The Biometrics Pathway in 7 Steps

From raw data to regulatory submission, you deserve a biometrics partner you can trust to provide insight and expertise at every step.

1. Data Collection
   • Goal: Design instruments and gather data that support your endpoints
   • What to Look For: A collaborative partner who understands the nuances of your protocol
2. Processing & Extraction
   • Goal: Provide clean, accurate data for analysis
   • What to Look For: Timely execution supported by robust systems and processes
3. SAP/TLF Specifications
   • Goal: Establish a clear plan for analysis and outputs
   • What to Look For: Translation of your study protocol into specific, compliant objectives
4. Data Standardization
   • Goal: Alignment with CDISC data standards
   • What to Look For: Strong understanding of data standards and ability to scale quickly
5. Statistical Report Generation
   • Goal: Reporting of primary/secondary endpoints and comprehensive safety summaries, in line with SAP   
   • What to Look For: Expertise in translating your research question into analysis
6. Statistical Review
   • Goal: Review of analysis by the biometrics team and sponsor
   • What to Look For: Clear communication and ability to address necessary comments
7. Submission
   • Goal: Complete submission package
   • What to Look For: Thorough understanding of and adherence to regulatory requirements

When you choose an experienced partner and set a strong foundation, your full biometrics pathway becomes seamless.