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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

  • EDC - Electronic Data Capture

Service Partners

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

  • Medical Coding - MedDRA, WHO - ART, COSTART, WHODRUG

  • Data Validation and Query Management

  • Central laboratory data import

  • Data lock, audit and export (SAS, ASCII, etc.)

  • Database Documentation and Release

Service Partners

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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