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 validated clinical programming workspace , from project planning to signed-off TFLs.
Clymbr Hub SCE is a validated Statistical Computing Environment with project management and programming workspace for clinical SAS, R, and Python. It combines role-based worklists, versioned code control, secure execution, electronic signatures, and a complete audit trail in one GxP-compliant platform.
- SAS · R · Python , multi-language
- Project management + programming workspace
- Check-in / check-out , versioned programs
- 21 CFR Part 11 , audit-ready
Statistical Computing Environment , in the workflow— / 05
upstream
Study objectives and endpoints set the scope for programming work managed inside the SCE.
SAS · R · Python
Multi-language support
First-class support for the languages clinical programming teams use every day, extensible to Python.
21 CFR Part 11
Audit-ready e-signatures
Electronic signatures, reason for change, and immutable logs align with FDA and EU regulatory expectations.
Elastic
Scalable compute
Isolated per-study workers scale from dry-runs to full study re-runs without waiting on IT.
Capabilities
What Statistical Computing Environment 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.
02
Multiple IDE support
Bring your preferred IDE , web editor, SAS Studio, RStudio, or VS Code , all writing back to the same governed repo.
03
Secure execution environment
Isolated compute sessions; no data leaves the validated environment, and keys and credentials never touch the programmer's machine.
04
Centralized workspace
Every study, every program, and every output in one place , searchable across teams, sponsors, and compounds.
05
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.
07
Role-based access control
PM, Lead, Programmer, Reviewer, and Auditor , permissions match your SOPs, not the other way around.
08
Review & approval workflows
Structured review with electronic signatures, ready for 21 CFR Part 11 and EU Annex 11 scrutiny.
09
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 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
Key functionalities
Everything included in Statistical Computing Environment
Clymbr Hub SCE combines project management, multi-language programming, secure execution, and audit-ready controls in one validated clinical workspace.
12 capabilities shipped today
Capability
Secure cloud-based, scalable statistical computing environment
Select any capability to see what it does.
What is a Statistical Computing Environment with project management and programming workspace?
A Statistical Computing Environment (SCE) with project management and programming workspace is a validated, access-controlled platform where clinical programming teams plan, assign, write, execute, review, and archive statistical code in one governed place. It combines role-based worklists, versioned source control, secure SAS/R/Python compute, electronic signatures, and an immutable audit trail so every program, dataset, and output is traceable from assignment to submission. Clymb Clinical's Clymbr Hub SCE is built specifically for regulated clinical trials, giving project managers, biostatistics leads, statistical programmers, QC reviewers, and auditors a single workspace that aligns with 21 CFR Part 11, EU Annex 11, GxP, and CDISC standards.
Project management
Role-scoped worklists, dependencies, due dates, and live status from protocol to database lock keep SDTM, ADaM, and TFL work on track.
Programming workspace
SAS, R, and Python programs are checked out, edited in multiple IDEs, and checked back in with automatic versioning and diffing.
Validated execution
Isolated per-study compute sessions run inside a GxP-aligned environment with access, execution, and change logs exportable on demand.
Because project management and programming live in the same validated environment, handoffs disappear, rework drops, and every action is captured with user, timestamp, and reason for change , ready for sponsors, auditors, and regulators.
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
What is a Statistical Computing Environment with project management and programming workspace?+
It is a validated, access-controlled platform where clinical programming teams plan, assign, write, execute, review, and archive statistical code in one governed place. It combines role-based worklists, versioned source control, secure SAS/R/Python compute, electronic signatures, and an immutable audit trail so every program and output is traceable from assignment to submission.
How does the SCE manage clinical programming projects?+
Project managers break studies into SDTM, ADaM, and TFL tasks, assign programmers and reviewers, set due dates, and track dependencies. Each user sees a role-scoped worklist, and status rolls up live to database lock so nothing falls through the cracks.
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.
How does version control work in the SCE?+
Programs, datasets, and outputs are versioned together through check-in / check-out. Every version captures the user, timestamp, and reason for change, so any deliverable can be reproduced bit-for-bit and reviewed in context.
Can the SCE scale for large studies?+
Yes. Elastic SAS and R workers scale from a single dry-run to full study re-runs without waiting on IT. Compute is isolated per study, and access/execution logging keeps performance and compliance visible.
Does the SCE integrate with other Clymbr Hub modules?+
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.
Who uses the SCE?+
Project managers, biostatistics leads, statistical programmers, data managers, QC reviewers, quality and compliance teams, and auditors/inspectors all work inside the same governed workspace with permissions matched to their SOPs.
See Statistical Computing Environment inside Clymbr Hub.
Bring your team, your study, and your code. We'll show you Statistical Computing Environment working end-to-end alongside the rest of the platform.