Clinical Data Management Services

Clinical Data Management

• Documentation (Data Management Plan, Edit Check Specification)
• Database User Acceptance Testing
• Data Entry
• Edit Check User Acceptance Testing
• Discrepancy and Query Management
• Forms Tracking
• Data Lock

Thesaurus Management

• Documentation (Thesaurus Management Plan)
• MedDRA and WHOdrug classification
• Consistency review
• AE/SAE reconciliation

Laboratory Data Management

• Documentation (Lab Data Management Plan, Central Lab Data Transfer Plan)
• Local Reference Range Collection and Entry
• Applying ranges to lab test questions
• Conversion to reported units

CRF Design

• Paper CRF design
• CRF completion instruction
• CRF printing and distribution

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