Technical review of CRO and vendor deliverables
Technical review of clinical programming deliverables: prioritised findings, acceptance criteria and remediation recommendations.
Senior clinical programming oversight
Support for CROs, biometrics consultancies, pharma and biotech teams that need programming review, issue prioritisation and delivery coordination. Engagements can cover a defined set of deliverables or agreed part-time support.
What you receive
- A review plan with agreed deliverables, milestones and responsibilities.
- Prioritised findings with supporting evidence, a resolution owner and closure criteria.
- A decision record and follow-up of issues within the engagement.
- A summary of delivery status, completed checks and outstanding issues.
What is included
- Review of specifications, SDTM/ADaM derivations, tables, listings and figures, and QC evidence. Technical coordination with designated participants and recommendations for remediation or acceptance against agreed criteria.
When it fits
- You need to review specifications and their alignment with datasets and outputs.
- SDTM/ADaM, TLF or QC issues need clarification and closure.
- Technical coordination is needed across programmers, study leads and vendors.
Frequently asked questions
Can this be part-time support?
Yes. Time allocation, priorities and review frequency are agreed before work starts. Ongoing support depends on confirmed capacity for the contracted period.
See a synthetic programming example
A figure, synthetic data and downloadable R code illustrate the type of deliverable. This is a demonstration, not client work.
See a synthetic programming exampleTechnical review of CRO and vendor deliverables
Related services
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.
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.
Tell us which deliverables need review