Clinical Data Management Services

Robust study set-up is the foundation of clean data. We work with sponsors and CROs from the earliest stages to ensure data management considerations are embedded in the protocol and study design — before the first patient is enrolled.

Key activities

• Protocol review and CDM input
• Data Management Plan (DMP) authoring and review
• CRF design and annotation
• Data flow and transfer agreement review
• Study-specific CDM timeline and resource planning

We design, build and configure EDC databases that are fit for purpose, thoroughly tested, and validation-ready. Our EDC-agnostic approach enables us to support clinical studies across different platforms, aligned with sponsor requirements and applicable regulatory expectations.

Key activities

• EDC database design and specifications
• Database build and configuration
• Edit check and validation programming
• User Acceptance Testing (UAT) execution and sign-off
• Database release and go-live support

We provide ongoing EDC administration and clinical systems support throughout the study lifecycle. We help maintain database integrity as studies evolve, managing protocol amendments, database updates and revalidation while ensuring timely user support and smooth study operations.

Key activities

• EDC system administration and user management
• Protocol amendment implementation
• Database modification and re-validation
• Ongoing edit check maintenance
• User training and helpdesk support

We review clinical data to identify and resolve discrepancies, maintain data quality and ensure audit readiness. All cleaning activities are documented, traceable and aligned with the DMP, protocol and applicable regulations.

Key activities

• Ongoing data review against protocol and edit checks
• Discrepancy identification and tracking
• Data cleaning and resolution management
• Listings and data review report generation
• Data cleaning status reporting for study teams

We manage the complete query lifecycle—from generation and site follow-up to resolution and closure—ensuring data quality and compliance with protocol requirements and sponsor SOPs.

Key activities

• Query generation and issuance to sites
• Query tracking and ageing management
• Site follow-up and escalation support
• Query resolution review and closure
• Query metrics and status reporting

We provide medical coding using current MedDRA and WHO Drug dictionaries, supporting accurate safety reporting, pharmacovigilance and regulatory submissions.

Key activities

• MedDRA coding of adverse events and medical history
• WHO Drug coding of concomitant medications
• Coding conventions development, documentation and maintenance
• Coding query management and resolution
• Safety database reconciliation

We reconcile clinical data across EDC, safety, laboratory and external data sources to ensure consistency, accuracy and completeness throughout the study.

Key activities

• EDC to safety database reconciliation
• Laboratory data reconciliation and data transfer review
• External data vendor reconciliation
• Discrepancy identification and resolution tracking
• Reconciliation documentation and sign-off

We develop and maintain essential CDM documentation throughout the study, supporting consistent processes, traceability, audit readiness and regulatory compliance.

Key activities

• DMP authoring and maintenance
• CDM guidelines and working instructions
• SOP authoring and review support
• Trial Master File (TMF) CDM documentation
• End-of-study CDM report preparation

We coordinate pre-lock reviews, database lock execution and post-lock deliverables to support an accurate, documented and compliant study close-out.

Key activities

• Pre-lock data review and outstanding query resolution
• Lock readiness assessment and sign-off
• Database lock execution and documentation
• Post-lock data extracts and transfer
• Close-out reporting and archival support

We provide flexible CDM consulting and resourcing tailored to project needs, offering specialist expertise, strategic guidance and embedded support to sponsors and CROs.

Key activities

• CDM process review and improvement consulting
• Embedded CDM resource for sponsor or CRO teams
• Study-specific CDM strategy and planning
• Regulatory inspection preparation support
• CDM vendor oversight and quality review