CRO & Statistical Programming Oversight
Senior CRO oversight for clinical programming: SAP, SDTM/ADaM, TLF, QC, traceability, issue resolution and external deliverable coordination.
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 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.
What you receive
- Interim review package with versioned TLFs.
- Programs and QC evidence.
- Issue and change log across data cuts.
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
Fractional Biostatistics & Programming Leadership
Statistical study lead and programming lead support by project or agreed allocation: technical coordination, prioritisation, senior review and mentoring.
Discuss your project
Describe the objective, study stage and deadline. We will confirm fit, deliverables, timing and a quote based on complexity and data quality.
Do not email patient, clinical or confidential study data. Access and the working environment are agreed before materials are shared.
Discuss your project