01 · Assess and map
Understand the data and standards context.
Review available study assets, selected standards, sponsor conventions, annotated CRF needs, mapping specifications, and gaps in the current package.
Clinical biometrics service
CDISC submission services for structured, review-ready study data.
Implement or convert SDTM and ADaM datasets with aligned metadata, validation checks, define.xml, annotated CRFs, and reviewer documentation.
Bring datasets, metadata, and documentation into one coherent package.
Gurus provides CDISC implementation support for ongoing or legacy study data, connecting source-data context, mapping specifications, SDTM and ADaM datasets, validation findings, metadata, and reviewer documentation. The scope is aligned to the study, selected standards, sponsor conventions, existing assets, and submission strategy.
Core capabilities
- Annotated CRFs and mapping specifications
- Legacy and ongoing data conversion to SDTM
- ADaM specifications and dataset development
- SDTM and ADaM define.xml
- Pinnacle 21 compliance checks
- SDRG and ADRG preparation or review
Study lifecycle
A connected path from source data to submission documentation.
02 · Implement and validate
Develop standards-aligned datasets and review findings.
Support ongoing or legacy conversion to SDTM, develop ADaM specifications and datasets, and run agreed Pinnacle 21 compliance checks.
03 · Document and hand off
Keep metadata and reviewer context aligned.
Prepare or review SDTM and ADaM define.xml, annotated CRFs, SDRG, ADRG, and the documentation included in the agreed handoff.
How Gurus fits
CDISC expertise connected to the wider biometrics workflow.
Gurus can own a defined standards workstream or integrate with clinical data management, statistical programming, biostatistics, and an existing sponsor or CRO team. We agree standards versions, conventions, inputs, review responsibilities, validation expectations, documentation, and handoffs before delivery.
Connected where it helps.
Keep CDISC implementation focused on a defined dataset or package, or connect it with data management and statistical programming for continuity across the study lifecycle.
Common questions
CDISC submission FAQs.
Clear answers before we define the study-specific scope.
Does Gurus support both SDTM and ADaM deliverables?
Yes. Gurus can support SDTM conversion, ADaM specifications and dataset development, related define.xml, annotated CRFs, compliance checks, and reviewer documentation. The exact standards versions and deliverables are confirmed during scoping.
Can you work with both ongoing studies and legacy data?
Yes. The service can be scoped for standards implementation during an active study or for conversion of legacy source data and existing study assets. The starting point, gaps, dependencies, and required outputs are assessed first.
Which submission documents can Gurus prepare or review?
Support can include annotated CRFs, mapping specifications, SDTM and ADaM define.xml, the Study Data Reviewer’s Guide, and the Analysis Data Reviewer’s Guide when they are part of the agreed scope.
How are Pinnacle 21 findings handled?
Gurus can run agreed Pinnacle 21 compliance checks and review the resulting findings in the context of the selected standards, study data, metadata, and documentation. Responsibilities for remediation, explanation, and final approval are defined during scoping.
Your study, your operating model
Define the right CDISC submission scope.
Share the study stage, source data, standards versions, existing specifications, validation findings, documentation, and target handoff.