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.
Clinical biometrics service
Develop and validate clinical trial datasets, statistical outputs, and supporting documentation with programming delivery shaped around your study and team.
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.
Study lifecycle
01 · Plan and specify
Review CRF annotations, the statistical analysis plan, output expectations, standards, conventions, and dependencies with the wider study team.
02 · Build datasets and outputs
Create SDTM and ADaM packages, tables, listings, figures, patient profiles, and other agreed programming deliverables.
03 · Validate and deliver
Apply the agreed validation approach and prepare define.xml or supporting CDISC documentation when included in scope.
How Gurus fits
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.
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
Clear answers before we define the study-specific scope.
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.
Yes. Gurus can support SDTM and ADaM package development, with the precise datasets, specifications, validation approach, and documentation confirmed for the study.
The engagement can be shaped around your established environment, standards, templates, conventions, and review model. Access, interfaces, and responsibilities are confirmed during scoping.
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
Share the study stage, expected deliverables, standards, environment, review model, and timelines already in place.