Biometrics

Two scientists in lab coats and safety glasses reviewing data on a computer screen, discussing biometric analysis in a research environment.

Biometrics Services

Led by industry experts, Pharmaron provides quality biometrics services ranging from Phase I to Phase IV in a wide variety of therapeutic areas. We are a Medidata-accredited vendor and our team is highly proficient with Rave EDC, Balance RTSM, CTMS and eTMF and CDISC standards including CDASH, SDTM and ADaM.

Data Management

  • Case Report Form (CRF, eCRF) design and review
  • Randomized trial and drug supply system design
  • Database design, build, test, maintain and close-out
  • Double data entry and comparison of paper-form data
  • Data verification and validation management
  • Data transfer
  • Medical coding
  • SAE and External data reconciliation
  • Local lab range management
  • Quality assurance and data management audit
  • EDC systems
A healthcare professional reviews clinical data on paper and a computer screen displaying various metrics and tables in a modern office setting.

Statistical Analysis and Programming

  • Power/sample size calculation
  • Protocol development and statistical methodology development
  • Adaptive design methodology implementation
  • Trial design input and simulation
  • Statistical Analysis Plan (SAP) and mock up shells development
  • Randomized schedule development and randomization list generation
  • Development of study data tabulation model (SDTM) datasets
  • Development of analysis datasets (ADaM) and derivation
  • Creation of tables, listings, and figures (TLF)
  • Support of publication and exploratory analysis
  • Interim analysis
  • Data Monitoring Committee (DMC) related statistical activities
  • Integrated summaries of safety and efficacy (ISS/ISE)
  • Annual or periodic safety reporting
  • Clinical study report review
  • Statistical analysis report