Technical review of CRO and vendor deliverables
Technical review of clinical programming deliverables: prioritised findings, acceptance criteria and remediation recommendations.
Interim Analysis & DSMB/DMC Statistical Support
We prepare statistical evidence for interim reviews and monitoring committees. Each delivery is linked to a data cut, specifications and agreed access and review arrangements.
What you receive
- Interim review package with versioned TLFs.
- Programs and QC evidence.
- Issue and change log across data cuts.
What is included
- Translate protocol, SAP and committee requirements into datasets and outputs.
- Programme and QC safety, efficacy and temporal summaries as scoped.
- Refresh by data cut, resolve discrepancies and document changes.
Frequently asked questions
Does this include stopping-rule or sequential-design development?
Only if explicitly scoped and reviewed as a methodological component. The programming package follows the study's approved rules.
Related services
Senior clinical programming oversight
Senior review of specifications, SDTM/ADaM, TLFs and QC evidence, with technical coordination and an agreed time allocation.
Discuss your project
Tell us about the objective, study stage and deadline. We review the need and availability; we then define the scope with you and prepare a proposal with deliverables, timing and fees.
Do not email patient, clinical or confidential study data. Access and the working environment are agreed before materials are shared.
Discuss your project