What we offer
Clinical Data Management Services
From study start-up to database lock, we provide the expertise, processes, and tools to keep your clinical data clean, compliant, and analysis-ready.
Data Management Planning
A solid Data Management Plan is the foundation of every successful study. We work closely with your team to develop comprehensive, protocol-specific DMPs that define data flows, responsibilities, timelines, and quality standards.
- Protocol review and data flow mapping
- DMP authoring and version control
- Regulatory alignment (ICH E6, FDA, EMA)
- Stakeholder review and sign-off coordination
Database Build & Validation
We design, build, and validate EDC databases that are robust, audit-ready, and aligned with your protocol. Our validation approach meets 21 CFR Part 11 and GAMP 5 requirements.
- CRF design and annotation
- EDC system build (Medidata Rave, Oracle InForm, REDCap)
- Edit check programming and testing
- Validation documentation (IQ/OQ/PQ)
Medical Coding
Accurate medical coding is critical for safety reporting and regulatory submissions. Our experienced coders apply MedDRA and WHO Drug dictionaries with rigorous quality review at every step.
- Adverse event coding with MedDRA
- Concomitant medication coding with WHO Drug
- Coding conventions and guidelines authoring
- Dictionary upgrade management
Data Cleaning & Lock
We manage the full data review cycle — from query generation through resolution to database lock — ensuring your data is complete, consistent, and ready for statistical analysis.
- Data review and discrepancy management
- Query generation, tracking, and resolution
- SAE reconciliation
- Database lock and transfer to biostatistics
Data Management Oversight
Need senior oversight without a full-time hire? We provide experienced DM leadership to review deliverables, manage CRO performance, and ensure your study stays on track.
- CRO and vendor oversight
- DM deliverable review and sign-off
- Risk-based data review strategy
- Metrics reporting and escalation management
DM Consulting & Training
We offer targeted consulting and training to help your in-house team build capability, improve processes, and adopt best practices in clinical data management.
- SOP and process development
- DM system selection and implementation support
- Staff training and mentoring
- Audit readiness reviews
AI Software — by Dileas CS LtdAI-powered regulatory intelligence
Logic Line is our proprietary AI software platform built specifically for the clinical research and regulatory environment. It retrieves, analyses, and interprets regulatory guidance — delivering structured, cited answers your team can act on immediately.
Regulatory retrieval
Queries a curated knowledge base and returns precise answers with structured source citations and answer-status metadata.
Inspection intelligence
Analyses inspection-relevant queries against current regulatory expectations, flagging risk areas before they become findings.
SOP & gap review
Maps your SOPs against current guidance, highlights discrepancies, and generates a structured gap report automatically.
Built-in guardrails
Medical, legal, and privacy-conscious guardrails ensure every response is appropriate for high-stakes regulatory use.
Data Governance Platform — by Dileas CS LtdTransforming Data Integrity, Compliance, and Operational Efficiency
IDRP is our compliance-driven, AI-supported data governance system designed for pharmaceutical, biotech, and clinical research organisations. It centralises, structures, and monitors all critical data activities — ensuring every process, document, and decision is audit-ready, traceable, and aligned with global regulatory expectations.
Centralised oversight
A single dashboard view across all studies, vendors, and data streams — real-time visibility into data status, issues, and milestones.
Audit-ready compliance
Every action and decision is timestamped and stored in an immutable audit trail aligned with 21 CFR Part 11 and ICH E6(R2).
Risk-based governance
Automated risk scoring flags high-priority issues before they become inspection findings — proactive quality management.
Operational efficiency
Streamlined workflows and automated reporting reduce administrative overhead and keep studies on schedule and on budget.
Our approach
How we work with you
We believe good data management is about more than ticking boxes. It's about building a trusted partnership with your team.
Flexible engagement
We adapt to your study needs — whether that's full-service DM support, targeted expertise for a specific phase, or senior oversight of your existing team.
Regulatory rigour
All our work aligns with ICH E6(R2), FDA, and EMA expectations. We keep your data inspection-ready from day one.
Clear communication
You'll always know where your data stands. We provide regular status updates, transparent metrics, and proactive escalation when issues arise.
Not sure what you need?
Tell us about your study and we'll recommend the right level of support. No obligation.