PKY Secures Paradigm Contract & Expands Trial Capabilities

• TrialKey signs a services agreement with Paradigm for an independent evaluation of its Phase 3 osteoarthritis study.
• TrialKey will assess whether changes to study design, conduct, or analysis could have affected the interim results of Paradigm's Phase 3 trial.
• The agreement highlights TrialKey's expanded clinical trial design and assessment capabilities.

Pathkey.Ai Ltd, through its subsidiary TrialKey, has signed a services agreement with Paradigm Biopharmaceuticals Ltd to provide an independent evaluation of its Phase 3 osteoarthritis study. The agreement is valued at A$25,000 plus GST. TrialKey will assess the trial's design, conduct, and analysis to identify potential reasons for Paradigm's interim findings and evaluate whether alternative approaches could have affected the results. This engagement demonstrates a commercial application of TrialKey's assessment and planning offering to an existing late-stage clinical program. The work will assess regional differences, treatment exposure, and missing data, including scientifically justified alternative approaches to handling missing assessments.