Interim Analysis & DSMB/DMC Statistical Support
Interim analysis and DSMB/DMC statistical packages: data cuts, TLF programming, QC and traceability under defined access and review rules.
CRO & Statistical Programming Oversight
We support sponsors needing technical judgement to review external deliveries and resolve discrepancies across statistics, programming and data. Oversight results in decisions, owners and closure evidence.
What is included
- Review vendor specifications, derivations, outputs and QC evidence.
- Track issues, dependencies and consistency across the SAP, datasets and deliverables.
- Run technical discussions with CRO and internal teams to clarify acceptance criteria and prioritise corrections.
What you receive
- Review plan and responsibility matrix.
- Issue log with priority, owner and closure criteria.
- Acceptance or remediation recommendations and sponsor summary.
Frequently asked questions
Is this a one-off review or ongoing support?
Either model can be agreed. Deliverables, review frequency, capacity and sponsor decisions determine the engagement.
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