Cogstate (CGS) Study Update summary

Partnership overview and strategic positioning

• Cogstate and Medidata have formed a strategic partnership to deliver advanced digital cognitive assessments and data solutions for clinical trials, particularly in central nervous system (CNS) diseases.

• Medidata is a leading technology provider in clinical trials, supporting over 8,000 ongoing studies and capturing 200 million data points daily.

• The partnership leverages Medidata's global platform and Cogstate's expertise in digital cognitive testing to address growing R&D investment in CNS indications.

• The joint offering is positioned as a best-in-class, integrated solution for sponsors, enhancing operational efficiency and data quality.

• Early signs show strong pipeline growth, industry recognition, and increasing deal wins for the partnership.

Technology, data, and AI integration

• Medidata has consolidated 35 products into three core experiences: patient, data, and study, streamlining trial operations and patient engagement.

• The platform supports decentralized trials, enabling remote data capture and reducing patient burden through mobile and wearable technologies.

• Medidata's AI program utilizes a unique, clean dataset from over 10 million clinical trial patients to optimize trial design and execution.

• Cogstate's digital cognitive tests are scientifically validated, scalable, and accepted by global regulators, supporting both in-clinic and remote use.

• The partnership aims to further integrate AI for advanced endpoint data quality and seamless workflow delivery.

Expansion into new indications and operational excellence

• Cogstate is expanding beyond Alzheimer's into rare neurodevelopmental disorders and psychiatric indications, including gene therapy and psychedelic trials.

• The company has developed new clinical endpoints and digital batteries, validated with regulatory alignment, for rare disease trials.

• In psychiatric trials, Cogstate offers advanced data visualization, algorithmic monitoring, and central rating to ensure data quality and blinding.

• The operational infrastructure includes over 300 clinicians in 50 languages, supporting global late-phase programs.

• Investments continue in AI-driven training, monitoring, and talent acquisition to maintain scientific leadership and support smarter trial design.