Service
Clinical Data Management
Fit-for-purpose data capture, cleaning and reconciliation, planned around risk and ready for lock.
Overview
Data quality is decided early: in the design of the CRF, the logic of the edit checks and the clarity of the data management plan. We design for the analysis you intend to run.
We take a risk-based view of data management, concentrating attention on data that matters most to participant safety and the integrity of the primary endpoints.
Standards & frameworks we work within
- ICH E6 (GCP)
- CDISC CDASH
- 21 CFR Part 11 and EU Annex 11 principles for electronic records
- ALCOA+ data integrity principles
These are frameworks we work within or align to. They do not imply certification, accreditation or endorsement.
What we deliver
- Data management plan and CRF completion guidelines
- eCRF design input and data validation specifications
- User acceptance testing support
- Discrepancy management and query handling
- External data reconciliation (e.g. labs, SAE reconciliation)
- Medical coding coordination and database lock activities
Typical deliverables
- Data Management Plan
- Data Validation Specification
- Query and discrepancy listings
- Reconciliation reports
- Database lock checklist and documentation
Engagement models
Project-based
A defined scope, timeline and set of deliverables agreed up front.
Dedicated capacity
Specialists embedded in your workflow on a longer-term, scalable basis.
Advisory & ad hoc
Targeted expert input, reviews or surge support when you need it.
Frequently asked questions
Service descriptions are general and informational. Scope, responsibilities and outputs are defined in a written agreement for each engagement.
Explore other services in the services overview.
Discuss clinical data management
Tell us about your programme. We’ll respond with an honest view of how we can help, and where we can’t.