data management consulting

In addition to providing data management services as one of our core competencies, ClinDatrix also guides sponsors and clinical trial facilities in establishing their internal data management capabilities.

Our data management experts offer consulting expertise in the following areas relating to the challenges of data management:

  • Establish internal data management departments including making recommendations for:
    • Data management organizational structure and job descriptions
    • Hardware and software evaluation, acquisition and validation
    • Generation and implementation of standard operating procedures
    • Productive and expedient data flow
  • Review and select data management equipment and service providers
  • Negotiate data management contracts
  • Select data collection methodology using “best fit” technology specific to the criteria of the project or trial
  • Prepare and/or review data management documentation to include any or all of the following: data management plan, quality control plan, edit (validation) specifications document, clinical data review manual, data management QC checklists and data management project binder
  • Set up and manage project to enable quality and on-time deliverables of accurate and complete databases, analyses and reports
  • Critically review protocol and case report form design to optimize accurate and timely data collection, database setup, data management and statistical and reporting activities
  • Define, create and maintain validated standardized data collection and data cleaning systems
  • Design and create chemical compound and/or program data repositories suitable for the conduct of integrated statistical summaries (ISS)