The Challenge

The client needed support across the entire clinical pipeline—from preclinical studies to Phase I and Phase II trials—to analyse omics data, advise on statistical methods and interpret results. They wanted standardised analyses and interactive reports to facilitate decision‑making.

Our Approach

We engaged stakeholders, provided statistical and data management support and offered continuous advisory throughout preclinical and clinical development.

• Stakeholder engagement & planning: Collaborated with the client to understand biological questions, providing weekly updates and standardised reports on more than twenty preclinical datasets.
• Statistical and data‑management support: Advised on statistical plans, quality criteria and data management; developed standardised analysis plans and interactive reports; and conducted QC and gene‑signature analysis for Phase I and II clinical data.
• Continuous advisory & flexibility: Offered ongoing guidance, set up data‑transfer protocols and performed proof‑of‑concept analyses to maintain flexible, solution‑driven insights.

The Outcome

• Delivered pre‑processing, QC and transcriptomic analyses using rigorous statistical models.
• Identified gene signatures to test target engagement and efficacy and documented all methods to meet clinical standards.
• Produced interactive reports and ensured strong communication with the client.
• Provided statistical support for developing trial analysis plans and flexible advice across the development pipeline.

Why It Matters

Integrating bioinformatics and statistical support across the pipeline enables therapeutic companies to extract maximum value from data and make confident decisions. This case illustrates how continuous collaboration and rigorous analysis drive successful clinical development.