Clinical Data-Science Technologies

From trial data to regulatory-ready evidence, faster.

Validated analytics platforms built for pharma and biotech teams. Bring clinical, real-world, and biomarker data together in one compliant environment.

Contact Sales Explore Products →
  • 21 CFR Part 11
  • SOC 2 Type II
  • HIPAA
  • GDPR
40%faster database lock
250+studies supported
30+pharma & biotech sponsors
0critical audit findings
Products

One validated platform. Five ways to speed up development.

Use each module on its own or combine them. Every one is built to run under GxP.

TrialForge

Clinical data ingestion and SDTM/ADaM transformation pipelines, with full lineage and automated Pinnacle 21 checks.

  • CDISC-native mapping
  • EDC connectors (Rave, Veeva, InForm)
  • Traceable lineage

EvidenceIQ

Real-world evidence analytics. Build external control arms and run comparative effectiveness studies on harmonized RWD.

  • OMOP CDM harmonization
  • Propensity & causal methods
  • HTA-ready outputs

SignalScope

Continuous safety surveillance that uses validated ML to spot pharmacovigilance signals early in trial and post-market data.

  • Disproportionality analysis
  • MedDRA-aware NLP
  • Explainable alerts

CohortLens

Feasibility and site-selection modeling. Predict enrollment, optimize protocol criteria, and reduce costly amendments.

  • Enrollment forecasting
  • I/E criteria simulation
  • Diversity planning

SubmitReady

Automated generation of TLFs and submission packages, with eCTD-compliant define.xml and reviewer guides.

  • Reproducible TLFs (R & SAS)
  • define.xml generation
  • Version-locked outputs

Need something custom?

Our data scientists and statistical programmers work as an extension of your team.

Talk to our team →
Why CDST

Built by biostatisticians, engineered for auditors.

We started as statistical programmers inside large pharma, so we know what slows submissions down. CDST combines modern data engineering with the documentation and validation that regulators expect.

Validated out of the box

IQ/OQ/PQ documentation packages and a GAMP 5 aligned SDLC.

Open, not locked-in

Native R, Python, and SAS support. Export everything in open formats.

Deploy your way

Single-tenant cloud on AWS or Azure, or within your own VPC.

Full reproducibility

Every result is tied to its code, data snapshot, and environment version.

Security & Compliance

Enterprise-grade trust, built in from day one.

21 CFR
Part 11

FDA 21 CFR Part 11

Audit trails, e-signatures, and access controls for electronic records.

SOC 2
Type II

SOC 2 Type II

Security, availability, and confidentiality are independently audited every year.

ISO
27001

ISO/IEC 27001

Certified information security management system.

HIPAA

HIPAA

BAAs available. PHI is encrypted at rest and in transit.

GDPR

GDPR

EU data residency, DPAs, and pseudonymization tooling.

Contact Sales

Let's talk about your pipeline.

Tell us about your studies. A solutions specialist will reply within one business day.

  • Tailored platform walkthrough
  • Validation & security documentation
  • Pricing for your portfolio size

Or email sales@cdst.dev