Clinical Data Management & EDC Services
Our Clinical Data Management (CDM) services are designed to ensure high-quality, regulatory-compliant data that supports efficient clinical trial execution and reliable outcomes. Below is a comprehensive outline of our offerings:
Study Start-up
- Protocol Interpretation – Translating study protocols into CDM plans and system design.
- Document and Guideline Management:
- DMP – Data Management Plan
- eCCG – eCRF Completion Guidelines
- DTS – Data Transfer Specifications
- Study Set-up and Maintenance
- eCRF Design – Forms, fields, matrices, form/field dynamics, and derivations.
- User Acceptance Testing (UAT) – For eCRFs and edit check
- Edit Check Specification (ECS) – Preparation and programming.
- CDISC Standards Implementation – CDASH, SDTM.
- Risk-Based Data Management Planning
- Metadata Management
- Database Deployment
- Handling the Post-Production Changes
EDC Expertise
We offer extensive experience with leading EDC systems:
- Medrio, Medidata Rave, Veeva Vault, InForm, ClinCapture, iMednet, VieDoc, Octalsoft, Oracle Clinical, PICTS, Clinform
Study Conduct
- EDC and Data Entry Training – For site users and study teams.
- Ongoing Data Cleaning and Query Management
- Data Listings Review – Including protocol deviation review and data trend analysis.
- Reconciliation Activities:
- SAE Reconciliation
- External Data Reconciliation (e.g., labs, ECGs, imaging)
- Real-Time Data Monitoring Dashboards
- Data Visualization and Reporting (optional BI tools)
- Medical Coding
Study Closeout
- Final Data Review and Database Lock
- Database Unlock / Re-lock (as required)
- EDC Archival
- Data Export for Statistical Analysis and CSR
- Submission-Ready Data Packages:
- Define.xml
- Reviewer’s Guides
- Annotated CRFs