Our Service > Clinical Data Management

At Tech Observer we use fully validated 21CFRPart11 Compliant Oracle® Clinical™ Software for paper based studies and Oracle RDC System for all EDC Studies (eCRF). Tech Observer’s dedicated Data Management experts provide accurate, regulatory-compliant clinical data solutions as per the ICH-GCP compliant SOP’s.

Our in-house data management unit set up at our LATAM headquarters Sao Paulo office provides end to end Data Management solutions:

• Data Management/Validation Plan
• CRF/eCRF Design
• Database Design & Testing
• Data entry (double)
• DCF Generation, Querying and Resolution
• Medical Coding – MedDRA & WHODRUG
• Data Validation and Query Management
• Database Lock & Audit