Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, has won four awards in the 2025 Clinical Trials Arena Excellence Awards for its outstanding contributions to the advancement of clinical trials through digital transformation.
The Clinical Trials Arena Excellence Awards honor the most significant achievements and innovations in the clinical trials industry. Powered by GlobalData’s business intelligence, the Awards recognize the people and companies leading positive change and shaping the industry’s future.
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Medidata won two Innovation awards in the Clinical Data Integration and CNS Trial Optimization categories for introducing transformative solutions that streamline clinical data integration and optimize CNS trial execution. Medidata’s strategic expansion into digital therapeutics earned it the Business Expansion award, reflecting its commitment to next-generation patient-centric care. Additionally, it won the Product Launches award for its pioneering approach to protocol design, leveraging artificial intelligence (AI) to enhance trial efficiency and outcomes.
Advancing clinical data integration with AI-driven Clinical Data Studio
Medidata Clinical Data Studio, an integral part of the Medidata Data Experience, has been recognized for its ability to address one of the most persistent challenges in clinical research: the fragmentation of clinical data across multiple systems and vendors. Traditionally, clinical trial teams have struggled with siloed data sources, manual reconciliation processes, and lengthy review cycles, all of which can delay decision-making and increase operational risk.
Clinical Data Studio addresses these issues by providing a unified, AI-powered data quality management platform that aggregates, standardizes, and enables real-time review of data from both Medidata and non-Medidata sources. Its no/low-code environment allows IT and clinical programming teams to configure the platform in as little as three days, significantly reducing the technical and resource barriers that have historically slowed implementation.
The platform’s impact is evident in real-world deployments. For instance, Everest Clinical Research adopted the solution to accelerate data collection and improve data visualization, enabling more actionable insights for sponsors.
Quantitative results from these deployments include up to 80% faster data review cycles, a 50% reduction in patient profile review times, and 90% faster listing builds. The platform’s advanced analytics and machine learning capabilities support proactive risk management, enabling earlier detection of data anomalies and site performance issues. By fostering cross-functional collaboration and providing a real-time, unified data experience, Clinical Data Studio accelerates clinical discovery, enhances patient safety, and supports faster delivery of new therapies to market. The widespread adoption by top-tier CROs and pharmaceutical companies underscores its significant industry impact.
Optimizing CNS trials: The Medidata and Cogstate partnership
Central nervous system (CNS) clinical trials are among the most complex and demanding in the industry. They are often characterized by intricate assessments, high variability, and significant operational burdens for both sites and participants. These trials require precise measurement of cognitive and neurological outcomes, which can be compromised by inconsistencies in rater performance, fragmented technologies, and the subjective nature of traditional clinical measures.
Medidata’s strategic partnership with Cogstate was recognized for addressing these challenges through a deeply integrated, end-to-end electronic clinical outcome assessment (eCOA) solution tailored to CNS studies. By combining Medidata eCOA, an integral part of the Patient Experience, with Cogstate’s neuroscience expertise, the partnership delivers a unified workflow and operational infrastructure that streamlines the rater training, scale administration, and data quality oversight of cognitive assessments across global CNS programs.
Key features of the solution include automated access to study scales based on rater certification, ensuring that only qualified raters can conduct specific assessments. This reduces the risk of variability and error, while scientifically enhanced eCOA capabilities simplify the workflow and scale administration for sites and raters. The unified implementation and monitoring workflows enhance operational efficiency, allowing for real-time oversight and timely feedback.
The effectiveness of this approach has been validated in several CNS trials. For example, the automation of qualification-based rater access to eCOA forms and the integration of Cogstate’s central monitoring platform have accelerated site feedback and improved study monitoring efficiency. The partnership also supports remote assessment administration via telehealth, reducing site and patient burden while maintaining data integrity.
Beyond operational improvements, the Medidata-Cogstate partnership advances the field through ongoing innovation. Integrating AI-powered monitoring, predictive analytics, and digital biomarkers enables earlier detection of disease progression and further optimizes endpoint data quality. These advancements improve trial outcomes’ reliability and enhance the experience for patients, caregivers, and raters, who often face significant challenges in CNS trials. By setting a new operational model for CNS trial execution and demonstrating measurable improvements in data quality and efficiency, the partnership has established itself as a benchmark for innovation in this complex therapeutic area.
Expanding into digital therapeutics: Medidata’s investment in Click Therapeutics
Medidata’s strategic investment in Click Therapeutics marks a significant expansion beyond traditional clinical trials into the rapidly evolving field of digital therapeutics (DTx) and software-enhanced (SE) drugs. This move reflects Medidata’s recognition of the growing importance of digital health solutions in delivering patient-centric care and supporting the full continuum from clinical research to real-world outcomes.
Click Therapeutics specializes in developing prescription digital therapeutics—evidence-based software interventions that are regulated as medical devices and designed to prevent, manage, or treat medical conditions. By partnering with Click Therapeutics, Medidata can leverage its Medidata Platform, myMedidata, and AI-powered data management capabilities to accelerate these novel therapies’ development, validation, and regulatory approval.
The partnership enables a unified offering that supports pharmaceutical partners in expanding treatment options by combining traditional drugs with digital interventions. For example, software-enhanced drugs co-package a branded medication with a digital therapeutic tailored to the specific needs of the patient population, delivering added clinical benefit compared to medication alone. This approach aligns with recent FDA draft guidance on Prescription Drug Use-Related Software (PDURS), positioning Medidata and Click Therapeutics to lead the next generation of combination treatments.
The investment in Click Therapeutics also reinforces Medidata’s commitment to improving patient engagement and outcomes during clinical trials and throughout the entire healthcare journey. By supporting the development of regulated, software-based treatments, Medidata is advancing the Patient Experience and helping to expand the boundaries of medicine and address unmet needs in areas where pharmacotherapy alone may not be sufficient.
Enhancing protocol design with AI-based protocol optimization
Protocol design is a foundational element of clinical trial success, and a poorly designed trial can lead to operational complexity, costly amendments, and enrollment delays. Inefficient or overly complex protocols can increase patient and site burden, slow recruitment, and ultimately delay the delivery of new therapies to patients.
Medidata Protocol Optimization, launched as part of its unified Study Experience, addresses these challenges by leveraging AI-driven predictive modeling and industry-wide standardized clinical trial data. The solution enables clinical operations teams to simulate the impact of protocol design decisions before trial initiation, quantifying potential effects on patient burden, site performance, and drop-out rates. This foresight allows teams to proactively identify and mitigate risks, reducing the likelihood of protocol amendments and streamlining trial execution.
The solution’s integration with the Medidata Platform ensures that protocol optimization is part of an end-to-end approach to trial design, planning, and execution.
“These awards are a testament to the Medidata team’s relentless commitment to transforming clinical research through digital innovation. By harnessing the power of AI, data integration, and patient-centric technologies, we are accelerating the pace of clinical discovery and raising the standard for trials and patient care across the industry. Our partnerships and investments reflect our vision for a future where every clinical trial is smarter, faster, and more successful. Central to this vision is our dedicated focus on the Patient, Data, and Study Experiences, which unifies and elevates every touchpoint for patients, sites, and sponsors, making clinical trials more intuitive, collaborative, and impactful. We are honored to be recognized by the Clinical Trials Arena Excellence Awards and remain dedicated to shaping the next era of clinical development.”
– Lisa Moneymaker, chief strategy officer, Medidata
Company Profile
Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 36,000 trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million registered users across approximately 2,300 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com. Listen to our latest podcast, from Dreamers to Disruptors, and follow us at @Medidata.
Dassault Systèmes is a catalyst for human progress. Since 1981, the company has pioneered virtual worlds to improve real life for consumers, patients and citizens. With Dassault Systèmes’ 3DEXPERIENCE platform, 370,000 customers of all sizes, in all industries, can collaborate, imagine and create sustainable innovations that drive meaningful impact. For more information, visit: www.3ds.com.
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