Clinical biometrics service

Clinical SAS programming services from data to submission.

Develop and validate clinical trial datasets, statistical outputs, and supporting documentation with programming delivery shaped around your study and team.

Turn study requirements into clear programming deliverables.

Gurus provides clinical SAS statistical programming across study datasets, analysis outputs, validation, automation, and supporting documentation. The work is scoped around your protocol, analysis plan, standards, programming environment, and established review model.

Core capabilities

  • CRF annotation and statistical analysis plan review
  • SDTM and ADaM package development
  • Tables, listings, figures, and patient profiles
  • Reusable macro development and programming automation
  • PK/PD, safety, and integrated summary support
  • Define.xml and supporting CDISC documentation

Study lifecycle

A connected clinical programming workflow.

01 · Plan and specify

Align inputs before programming begins.

Review CRF annotations, the statistical analysis plan, output expectations, standards, conventions, and dependencies with the wider study team.

02 · Build datasets and outputs

Develop what the study needs for review and analysis.

Create SDTM and ADaM packages, tables, listings, figures, patient profiles, and other agreed programming deliverables.

03 · Validate and deliver

Keep review and documentation connected.

Apply the agreed validation approach and prepare define.xml or supporting CDISC documentation when included in scope.

How Gurus fits

Programming capacity aligned to your standards and team.

Gurus can own defined programming deliverables or integrate with an established sponsor or CRO team. We align the programming environment, conventions, inputs, review responsibilities, milestones, and handoffs before delivery starts.

Connected where it helps.

Keep SAS programming as a focused workstream, or connect it with biostatistical review and dedicated CDISC submission support when the scope requires it.

Common questions

Clinical SAS programming FAQs.

Clear answers before we define the study-specific scope.

Which clinical SAS programming deliverables can Gurus support?

Support can include CRF annotation and statistical analysis plan review, SDTM and ADaM package development, tables, listings, figures, patient profiles, validation, automation, and supporting submission documentation.

Do you support both SDTM and ADaM programming?

Yes. Gurus can support SDTM and ADaM package development, with the precise datasets, specifications, validation approach, and documentation confirmed for the study.

Can Gurus work within our programming environment and standards?

The engagement can be shaped around your established environment, standards, templates, conventions, and review model. Access, interfaces, and responsibilities are confirmed during scoping.

How is SAS programming different from the CDISC Submission service?

SAS programming can cover study datasets, analysis outputs, validation, automation, and selected documentation. The CDISC Submission service focuses specifically on standards implementation, conversion, validation findings, define.xml, and reviewer documentation. The two can be engaged separately or together.

Your study, your operating model

Define the right SAS programming scope.

Share the study stage, expected deliverables, standards, environment, review model, and timelines already in place.

Discuss SAS programming needs