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Data Management Expertise
Tech Observer’s dedicated Data Management experts provide accurate, regulatory-compliant clinical data solutions. Our systems, SOPs, and personnel are equipped to manage all 3 methods of data capture:
Paper
Fax, or
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EDC - Electronic Data Capture
Our data management services and procedures include:
Data Management Plan (Quality Control Guidelines)
Case Report Form (CRF) Design
Database design and Data Validation plan
Quality control testing of database
Data entry (double)
Data clarification, consistency/logic checks and querying
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Medical Coding - MedDRA, WHO - ART, COSTART, WHODRUG
Data Validation and Query Management
Central laboratory data import
Data lock, audit and export (SAS, ASCII, etc.)
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Database Documentation and Release
To ensure the integrity and accuracy of the study data, our Data Management Staff follow corporate QC and QA processes. Our QA process formally assesses compliance with corporate and study-specific SOPs.
Our Data Management platforms are based on Oracle® Clinical™. All of our systems and software platforms are fully validated and comply with ICH Guidelines and current US, EU and Canadian government regulations.
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201-489-7705 | 201-489-7709