A full service Contract Research Organization

Offices in the San Francisco Bay Area and Sydney, Australia

Biometrics

Our Biometrics Department, comprised of Data Management, Statistical Analysis and Programming support provide an integrated and comprehensive approach to clinical data capture, analysis and presentation. Our team covers the full breadth of services required to successfully execute your study, including:

STATISTICAL ANALYISIS

  • Protocol development
  • Determining Primary(ies) and Secondary Endpoints to maximize success probability
  • Alpha Spending Scheme Planning
  • Sample size calculation
  • Statistical Analysis Plan
  • Analysis methods development
  • Regulator precedent review
  • Developing Phase I, II and III integration plan for NDA submissions
  • Developing ISS and ISE Statistical Analysis Plans
  • Ad-hoc analyses
  • Publications

CLINICAL DATA MANAGEMENT

  • CRF development
  • Develop Edit Checks
  • Database design and build in multiple EDC platforms
  • Integrating IWRS with EDC as needed
  • Database User Requirement Testing
  • Data Management and Quality plan development
  • Adverse Events and medication coding
  • Serious adverse event reconciliation
  • Query management
  • Manual listing review for data quality
  • Database freeze and lock
  • Support DSMB, Interim and DMC meetings

DATA AND SAFETY MONITORING BOARDS

  • Charter development
  • Meeting report (including interim efficacy analyses) preparation
  • Data presentation
  • Member participation

STATISTICAL PROGRAMMING

  • Randomization and IWRS development
  • Developing SDTM and ADaM Specification and datasets per CDISC standards
  • Define.xml files, Open CDISC report, Review Guide
  • Annotated TFLs
  • TLF programming
  • Complex cross-tabular edit checks
  • Data cleaning programming of key safety and efficacy endpoints
  • Submission-ready package
  • ISS and ISE Data Integration and Analyses
  • Safety report and IB support
  • Project reports

PHARMACOKINETICS AND PHARMACODYNAMICS ANALYSES

  • Non-compartmental analysis and reports using Phoenix WinNonLin
  • Biomarker evaluation and analyses
  • Relational analyses of the PKPD parameters to primary endpoints

REGULATORY COLLABORATION

  • Strategic direction recommendations
  • Briefing package preparation
  • Regulatory agency meeting statistical discussion and presentation
  • Regulatory submission-ready data, programming and analysis package
    Integrated summaries of safety and efficacy
  • CSR statistical authorship
  • New drug/device application and other report (eg, annual safety/IND reports) review and editing