Data management and statistics

Cost-effectiveness and customized solutions are LCR’s main drivers in these areas. We strive to adapt the project to the client’s requirements as much as possible while keeping only the indispensable items in the budget. For non-GCP trials we are able to prepare extremely competitive budgets. Generally we offer:

Statistical planning

  • Power analysis and sample size determination
  • Statistical text in the study protocol
  • Statistical analysis plans

Statistical analysis

  • Final and interim data analysis, GCP and ICH E9 compliant
  • Statistical reporting

Data management

  • Both paper and eCRF solutions, GCP, EMA/INS/GCP/454280/2010,
    and 21 CFR Part 11 compliant
  • Data management plans
  • CRF design
  • Clinical database design and setup
  • Edit checks programming
  • Discrepancy and query management
  • Data cleansing
  • Database auditing
  • Data extractions, reports, and data transfers