Medidata and Menarini Group Expand AI-Powered Partnership to Accelerate Oncology Clinical Trials
Key Insights
Medidata and The Menarini Group (search) have expanded their 14-year partnership to deploy AI Study Build technology, reducing clinical trial startup time from months to weeks.
Stemline Therapeutics (search), Menarini's oncology subsidiary, will leverage AI-driven workflows to independently build and launch oncology studies using data from over 38,000 trials.
The partnership aims to accelerate the delivery of transformational cancer treatments to patients by modernizing the trial lifecycle from protocol to patient enrollment.
Medidata, a Dassault Systèmes (search) brand and leading provider of clinical trial solutions, has announced a strategic expansion of its partnership with The Menarini Group (search) and its wholly-owned subsidiary Stemline Therapeutics (search) to deploy AI Study Build technology for accelerating oncology clinical trials. The collaboration builds upon a 14-year relationship and represents a significant transition toward AI-driven clinical research workflows.
AI-Powered Clinical Trial Acceleration
The expanded partnership centers on Medidata's AI Study Build technology, which enables Stemline to leverage a vast clinical dataset of more than 38,000 trials to automate study configurations. This technology reduces the time between protocol finalization and trial startup from months to weeks, addressing the urgent needs of cancer patients awaiting new treatment options.
The AI Study Build platform provides three key capabilities: rapid study startups at unprecedented pace, internal agility empowering Stemline to build and launch future oncology studies independently, and stronger oncology research capabilities that deliver high-quality data faster to meet urgent cancer research requirements.
"Stemline is deepening its commitment to advancing oncology research by embracing our established AI foundation and latest AI Study Build capabilities," said Wayne Walker, senior vice president, Data Experience, Medidata. "Stemline's commitment to adopting Medidata AI-powered technologies sets a high bar for how sponsors can independently harness a unified platform to accelerate the delivery of new therapies for patients."
Strategic Impact on Oncology Research
The announcement follows Stemline's milestone achievement of launching its first oncology study entirely in-house using the Medidata Data Experience. This transition to unified, AI-driven workflows represents a modernization of the trial lifecycle from protocol development to patient enrollment.
Elcin Barker Ergun, CEO of The Menarini Group (search), emphasized the innovation focus driving the partnership: "Innovation is at the core of our mission to bring transformational treatments to patients, and we recognize the impact of Medidata AI to further streamline our workflows. Our expanded partnership with Medidata supports our internal expertise, enabling us to advance crucial research and reflecting the urgency of our team in bringing new options to patients as quickly and safely as possible."
Building on Established Collaboration
The expansion builds upon The Menarini Group (search)'s long-standing utilization of the Medidata platform, including Medidata Rave EDC and Medidata eCOA for managing end-to-end clinical study cycles. The move to AI Study Build marks a significant technological advancement, combining Menarini's clinical expertise with Medidata's established AI and Data Experience leadership.
Medidata brings over 25 years of technological innovation across more than 38,000 trials involving 12 million patients to the partnership. The platform serves more than 1 million registered users across approximately 2,300 customers, offering industry-leading expertise and analytics-powered insights backed by one of the largest clinical trial datasets in the industry.
Stemline's Oncology Portfolio
Stemline Therapeutics (search) operates as a commercial-stage biopharmaceutical company focused on transformational oncology treatments. The company commercializes elacestrant, an oral endocrine therapy for ER (search)-positive, HER2 (search)-negative, ESR1-mutated advanced or metastatic breast cancer, and tagraxofusp-erzs, a CD123 (search)-targeted therapy for blastic plasmacytoid dendritic cell neoplasm. Additionally, Stemline markets selinexor, an XPO1 (search) inhibitor for multiple myeloma in Europe.
The company maintains an extensive clinical pipeline with multiple label-expansion studies for elacestrant and tagraxofusp in breast and hematologic cancer indications, along with additional drug candidates in various development stages for solid and hematologic cancers.
The Menarini Group (search), with a $5 billion turnover and over 17,000 employees, operates 18 production sites and 9 Research and Development centers, making its products available in 140 countries worldwide. The company focuses on therapeutic areas with high unmet needs, including cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia.