Clinical Data Management (CDM) is critical to the success of clinical trials, ensuring that collected data is accurate, reliable, and compliant with regulatory standards. Our CDM services cover the full study lifecycle, from initial planning and setup to database lock and study closure. With a focus on quality and precision, we support protocol review, system validation, eCRF programming, and comprehensive documentation to lay a strong foundation for each study.
During the conduct and closeout phases, we manage data review, discrepancy handling, coding, and reconciliation activities to maintain clean and consistent data. Our team ensures smooth execution through timely reporting, quality checks, and regulatory-ready submissions. With experience across multiple therapeutic areas and study types, we provide tailored support to meet each sponsor’s unique requirements, ensuring efficient data management from start to finish.
Study Setup
- Protocol Review
- Project Plan & Timelines
- eCRF, edit check, role access control programing & validation
- Annotated CRF, Master CRF Casebook & ALS Generation
- Dictionary Setup (MedDRA, WHODD)
- Local Lab Setup
- User Acceptance Testing (UAT)
- Study Documentation (DMP & DRP)
- eCRF Completion Guidelines
- Vendor Management (Agreement & Setup)
- IxRS Integration Setup, Validation & go-live
Study Conduct
- User Request Management
- Data Review & Discrepancy Management
- Reports for Data Review & Metrics
- Periodic Quality Review & CAPA
- Medical Coding
- SAE Reconciliation
- Vendor Data Reconciliation (Central Lab, PRO, Images, Pharmacokinetics etc)
- Postproduction Changes/ Database Migration
- Data Submission for Interim & DSMB Analysis
Study Closeout
- Interim/ DSMB Analysis Readiness
- Final Review of Data Base & Issues Closure / Agreement
- Database Audit by QA
- Database Freeze, Lock and Documentation
- Data Conversion to SDTM or Sponsor Standards
- Study Closure / Sites Closure Documentation
- Study Archival / URL Decommissioning Support