Quanticate’s support focused on building a reliable evidence pipeline that could keep pace with an adaptive design, while maintaining the quality standards expected for oncology development.
Clinical Data Management and data readiness
Quanticate’s Clinical Data Management (CDM) team established a framework to support accurate capture of complex, time-sensitive data from multiple clinical sites. This included:
- Standardised data collection and validation rules to reduce variability across centres.
- Ongoing data cleaning workflows designed for frequent interim checks, not end-of-study reconciliation.
- Centralised quality checks to identify outliers, missing data patterns, and timing issues early, before they affected key pharmacokinetics (PK), pharmacodynamics (PD), or testosterone endpoints.
- Data harmonisation processes to ensure laboratory results and biomarker measurements could be integrated cleanly with dosing, safety, and clinical outcome data.
Statistical Programming for decision-ready insight
Quanticate’s Statistical Programming specialists helped the sponsor translate complex incoming data into clear, decision-ready outputs. The focus was not only on producing tables and listings, but on enabling confident interpretation at key review points:
- Programming analysis datasets that aligned pharmacokinetics (PK) sampling, pharmacodynamics (PD) measures, testosterone values, and dosing records to the correct time windows.
- Producing comparative outputs that supported dose-level evaluation on both suppression performance and tolerability indicators, including injection site reactions and systemic safety measures.
- Integrating safety biomarkers, including cardiovascular markers, in formats that enabled consistent tracking over time and efficient review of potential safety signals.
- Implementing checks and derivations that improved consistency across sites and strengthened the reliability of interim summaries.
