Biostatistics

For biostatistics services, Ora partners with our sister company, Statistics & Data Corporation (SDC). Since 2005, Ora and SDC have worked together on more than 100 phase I-IV studies, giving SDC unparalleled experience in designing, building, analyzing, and defending ophthalmic trials.

Extensive libraries of standard ophthalmic Table, Listing, & Figure (TLF) summaries
Proficiency in converting ophthalmic data into SDTM standards
Experienced, driven project teams require minimal oversight from Sponsors
Seamless interaction between SDC and Clinical Operations teams at Ora

The biostatistician plays a key role in the planning and preparation of any study. From helping to design a cost-effective, optimal study, and providing the relevant statistical input on the study protocol to representation at regulatory meetings, our team is here to support you every step of the way. Key advantages to partnering with Ora/SDC for biostatistics services include the following:

  • Extensive libraries of standard ophthalmic Table, Listing, & Figure (TLF) summaries
  • Proficiency in converting ophthalmic data into SDTM standards
  • Experienced, driven project teams require minimal oversight from Sponsors
  • Seamless interaction between SDC and Clinical Operations teams at Ora
  • Dedication to timelines - over 98% on-time delivery of key milestones since 2011.
  • Rapid turnaround of top-line results consistently delivered within 3 days of database lock and full results delivered within 2 weeks of database lock
  • Comprehensive experience in communicating with the FDA ophthalmic division, via face-to-face meetings and teleconferencing as well as collaborating on the preparation of briefing packages and responses
  • SDC’s biostatistics leadership team brings extensive ophthalmic experience
    • Dale W. Usner, PhD, President - approximately 20 years leading and executing clinical trial research, including 10+ years in ophthalmic pharmaceuticals and devices
    • Kirk Bateman, MS, Director of Biostatistics – 12+ years leading and executing clinical trial research, including approximately 10 years in ophthalmic pharmaceuticals and devices 

SDC’s Biostatistics Services Include:

  • Power and Sample Size Calculations
  • Study Design & Endpoint Development
  • Client Representation at Regulatory Agency Meetings
  • Randomization Schedule Preparation
  • Statistical Analysis Plan Development
  • Interim Analysis Planning
  • Data Monitoring Committee Planning and Reporting
  • SAS Programming and Independent Validation of TLFs
  • Meta Analysis/Post Hoc Analysis
  • Pharmacokinetic (PK) Analysis
  • Review and Support for Publications
  • Integrated Summaries of Safety & Efficacy (ISS/ISE)
  • CDISC SDTM and ADaM Standards
  • SAS-Derived Data Review and Interpretation Tools (i.e. Patient Profiles & P-Value Summaries)