Study start-up & design
Protocol input, CRF design, and biometrics planning aligned from kickoff.
Integrated clinical solutions
From protocol to submission, our biometrics specialists work as one connected team — so your data moves through design, capture, analysis, and reporting without the handoffs that cost time and quality.
One connected biometrics chain.
Statistical analysis planning
SAP authoring, estimand strategy, and sample-size justification.
Clinical data management
EDC build, data review, query management, and database lock across four platforms.
Statistical programming
SDTM, ADaM, and TFLs validated to CDISC and submission standards.
Medical writing
Protocols, CSRs, and submission documents aligned to ICH guidance.
Adaptive & complex designs
Group-sequential, Bayesian, and adaptive trials with interim-analysis support.
Regulatory & submission support
Define-XML, ADRG, and inspection-ready documentation packages.
Integrated governance
One accountable biometrics lead across the whole study lifecycle.
One accountable team across the whole biometrics chain.
One team, not five vendors
Fragmented biometrics — a different vendor for data management, programming, and writing — creates handoffs where timelines slip and quality erodes. We deliver the whole chain under one roof, with one accountable lead.
Built for complex trials
Adaptive designs, multi-region studies, and tight regulatory timelines need biometrics planned together from the start. Our integrated model keeps protocol, SAP, database, and submission datasets aligned end to end.
Submission-ready by design
We work backwards from the submission. CDISC standards, traceability, and inspection-readiness are built into every deliverable, not bolted on before lock.
How we work
Design → build → deliver → submit
- 01
Design
Protocol, endpoints, and analysis strategy defined together.
- 02
Build
Database, edit checks, and programming specs developed in parallel.
- 03
Deliver
Clean data, validated outputs, and reviewed reports through to lock.
- 04
Submit
Submission-ready datasets, documents, and regulatory support.
Frequently asked
Questions sponsors ask
Can you take on the full biometrics scope?
Yes — biostatistics, data management, statistical programming, and medical writing as one integrated engagement, with a single accountable lead.
Can we use only part of the offering?
Yes. The integrated model is the default, but every service is available standalone, and our consulting tracks cover advisory-only engagements.
Which EDC platforms do you support?
We build and run studies across four major EDC platforms, selecting the right one for each study's operational needs.
Do you work to CDISC standards?
Yes — SDTM, ADaM, and Define-XML are standard across our deliverables, with Pinnacle21 validation built into every release.