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Downstream · Statistics & data

Biostatistics & data management.

Sample size, SAP, statistical programming and clean, analysis-ready data, CDISC where it matters, pragmatic where speed wins. The last mile that turns a completed study into an answer.

People & Research First®
What we do

The work, made concrete.

Not a service brochure, the actual scope, the actual deliverables, and how it plugs into ECS®.

  • Statistical strategy & SAP
    Sample size, primary and secondary analyses, sensitivity and subgroup plans, written for the reader who has to act on it.
  • Data management
    eCRF design, edit checks, medical coding and database lock, on ECS® or on your own system.
  • Statistical programming
    SAS and R, SDTM / ADaM datasets, TLFs, define.xml, reproducible and traceable.
  • Data science
    Where the question needs more than a t-test: modelling, external control arms, synthetic data (see AI Applied). Acceptance of external and synthetic comparators rests on emerging regulatory precedent, so we agree the approach with the regulator before it is built into the analysis.
People behind the work

Every deliverable has a name on it.

Every engagement is led by named specialists who own the outcome. You get the same faces from kick-off to close-out.
Biostatistician reviewing statistical analysis outputs
Deliverables

What you receive.

Every engagement lands with named artefacts you can use.

  • Statistical analysis plan (SAP) & sample-size justification
  • Clean, locked database with query trail
  • CDISC SDTM & ADaM datasets, TLFs, define.xml
  • CSR- and publication-ready outputs
How it fits ECS®

When EDC, monitoring and stats live in the same ecosystem, database lock stops being an event and becomes the last step of a continuous flow. That's how we shorten last-patient-to-report.

See the ECS® ecosystem →
When you'd engage us

Three moments this service earns its place.

If any of these describe where you are, this is the right entry point.

  1. Moment 01

    You need statistical rigour that will survive regulatory review.

  2. Moment 02

    Your data is spread across systems and needs to be made analysis-ready.

  3. Moment 03

    You're planning an external control arm or a synthetic comparator and need the regulatory case for it built alongside the statistics.

Related services

Often engaged together.

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Talk to the team about this service.

Tell us the study or the question, we'll come back with a scoped answer.

Discuss this serviceSee the full arc