01
Multi-language programming
First-class SAS and R support, extensible to Python. One workspace, one worklist, one audit trail.
CLYMBR HUB · SAS & R VALIDATED ENVIRONMENT
Statistical Computing Environment (SCE)
One clinical programming workflow , from mapping to signed-off TFLs.
Clymbr Hub SCE connects Data Mapper, SAP Builder, TFL Designer, TFL Viewer, and CSR Builder with a full project-management and programming workspace. Check in SAS and R, execute in a validated environment, and capture every approval in one audit trail.
- SAS · R · Python , multi-language
- Check-in / check-out , versioned programs
- 21 CFR Part 11 , audit-ready
- Elastic compute , scalable SCE
Statistical Computing Environment (SCE) , in the workflow01 / 05
inputs
Source data, labs, and external vendor feeds land in the governed environment.
Capabilities
What Statistical Computing Environment (SCE) does
Built around the reality of clinical programming: SOPs, sign-offs, and re-runs included. The SCE is the validated foundation every other Clymbr Hub module runs inside.
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Multiple IDE support
Bring your preferred IDE , web editor, SAS Studio, RStudio, or VS Code , all writing back to the same governed repo.
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Secure execution environment
Isolated compute sessions; no data leaves the validated environment, and keys and credentials never touch the programmer's machine.
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Centralized workspace
Every study, every program, and every output in one place , searchable across teams, sponsors, and compounds.
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Workflow & task management
PM assigns SDTM, ADaM, and TFL work; programmers see what's next; reviewers see what's ready.
06
Version control & audit trail
Programs, datasets, and outputs are versioned together so any deliverable can be reproduced bit-for-bit, with every action captured.
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Role-based access control
PM, Lead, Programmer, Reviewer, and Auditor , permissions match your SOPs, not the other way around.
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Review & approval workflows
Structured review with electronic signatures, ready for 21 CFR Part 11 and EU Annex 11 scrutiny.
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Scalable compute
Elastic SAS and R workers scale from a single dry-run to full study re-runs without waiting on IT.
How it works
Statistical Computing Environment (SCE) in the workflow
Assign, program, execute, approve , a single path for SDTM, ADaM, and TFL work, with the paperwork already done.
PM plans the study
Break the study into SDTM, ADaM and TFL work. Assign programmers and reviewers, set due dates, and track dependencies.
Programmer picks up work
Every programmer sees a personal worklist scoped to their role. Tasks link straight into Data Mapper, TFL Designer, or the code workspace.
Check-out, code, check-in
Check out SAS or R programs, edit in your IDE of choice, and check back in with automatic versioning and diffing.
Execute inside Clymbr Hub
Run SAS and R against controlled compute. Outputs, logs, and datasets are captured and linked to the source program.
Review & approve
Reviewers see diffs, logs, and outputs side-by-side. Sign off is captured in an immutable, audit-ready trail.
clymbrhub.com / studies / H2Q-MC-LZZT / worklist
Demo Study · Safety PopulationMy worklist
All rolesThis sprint
| Task | Role | Assignee | Status |
|---|---|---|---|
DM domain , Demographics DM-014 | SDTM | A. Patel | In progress |
ADSL , subject-level analysis AD-006 | ADaM | R. Chen | Review |
AE by SOC & PT TFL-14.3.1.2 | TFL | M. Silva | Ready to run |
Baseline demographics TFL-14.1.2.1 | TFL | J. Okafor | Approved |
Security & compliance
Built for regulated clinical data from day one.
Every action is authenticated, authorized, and logged. Compute is isolated per study. Signatures and reasons for change are captured in an immutable trail, ready for sponsors, auditors, and regulators.
- ✓21 CFR Part 11 & EU Annex 11 aligned electronic signatures
- ✓SSO (SAML / OIDC), MFA, and IP allow-listing
- ✓Study-scoped RBAC with least-privilege defaults
- ✓Access, execution, and change logs exportable on demand
Audit trail , ADSL v14
- 10:42 · R. ChenChecked out adsl.sas from main
- 11:15 · R. ChenExecuted on SCE worker sce-r-04 · 0 errors
- 11:18 · R. ChenChecked in v14 · reason: add TRTDURD
- 11:47 · P. NakamuraApproved for downstream TFLs · e-signature captured
Standards & compliance
Built to the standards your submission expects
- 21 CFR Part 11
- EU Annex 11
- GxP
- CDISC SDTM
- CDISC ADaM
- CDISC ARS/ARD
- SAS
- R
- Python
- SSO (SAML / OIDC)
- MFA
Who uses it
Teams working in the same workspace
- Project managers
- Biostatistics leads
- Statistical programmers
- Data managers
- QC reviewers
- Quality & compliance
- Auditors and inspectors
Common questions
About Statistical Computing Environment (SCE)
What is a Statistical Computing Environment?+
A Statistical Computing Environment (SCE) is a validated, access-controlled workspace where clinical programming teams write, execute, review, and archive statistical code (typically SAS and R) against controlled data. It combines source-code control, secure compute, workflow, and an audit trail into a single system that meets 21 CFR Part 11 and EU Annex 11 requirements.
How is the Clymbr Hub SCE different from a shared file server plus SAS Grid?+
Clymbr Hub SCE is built around the clinical workflow, not just a file store. Programs, datasets, outputs, and reviews are versioned together, tasks are assigned per role (PM, Lead, Programmer, Reviewer, Auditor), and every check-in, execution, review, and approval is captured with user, timestamp, and reason for change.
Which programming languages and IDEs does it support?+
First-class SAS and R support, extensible to Python, with SAS Studio, RStudio, VS Code, and a web editor. Everything writes back to the same governed repository so the audit trail stays complete regardless of which IDE a programmer prefers.
Is Clymbr Hub SCE 21 CFR Part 11 compliant?+
Yes. The SCE ships with electronic signatures aligned to 21 CFR Part 11 and EU Annex 11, SSO (SAML / OIDC), MFA, IP allow-listing, study-scoped RBAC with least-privilege defaults, and access, execution, and change logs exportable on demand.
Does the SCE work with existing Clymb tools?+
Yes. Data Mapper, SAP Builder, TFL Designer, TFL Viewer, and CSR Builder stay exactly where you left them , the SCE wraps them in project management, code control, and execution, and work assigned in the SCE opens the right tool in context.
See Statistical Computing Environment (SCE) inside Clymbr Hub.
Bring your team, your study, and your code. We'll show you Statistical Computing Environment (SCE) working end-to-end alongside the rest of the platform.