BioStatistics & Data Management

Biostatistics & Data Management

We have experienced staff who are well-versed in the planning of clinical trials as well as the analysis of data. We can provide expertise for whatever level of support you need – including the ability to support the management of study data.


Statistical Support

  • Review or author protocol sections with respect to statistical methodology and data management
  • Create randomization schedules.
  • Author protocol-specific Statistical Analysis Plans (SAPs) including creation of table shells and listings
  • Conduct analyses per the SAP using SAS
  • Provide interpretations from data analyses to be incorporated into reports or presentations

Data Management

  • Creation of data management plan (DMP)
  • Tracking of regulatory documents
  • Creation of integrated payment rules and creation of check requests for site payment of enrollment or form completion
  • Working with study coordinators to assure scheduling of protocol-required follow-up visits
  • Reviewing data entry and assessing necessary database changes to fields and edit checks
  • Reviewing data and adding or closing queries per the protocol and DMP