Data Management & Biostatistics

Data management

Medelis uses the latest technologies for electronic data capture, management and communications. Of course we can also use paper-based data collection when appropriate. Our services include:

  • Case report form design
  • Database design and creation
  • Data entry
  • Data validation
  • Medical coding of adverse events and medical histories
  • Database lock
  • Data transfer

Biostatistics analysis and reporting

Medelis provides a complete array of biostatistics analysis and reporting, including:

  • Sample size calculations
  • Randomization schemes
  • Study design & protocol development
  • Statistical analysis plans
  • Statistical programming using SAS
  • Data conversion
  • Statistical tables and data listing for clinical study reports (CSRs)
  • Statistical reports
  • Statistical consulting
  • Statistical representation at FDA meetings