Service 05 / 06
Data Management & Biostatistics
Clean, traceable, submission-ready data.
Overview
Database design, data capture and statistical analysis under one team, so the analysis plan shapes the CRF rather than reacting to it. Systems are validated to 21 CFR Part 11 and outputs are delivered in CDISC standards ready for submission.
- 21 CFR Part 11 validated EDC
- CDISC SDTM and ADaM datasets
- Statistical analysis plans and clinical study reports
Capabilities
What this covers.
Each capability can be contracted on its own or as part of the full service line.
- 01
CRF & Database Design
Case report form design driven by the protocol endpoints and the statistical analysis plan, with edit checks specified before first-patient-in rather than retrofitted.
- 02
EDC Build & Validation
Electronic data capture configuration, user acceptance testing and validation documentation meeting 21 CFR Part 11 requirements.
- 03
Data Cleaning & Query Management
Ongoing data review, automated and manual query generation, site query resolution tracking, and external data reconciliation against lab and safety sources.
- 04
Medical Coding
MedDRA coding of adverse events and medical history and WHO Drug coding of concomitant medications, with a documented coding convention and periodic review.
- 05
Biostatistics
Sample size and power calculations, randomisation schedule generation, statistical analysis plan authoring, and interim and final analyses.
- 06
Statistical Programming & Reporting
SDTM and ADaM dataset creation, tables, listings and figures, define.xml packages, and clinical study report contributions.
Deliverables
What you receive.
Concrete artefacts on an agreed schedule — so progress is verifiable rather than asserted.
- Data management plan and CRF completion guidelines
- Validated EDC build with documented UAT
- Data validation specification and query logs
- Coded datasets (MedDRA, WHO-DD)
- Statistical analysis plan and randomisation schedule
- CDISC SDTM/ADaM datasets, TLFs and define.xml
- Clinical study report statistical sections
Related services
Often engaged alongside this.
Next step
Scope a data management & biostatistics engagement.
Share your protocol synopsis and target timeline. We come back with scope, assumptions and an indicative budget.