eCRF / EDC build
Database build, eCRF design and validation, edit-check programming across four major platforms.
Supporting every stage of
clinical development
We keep clinical data connected from capture to analysis, giving the study a clearer, more consistent data flow from start to finish.
End-to-end clinical data management services
eCOA / ePRO
Configuration, validation, and operational support for patient- and clinician-reported outcomes.
Medical coding
Standardised coding of clinical data using recognised medical dictionaries, including MedDRA and WHO Drug, applied consistently to GCDMP standards with full traceability.
Data review
Real-time review of clinical data to identify inconsistencies, resolve issues early and keep datasets accurate, complete and ready for analysis.
CDISC deliverables
CDASH-aligned CRFs and SDTM-ready exports for downstream programming.
Database lock
Defined lock criteria, dry runs, and final lock with full audit trail and archive.
Risk-based data management
Integrated risk assessments and review plans help focus attention where it matters most, supporting a compliant, risk-based clinical data management strategy throughout the study.
Data integration
Central lab, IRT, ePRO/eCOA, and CTMS integrations validated end-to-end.
Inspection readiness
21 CFR Part 11, GCP E6(R2/R3), and audit-trail documentation kept inspection-ready throughout the study.
Audit trail review
Structured review of audit trail data to identify unusual activity, data changes and potential quality issues, supporting inspection readiness and confidence in data integrity.
Data management that protects
trial integrity
From the first CRF through to database lock, our data managers keep study data accurate, reduce ambiguity and prevent avoidable rework, making the study easier to manage as it progresses.
First line of defence
Every analysis, CSR, and submission stands on the data management work beneath it.
Senior on every platform
Experienced data managers across Medidata Rave, Veeva Vault, Viedoc, and Clincase.
Inspection-ready records
800+ studies; sponsor inspections closed with no critical or major findings.
Support around the clock
A 24/7 multilingual site helpdesk keeps data flowing across every timezone.
The data management portfolio
EDC services
We build, deploy and operate studies on Medidata Rave, Veeva Vault, Viedoc and Clincase, with a named senior lead on every platform and a build library that shortens set-up without loosening validation.
- Database build and deployment
- Edit-check programming
- Role-based access and site training
- Central lab, IRT, ePRO and CTMS integration
CRF design
CRFs and eCRFs are mapped to CDASH from the first draft, so the data arrive in a shape downstream programming can use rather than one that has to be retrofitted later.
- CDASH-aligned specification
- Therapeutic-area templates
- Annotated, define.xml-ready CRFs
- eCOA and ePRO form design
Vendor oversight
Subject-matter experts in data management and biostatistics oversee outsourced work on the sponsor’s behalf, to ICH-GCP E6(R2/R3) expectations, with the evidence logged as the study runs rather than assembled before an inspection.
- Oversight management plans
- Deliverable and document QC
- Tailored KPI and KQI dashboards
- Vendor selection and transition support
Data warehousing
Where a programme spans several studies or systems, we build the clinical data warehouse beneath it — SDTM-shaped storage, validated loads from every source, and dashboards the wider team can act on.
- Architecture tuned to clinical reporting
- ETL from multiple EDC platforms
- Cross-study programme dashboards
- Access control and change management
EDC across the clinical data lifecycle
EDC implementation
We implement studies on the four EDC platforms our sponsors run, with a named senior lead and a delivery bench on each.
- Medidata Rave
- Veeva Vault
- Viedoc
- Clincase
EDC is the operational backbone of the trial — where sites enter the data, monitors query it, programmers extract it and inspectors eventually read it. We bring senior data managers to each platform rather than a generalist bench, and a reusable build library that shortens set-up without loosening the validation around it.
- Platform selection support Independent input on which platform fits the protocol, the sites and the wider programme.
- Mid-study takeover Migration of an in-flight build and its data to a new platform or vendor, audit trail intact.
- Multi-protocol libraries Sponsor-side standards and study libraries maintained across a programme, not rebuilt per trial.
EDC build & configuration
From eCRF specification through to a configured, integrated database ready for site go-live.
- eCRF specification
- Edit checks
- User access
- Integrations
The build is where most downstream problems are either created or prevented. We specify against CDASH from the first draft, programme edit checks that catch real issues without burying sites in queries, and validate every integration end to end before the first patient is entered.
- Database build Specification, build and configuration per ICH-GCP and 21 CFR Part 11.
- Edit-check programming Range, consistency and cross-form checks — sponsor-defined or drawn from our templates.
- User access and training Role-based access, site training material and training records maintained throughout.
- System integration Central lab, IRT, ePRO/eCOA and CTMS connections, mapped and validated.
Validation & testing
Every release is qualified before it reaches a site, and the evidence is kept as part of the study record.
- UAT
- 21 CFR Part 11
- EU Annex 11
- CSV evidence
Validation is not a phase we pass through — it is documentation we maintain for the life of the study. Test scripts, UAT records, computerised-system validation reports, e-signature configuration and audit-trail settings are held together so an inspector can follow the system from specification to production without a reconstruction exercise.
- Test scripts and UAT Structured testing with sponsor user-acceptance testing before every go-live.
- Validation evidence CSV reports, audit trails and e-signature records shipped with each release.
- Regulatory alignment 21 CFR Part 11 and EU Annex 11 alignment maintained across the study lifecycle.
Study maintenance & support
Protocols change and sites need answers. Both are handled without interrupting data flow.
- Amendments
- Change control
- 24/7 helpdesk
- Multilingual
Once a study is live, the work shifts to keeping it clean and keeping sites moving. Amendments run through change control with re-validation and controlled re-deployment, while a 24/7 multilingual helpdesk keeps sites supported across every timezone the study runs in.
- Mid-study amendments Change control, validation re-runs and controlled re-deployment to live sites.
- Site helpdesk A 24/7 site-facing helpdesk in multiple languages, staffed by people who know the build.
- Ongoing data review Continuous review and query workflow running alongside the build team.
Database lock & close-out
A lock that holds, with the export and archive that follow it prepared in advance.
- Lock criteria
- Dry runs
- SDTM export
- Archive
Lock criteria are agreed early and tested through dry runs, so the final lock confirms a state the team has already reached rather than triggering a scramble. The SDTM-ready export and the study archive are prepared as part of close-out, with the audit trail preserved intact.
- Defined lock criteria Agreed upfront and tracked, so readiness is visible well before the lock date.
- Dry-run locks Rehearsed locks that surface outstanding queries and reconciliation gaps early.
- Export and archive SDTM-ready export and a complete study archive with the audit trail intact.
One connected data flow, from design to lock
We manage each stage as part of one continuous process, with ongoing oversight and risk-based review built in throughout.
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Design
CRF/eCRF specification, EDC build, validation plan, integration mapping.
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Capture
Site go-live, monitored data capture, real-time query management.
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Review
Continuous data review, risk-based monitoring, central oversight.
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Lock
Database lock, SDTM export, archive — audit-trail intact.
A CDM team that stays close to your data
4 EDC platforms supported
24/7 CDM helpdesk
95% staff retention
800+ studies delivered
36 years of experience
Zero critical inspection findings
A 24/7 helpdesk and a fully validated pipeline
Behind every clean database lock is a CDM operation running quietly across timezones — a 24/7 site helpdesk, real-time query workflows, edit-check programming, and a validation evidence trail that auditors can walk through. We treat the EDC build as the operational backbone of the trial, not a back-office function.
Talk to an expert
A data-management stack built for inspection
We work across the major EDC platforms, with risk-based monitoring, medical data review and CDISC validation built into the process. This helps teams catch issues earlier, reduce downstream rework and keep data dependable across every handover.
EDC platforms
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Senior Rave architects, edit-check programmers, and standards leads. Sponsor-side governance on multi-protocol Rave libraries.
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Vault CDB and EDC builds, study libraries, integrations with Veeva CTMS and eTMF.
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Viedoc Designer-led builds with custom-coded edit checks. Senior expertise on EU and Nordic deployments.
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Long-tenure Clincase team — 20+ years of legacy and current study delivery on the platform.
Data Infrastructure & Integration
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seeWISE
ReviewMedical data review and visualisation — embedded into the data pipeline for cross-study safety review.
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CluePoints
RBQMKQI/KRI dashboards and statistical monitoring driving central oversight decisions.
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Pinnacle 21
CDISCCDISC validation built into every SDTM and ADaM release.
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Coursepath
LMSLearning management for ongoing GCP and platform-specific certifications — kept current across the team.
Operational questions sponsors ask
Can you take over an EDC study that is already in progress?
Yes — vendor migration is a regular part of our rescue practice. We move the build, transition the data, and revalidate without losing the audit trail or delaying the lock.
Do you cover ePRO and eCOA?
Yes — configuration, translation review, and validation for both patient- and clinician-reported outcomes, integrated with the EDC and the downstream SDTM mapping.
How do you handle vendor oversight?
We operate to ICH-GCP E6(R2/R3) sponsor-oversight expectations: KQI/KPI dashboards, monthly oversight reports, change-control review, and inspection-grade documentation. See our Vendor Oversight sub-service for detail.