Our biostatisticians have analyzed more ophthalmic data than any other group in the world, so they are able to discover the key pieces of data that often elude less experienced biostatisticians.
Ora's bioinformatics division, Statistics & Data Corporation (SDC), was founded under the belief that there is often valuable information trapped in study data that current methods of biostatistics cannot easily identify.
SDC statisticians come from diverse backgrounds in biostatistics, quality and reliability engineering, and Six Sigma methodology. Working together, they are able to provide "outside the box" thinking and analysis to improve your clinical study design and results. We invite you to discover how our top-tier statisticians can empower you with the most efficient pathways to drug approval. Our team of experts shares an in-depth understanding of numerous key therapeutic areas, as well as their unique regulatory environments. Our team also possesses a deep knowledge of both the evaluation histories of similar past studies, as well as the distinct statistical issues that affect these disparate therapeutic pathways.
SDC’s project-level biostatistics services include:
- Power and Sample Size Calculations
- Randomization Schedule Preparation
- Protocol Input and Development
- Statistical Analysis Plan Development
- Adaptive Trial Design & Statistical Modeling
- Interim Analysis Planning
- Statistical Programming and Validation utilizing CDISC Standards
- Validated SAS Environment hosted in a Tier 3 Hosting Facility
- Analysis Methodology Development and Evaluation
- Patient Classification into Analysis Sets
- Independent QC of Analysis and Statistical Programming through Peer Review
- Statistical Reporting
- Data Monitoring Committee (DMC) and Data Safety Monitoring Board (DSMB) participation
- Meta Analysis/Post Hoc Analysis
- Review and Support for Publications
- Client Representation at Regulatory Agency Meetings
- ISS/ISE – (Integrated Summary of Safety/ Integrated Summary of Efficacy)
- Blind Review
- Pharmacokinetic (PK) Analysis