Empowering Data Precision. EDC & Data Management Solutions, Transforming Complex Information into Actionable Insights.
Extensive experience with best software in the Industry including iMedidata Rave, Veeva Vault, Viedoc, iMednet, etc Selection of the EDC system according to the Study Specifics, Sponsor Requirements, Study Budget, etc. Validation of the selected EDC system according to Regulatory Guidelines and custom URS.
Study Start-up
Conduct Phase
Database Lock
- Review of Protocol and other Study
Documents, CRF Development - Development of Data Management and
Validation Plans - Selection of EDC System
- Database set-up according to SDTM
- Validation of Clinical Database before GoLive
- Cleaning and Validation of Clinical data
- Query Management
- Medical Coding using MedDRA and
WHODrug Dictionaries - Serious Adverse Event Reconciliation
- Transfer and validation of external data
- Final Review and Validation of clinical data
- Delivery of clean datasets
- Full data management document package
to eTMF - Database Lock and Archiving