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 35,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world.
Given Medidata's extensive presence and influence in the industry, what role do you see the company playing in the transformation of clinical trials?
Medidata plays a foundational and transformative role in biopharma. We are deeply embedded in clinical drug development, directly impacting patient outcomes and improving the way therapies are brought to market. At any one time, our technology is supporting thousands of ongoing clinical trials worldwide, and we’re proud to say that we help bring life changing new therapies to patients each year.
We have carved out a unique position by focusing on data interoperability and patient engagement, which are areas that have often been overlooked in clinical trials. By connecting patients, hospitals, biopharma companies, and trial sites, we improve the flow of data in clinical trials and make the experience better for patients.
What would you say has set Medidata apart from its competitors, particularly in a field that often resists rapid technological change?
What sets Medidata apart is how deeply we are integrated into clinical trials worldwide. This is an industry that is naturally cautious, and understandably so, given the massive financial risk and regulatory complexity involved. Moving a drug through the full development process can cost billions of dollars, and with so much on the line, there is a real "wait and see culture" when it comes to adopting new technologies.
That said, the inefficiencies in the traditional model cannot be ignored. We have stepped in to meet this need with solutions that focus on patients and improve trial efficiency, all while maintaining the high standards this industry demands. That balance of being both innovative and reliable is what truly sets us apart.
What do you believe will be the inflection point for AI adoption in clinical trials, and how is Medidata preparing for it?
The inflection point for AI in clinical trials is coming. The COVID-19 pandemic showed us how quickly the industry can move when needed, with regulatory and clinical hurdles cleared in record time. Many of us thought that experience would permanently change how we operate, but as the urgency faded, old habits crept back in.
Now, AI is giving us another chance to transform the way we work. So far, we’re seeing our customers take the lower-hanging fruit, like email, contract reviews and so on, but we believe more impactful use cases are right around the corner—and we’ve been innovating for this for a few years now. At Medidata, we are using AI to address the most repetitive challenges, like automated study builds, and also the most difficult challenges, like creating synthetic control arms. These AI-driven control groups built from historical data, allow us to simulate control populations without needing to recruit patients to a study just to give them a placebo dose. Everything we’re doing to advance our AI program points back to either solving an industry ethical dilemma or creating an efficiency gain that helps our customers deliver new therapies to patients faster.
Is Medidata working toward a future where AI might replace some aspects of human participation in trials?
At Medidata, we are working toward a future where virtual twins of patients can fundamentally transform clinical trials. Our parent company, Dassault Systèmes, has long been innovating virtual twin models in several industries to accelerate the speed and predictability of R&D efforts. We see the health sciences and research industries as the next frontier for this important innovation. Today, we’re already able to gain benefits from tools like AI-driven patient “Simulants” and virtual twin models of specific organs like the heart and brain. These models, built from diverse patient data, can help clinicians and researchers design and simulate the outcomes of research programs, and are really paving the way for trials that rely less on direct human participation.
Reaching this future will take time, given the regulatory and logistical challenges, but progress is underway. AI is already helping us design trials that are more precise, predictive, and inclusive, reducing the risks and inefficiencies of traditional studies.
What trends do you anticipate will reshape the clinical research landscape in the U.S. over the next few years?
The future of clinical research is being shaped by advancements in trial design and simulations, allowing us to more strategically engage patients at the most critical parts of the process, and to better partner with them for data sharing and evidence generation. Digital therapeutics are a particularly exciting new way we’re looking to support patients even beyond the clinical trial. These software-based interventions enhance treatment outcomes when used alongside traditional drugs, and can be prescribed after providing clinical trials evidence that they demonstrate additional efficacy. This combination is quickly creating a new standard of care where technology and medication work together to deliver greater clinical impact than either could alone.
The industry is moving beyond isolated drug trials toward an integrated, technology-driven healthcare model. Medidata is leading this shift through investments in digital therapeutics and AI-driven simulations, paving the way for trials that are faster, safer, and more inclusive. Ultimately, these innovations will improve patient outcomes and deliver more robust therapeutic solutions to the world’s most complex healthcare challenges.
