Data Management & Statistics

Fast delivery of high quality and meaningful data means that you can make well informed decisions earlier in the trial. This also ensures patient protection and reliable trial results.

Data Management 

We leverage quality processes and project specific data management documentation to produce accurate and robust clinical databases for analysis and reporting.  Our services include: 

  • Data Management Plan development
  • Case Report Form (CRF)/eCRF design and review
  • Data Validation specification (Data Validation Plan)
  • Edit checks programming and testing
  • Ongoing data review and query management
  • Customized status reports/trackers

Statistics

genae statisticians are experienced in the statistical analysis of clinical trial data in general and in advanced statistical analysis methods for power calculations, interim & final statistical analysis and stopping rules in specific. Our ability to link databases from the core lab with the trial databases results in an unsurpassed data pool for strategic, scientific and marketing decisions.

Medical coding

  • Medical coding of Adverse Events (MedDRA)
  • Reconciliation of Serious Adverse Events and other data

How can we help you?

Want to hear more about our services or how we can support your project? Feel free to contact us with any questions you may have.

Contact us