Case Studies
Expert-Led.
Clinically Grounded.
Phase III Non-small cell lung cancer (NSCLC)
We provided consultancy for a Phase III NSCLC trial. Using TrialKey, we applied data-driven adjustments that improved the modelled probability of success from 62% to 66%.
We streamlined inclusion and exclusion criteria from 16 to 11. This improved recruitment efficiency and reduced patient dropouts as each dropout costs over USD $19,000 to replace.
We cut secondary endpoints from 13 to 7. This reduced data collection and analysis complexity, and improved focus on meaningful clinical outcomes.
We optimised touchpoints, capping both primary and secondary at 10. This reduced patient burden, site workload, and monitoring costs—without compromising trial integrity.
Site count was cut from 250 to 100, focusing on high-performing locations. This reduced fixed overhead and resource drag. Low-yield countries like Korea and Australia were replaced with regions showing higher recruitment potential, including China, Japan, and Russia.
All recommendations were based on 100,000 simulations and benchmarking against 397 NSCLC trials.
Brain Vectory VRPME™ Technology
We partnered with Brain Vector to optimise the clinical trial design for their VRPME™ (Virtual Reality Positive Memory Enhancement) neuro device, aimed at treating mild to moderate depression. TrialKey simulated the study 20,000 times using real-world data and advanced AI modelling. This process led to a predicted 70% probability of success for the final design.
The simulation recommended a single-group, open-label structure, with an enrolment target of 150–200 patients and a trial duration of 12–26 weeks. These parameters were significantly leaner than Brain Vector’s initial assumptions and provided a strong balance between statistical power and operational feasibility.
Beyond study structure, TrialKey helped define key trial components: the intervention model, blinding strategy, inclusion and exclusion criteria, and both primary and secondary endpoints. The platform’s eligibility model supported the selection of recruitment-friendly criteria without diluting outcome relevance. TrialKey also optimised the number of sites and touchpoints to minimise site burden and improve patient retention.
To guide commercial positioning, TrialKey produced an investor report that highlighted the trial’s design rigour, risk mitigation strategies, and expected outcomes. In parallel, we co-developed a solus EDM campaign with Brain Vector, targeting neurologists across Australia and New Zealand. The campaign supported recruitment, brand visibility, and awareness of the VRPME™ trial.
TrialKey’s AI engine also identified and benchmarked over 250 comparable neuro device and mood disorder trials, ranking them by success probability, duration, and design similarity. This competitive intelligence provided Brain Vector with the data to position their trial confidently within the market.
This collaboration helped Brain Vector de-risk their clinical investment, improve trial efficiency, and strengthen their outreach. By applying TrialKey, they moved forward with a design backed by rigorous modelling, real-world benchmarking, and strategic clarity.
Brain Vectory VRPME™ Technology
We partnered with Brain Vector to optimise the clinical trial design for their VRPME™ (Virtual Reality Positive Memory Enhancement) neuro device, aimed at treating mild to moderate depression. TrialKey simulated the study 20,000 times using real-world data and advanced AI modelling. This process led to a predicted 70% probability of success for the final design.
The simulation recommended a single-group, open-label structure, with an enrolment target of 150–200 patients and a trial duration of 12–26 weeks. These parameters were significantly leaner than Brain Vector’s initial assumptions and provided a strong balance between statistical power and operational feasibility.
Beyond study structure, TrialKey helped define key trial components: the intervention model, blinding strategy, inclusion and exclusion criteria, and both primary and secondary endpoints. The platform’s eligibility model supported the selection of recruitment-friendly criteria without diluting outcome relevance. TrialKey also optimised the number of sites and touchpoints to minimise site burden and improve patient retention.
To guide commercial positioning, TrialKey produced an investor report that highlighted the trial’s design rigour, risk mitigation strategies, and expected outcomes. In parallel, we co-developed a solus EDM campaign with Brain Vector, targeting neurologists across Australia and New Zealand. The campaign supported recruitment, brand visibility, and awareness of the VRPME™ trial.
TrialKey’s AI engine also identified and benchmarked over 250 comparable neuro device and mood disorder trials, ranking them by success probability, duration, and design similarity. This competitive intelligence provided Brain Vector with the data to position their trial confidently within the market.
This collaboration helped Brain Vector de-risk their clinical investment, improve trial efficiency, and strengthen their outreach. By applying TrialKey, they moved forward with a design backed by rigorous modelling, real-world benchmarking, and strategic clarity.
“Working with TrialKey has been transformative for Brain Vector. The insights from their comprehensive report have significantly reduced costs and time while providing invaluable data that sharpened our focus on the most impactful areas. This collaboration has laid a strong foundation for our clinical trial and our broader mission to enhance mental health care.”
Phase III Knee osteoarthritis
We provided consultancy work for a knee osteoarthritis Phase 3 study. Using TrialKey, we optimised the predicted probability of success to 78% by identifying the optimal enrollment window (350–482 patients). In this case, we reduced the original recruitment target from ~600 to 390 patients, which aligned with the exponential increase of probability of success.
This reduction in sample size resulted in projected savings of approximately USD $6.8M, based on a per-patient cost of AUD $50,000
Request a Sample Report
Request a Sample Report
Official Partner Of
Leveraging the TrialKey AI Advantage
Proprietary Dataset
We've spent over two years curating a unique and extensive dataset, a complex task that required significant effort and expertise, tailored specifically to solve this market problem.
Trial Analysis
While Clinicaltrials.gov reports outcomes for less than 20% of trials, we've expanded this by incorporating data from press releases and peer-reviewed journal articles. Using a scalable LM approach able to categories success/failure
Proprietary Feature Set
Our feature set combines both structured and unstructured data, enabling us to answer highly specific questions, such as determining the level of disease progression in motor neuron disease that gives the best chance of clinical success — a task only possible through advanced language models.
Subject Matter Expertise in Modeling
With deep expertise in data modeling, we've achieved higher accuracy compared to competitors, delivering more reliable insights.
AI-Driven Trial Design, Supervised by Medical Experts
Medical experts are integral to every stage of TrialKey’s development. From design to execution, their expertise in clinical research–including drug safety, patient care, pharmacology, clinical operations, and biostatistics ensures that our solutions are tailored to meet the specific needs of clinical trials while maintaining scientific rigor
