Case studies
From research to practice: AI innovations implemented and validated in real clinical trial settings.
Operational Development of Digital Twin Technology in a Phase 2 Parkinson’s Disease Trial
For a top 10 global pharmaceutical company
Context
Qairnel collaborated with a top-10 global pharmaceutical company to deploy its digital twin technology during an ongoing Phase 2 clinical trial in Parkinson’s disease.
The study was a large, multicenter, randomized, placebo-controlled trial evaluating a small molecule therapy. As is typical in Parkinson’s disease development, the sponsor faced challenges related to disease heterogeneity and variability in clinical outcomes.
The objective of the collaboration was not exploratory research, but operational integration — embedding prognostic modeling into real-time clinical development workflows and decision-making processes.
Challenge
The sponsor needed to determine whether advanced prognostic modeling could be deployed under real-world development constraints, including:
- Tight timelines aligned with an active Phase 2 trial
- Use of blinded patient data
- Integration within the sponsor’s secure infrastructure
- Direct collaboration with the biostatistics team
- Delivery of validated covariates suitable for formal statistical analysis
Unlike retrospective analyses, this required execution at production level, supporting decision-grade outputs in parallel with ongoing trial activities.
Approach
Qairnel acted as an embedded execution partner, delivering end-to-end operational deployment of its digital twin technology:
- Built and validated a Parkinson’s disease digital twin using proprietary Course Map AI
- Completed model training, cross-validation, and quality control within one week
- Deployed the model directly into the sponsor’s internal environment
- Conducted dry runs to ensure reproducibility and system integration
- Processed and harmonized blinded baseline patient data
- Delivered two validated prognostic covariates aligned with sponsor-defined endpoints
- Provided ongoing methodological support to the sponsor’s biostatistics team
This work was completed within less than one month from contract signature, demonstrating rapid industrial-scale execution.
A key differentiator was the interactive workflow, where Qairnel’s outputs were directly incorporated into the sponsor’s ongoing analyses-enabling real-time feedback, alignment, and decision support.
Outcomes
The collaboration successfully demonstrated that:
- Digital twin–derived covariates can be rapidly deployed and validated
- Advanced modeling can be integrated into sponsor infrastructure
- Outputs can be used in real-time Phase 2 decision-making
- External partners can function as embedded analytical collaborators
Importantly, Qairnel’s work was conducted independently of the trial outcome, reinforcing the objectivity and credibility of the approach.