Full Data Management Services
Data management is essential to the overall clinical research function. Assuring the overall accuracy and integrity of the clinical trial data is the core business of the data management function.
Clinical Data Management services
Study Startup
- Protocol Review
- CRF Creation
- Data Management Plan
- Database Build:
1. eCRF Specification
2. eCRF Programming
3. Data Validation Plan
4. Edit/SAS Check programming
5. Dataset extraction and review
6. eCRF Completion Guideline
7. Data Review Plan
- Database Go-Live
- Site Trainings
Conduct Phase
- Data entry and validation (single and double data entry)
- Data Cleaning
- Query Management
- SAE Reconciliation
- External data integration, verification and reconciliation
- Data Transfer Agreement(s) (DTAs)
- Medical Coding using WHODrug and MedDRA dictionaries
- Data Export and Reporting
Database Lock
- Database Finalization
- Query resolution
- Obtaining eCRF eSignatures
- SAE reconciliation
- Medical Coding approval
- Documentation finalization
- Data Export and CDASH compliant deliverables
- Database Lock and Archival
OUR EXPERTISE IN EDC TECHNOLOGIES
NoyMed EDC
NoyMed EDC is a multi-functional tool which incorporates the best experience of the leading Electronic Data Captures.
Strong experience in EDC technologies:
