Clinical data management built around accountable delivery
Extend your team with structured support from protocol interpretation and study build through ongoing cleaning, reconciliation, and database-lock readiness—inside an agreed quality and governance model.
Product screen shown with synthetic sample data · click to enlarge
The data work between protocol and database lock
Every engagement is scoped to the protocol, systems, sponsor procedures, study risk, and required deliverables. Services can complement your current EDC and vendor ecosystem; they do not depend on AIClinTrack EDC.
Planning & governance
Protocol review, data-management planning, responsibility mapping, conventions, and quality checkpoints tailored to the study.
eCRF & database support
Requirements, eCRF design support, database specifications, edit checks, test scripts, UAT coordination, and go-live readiness.
Review & query management
Ongoing review, discrepancy identification, query generation, follow-up, ageing oversight, and documented closure.
Reconciliation
Planned handling of safety, laboratory, imaging, eCOA, and other external data, including transfer checks and issue follow-up.
Medical coding support
Controlled coding workflows using sponsor-approved dictionary versions and conventions, including MedDRA and WHODrug where scoped.
Lock & handoff readiness
Final review coordination, issue closure, lock checklists, archive support, and standards-aligned data/document handoff.
A visible path from requirements to finalization
- 1
Align the scope
Confirm protocol needs, systems, roles, standards, timelines, handoffs, and the sponsor’s quality expectations.
- 2
Design the controls
Create the data-management plan, review strategy, specifications, testing approach, and issue pathways.
- 3
Run continuous review
Track data currency and quality, manage queries, coding and reconciliation, and report actionable study metrics.
- 4
Prepare for lock
Coordinate final review, unresolved-item decisions, approvals, controlled lock, archive, and handoff activities.
Designed for traceability and downstream use
Where included in scope, our teams can apply sponsor conventions and support CDISC-aligned collection and handoff activities, including CDASH, SDTM, ADaM, Define-XML, annotated CRFs, and reviewer documentation. Specific deliverables and validation responsibilities are confirmed before work begins.
- Documented review, query, coding, and reconciliation conventions
- Risk-proportionate quality checks and escalation paths
- Traceable decisions, approvals, and controlled handoffs
- System-agnostic delivery within agreed access and SOP boundaries
Add a complete function or the exact capability you need
Choose an operating model that keeps accountability clear and fits your existing team.
Full-study delivery
A defined data-management team and lifecycle scope from planning through database-lock readiness.
Study-specific work package
Focused support for database build, UAT, data cleaning, reconciliation, coding, or close-out.
Functional service support
Named specialists working within agreed sponsor or CRO systems, SOPs, governance, and oversight.
Questions about clinical data management services
Bring your protocol, systems, and pressure points
We will help define a responsible scope, ownership model, and delivery path for your study.