Digital biomarkers are changing how we understand patient experiences and treatment impact, but turning that promise into real clinical and regulatory value takes more than just devices. It takes strategy, deep domain expertise, and a platform that delivers from one end of a clinical trial to the other.

At Medidata, those elements are coming together to drive new innovations in CNS clinical research. We spoke with Melissa Ceruolo, VP Engineering & Biomarker Analytics, to explore how Medidata is reshaping what’s possible with digital measures and remote data collection, which is building on years of foundational work.

From startup to scale: Medidata’s sensor story
Medidata’s digital biomarker journey began with MC10, a startup focused on analyzing motion and electrophysiology data using wearable sensors. “My team specialized in biomechanics, working with motion data across body locations, and with electrophysiology signals like ECG and EMG,” Ceruolo said. When Medidata acquired MC10 in 2020, that expertise became the backbone of Medidata’s sensor team.

Now, Medidata partners with leading medical device manufacturers to capture sensor data in both clinic and home environments, bringing interpretability and scientific insight to raw signals and anchoring them within a robust clinical data ecosystem.

A CNS-first approach to digital biomarkers
While the myMedidata ecosystem is built to be device-agnostic and flexible across indications, they are a scientific leader in the area of central nervous system (CNS) disorders.

“CNS is our sweet spot,” Ceruolo said. “We have the disease knowledge and the digital biomarker capabilities to make a real difference in how these trials are run.”

Medidata’s partnership with Cogstate exemplifies this strategy by pairing objective movement and electrophysiological data with cognitive assessments in a clinician-facing app. Their CNS-oriented platform incorporates algorithms for gait, postural sway, and activity complexity,  along with voice-based biomarkers for added insight, and it’s all integrated seamlessly into clinical workflows.

Rethinking the clinic visit
Sensor data collected in the clinic has significant potential to be used in conjunction with standard assessments to add precision and objectivity, which has high utility where bias and rater variability are present. 

“Traditional assessments like the Unified Parkinson’s Disease Rating Scale (UPDRS) are subjective by nature,” she said. “We’re adding a layer of objectivity by using sensors to analyze micro movements and measures that are difficult to quantify with the human eye.”

This additional layer provides critical quality control and context, enabling investigators to detect inconsistencies or subtle changes over time that conventional tools might miss. For diseases like Parkinson’s, Huntington’s, or multiple sclerosis, where progression is nonlinear and complex, that insight is crucial.

Remote monitoring with purpose
Ceruolo is quick to note the transformative potential of home-based data collection. Medidata’s patient-facing mobile app, myMedidata, and connected device ecosystem allow researchers to passively collect meaningful data in patients’ real-life settings.

“Our goal is to capture the same metrics we get in the clinic, like gait, sway, and other activity patterns, using just a single chest patch, as well as overall mobility behavior and sleep patterns,” she said.

In studies of Huntington’s and MS, the team found that just three days of passive data collection could yield highly representative mobility insights, making it possible to reduce patient burden while maintaining scientific rigor. Their standard recommendation: one week of continuous at-home monitoring, anchored by an in-clinic visit.

An integrated platform for actionable insights
Medidata’s greatest differentiator may be what happens behind the scenes. All sensor-derived data is co-located with labs, assessments, and other clinical trial data within myMedidata. myMedidata is the industry’s only comprehensive patient portal that offers an array of tools for patients’ trial activities, including eCOA, eConsent, sensors, LIVE video visits, and Registries, allowing sponsors to customize the level of remote engagement needed for their trials.  

“Sensor data isn’t just another data silo,” Ceruolo said. “It’s part of a holistic, interoperable ecosystem that supports decision-making from enrollment to endpoint.”

Leading the field through collaboration
Medidata is also helping define best practices through industry initiatives. Ceruolo and her team were active partners on the DATAcc by DiMe project to develop core digital measures for Alzheimer’s disease and related dementias (ADRD) and have used resources like Building the Business Case for Digital Endpoints to help build support and communicate the scientific and business value of digital biomarkers.

“These resources are critical for moving the field forward,” she said. “We use them with clients, in presentations, and as internal guidance.”

The future of digital biomarkers at medidata
As digital biomarkers mature, Ceruolo sees Medidata as uniquely positioned to lead with strategy and scientific insight.

“We’re not here to replace traditional assessments, we’re here to enhance them, to fill in the gaps, and to make clinical trials faster, smarter, and more patient-centric,” she said.

By combining deep CNS experience, validated digital measures, and an integrated platform, Medidata is delivering on that vision and ensuring that the future of clinical trials is both data-rich and deeply human. 

Learn more about Medidata’s ability to complement subjective ePRO data with high-fidelity objective sensor data, which promises groundbreaking insights into CNS research and improved patient outcomes by reading our blog here https://mdso.io/cq2.

Get Involved with DiMe
Medidata’s work is informed and amplified through DiMe initiatives like DATAcc. DATAcc projects focus on advancing digital health measurements by developing new evidentiary frameworks and measures in a pre-competitive environment. Join a broader group of leaders across the healthcare ecosystem to establish and execute a shared vision of high-quality digital health measurement that is easily accessible and beneficial for everyone. Learn about joining an upcoming project here.