity.
21 CFR Part 11 validated systems and centralized monitoring before first patient in.
Testimonials
What Our Partners Say
Leadership Team
The People Who Run Your Trial
Senior biostatisticians, data scientists, and trialists - on your program from protocol concept through CSR.
Chief Scientific Officer
15+ years in cardiovascular biostatistics and a former FDA reviewer. Sets endpoint definitions and statistical strategy at protocol concept, with regulatory defensibility built in from day one.
VP of Biostatistics
Doctoral training in biostatistics with 20+ cardiovascular NDAs carried to regulatory approval. Owns SAP authorship, power calculations, and adaptive trial design for MACE endpoints.
Head of Data Management
CDISC-certified, having built EDC systems for 50+ global cardiovascular trials. Runs 21 CFR Part 11 validated data pipelines, edit checks, and medical coding straight through database lock.
Director of Clinical Operations
25+ years of GCP auditing with zero major audit findings across 100+ inspections. Leads centralized monitoring, medical monitoring, and inspection readiness for global cardiovascular programs.
Get in Touch
Let's talk about your trial.
We work with biotech and pharma sponsors at protocol-concept stage. If you're planning a cardiovascular trial and want to discuss statistical design, reach out.
Sponsors from protocol-concept stage through regulatory submission.
Founded 1997 · 150+ global cardiovascular trials.