Medidata, a Dassault Systèmes company, has launched its Sensor Cloud platform, designed to help trial teams optimize management of wearable sensors and collection of related data during clinical trials. The technology integrates with the company’s Rave Clinical Cloud data management platform, and it is engineered to support continuous patient data collection from Medidata and third-party sensors.
Anthony Costello (AC), president of Patient Cloud at Medidata, recently spoke with Outsourcing-Pharma (OSP) about the Sensor Cloud Platform and how such technology is helping advance decentralized trials.
OSP: Could you share an overview of the evolution of wearables in clinical research?
AC: We are in the second wave of wearables, or what we like to reference as digital health technologies in clinical research, since we are not limited to just the data being collected from what is worn, but also from non-wearable sensors/devices, invisibles and ingestibles.
The first phase marked a range of experimentation where Sponsors and CROs used wearables, often consumer grade devices, to capture data from patients; this phase focused on “getting the data” and managing operational risk of using new data capture techniques. Our launch of Sensor Cloud coincides with what we see as the second phase - a migration to higher quality medical grade data streams and an increased frequency of sensor usage in clinical research, both at the individual study and enterprise level.
Sensor Cloud is the only global, scalable solution for ingesting and organizing this data for Sponsors. It also sets us up for what we see as phase three of digital health technologies in clinical research - an increasing emphasis on biomarker discovery based on sensor usage, particularly when it is combined with other data in a patient’s journey in a clinical trial.
OSP: How do sites and sponsors manage the streams of data coming in from wearables? What have been some of the biggest challenges in collecting and managing data from wearable sensors used to collect patient data?
AC: Today, it is challenging; disparate device capabilities result in technical, logistical and analytical barriers for sponsors and CROs. Getting a new device up and running in a study can take months today; once data is produced by a patient, getting that data into one safe, secure, organized format available for analysis is a significant and often evolving technical challenge due to the wide variety of data transfer approaches from today’s devices. Analyzing data with often different labeling schemes hampers the insights available from this valuable data.
OSP: Could you please share some of the most notable aspects of Medidata’s technology that helps combat these challenges, and especially how the Sensor Cloud platform helps manage the data in a way that stands out in the field?
AC: Sensor Cloud solves all of these key pain points by rapidly integrating a growing library of high-quality device platforms appropriate for clinical research.
Curated, growing sensor/device library integrated into Sensor Cloud
Medidata is partnering with leading sensor/device vendors to integrate their data streams into Sensor Cloud, reducing the time for deployment in a study from months to weeks, thereby lowering operational risk for deployment devices in clinical research. Ultimately high-quality vendors will be able to join the Sensor Cloud ecosystem through an accreditation program ensuring Sensor Cloud always has the latest and best market offerings available.
Data transfer and storage is simplified at a secure, global scale
Medidata is making investments to make seamless, secure global transfer of data from devices integrated into Sensor Cloud.
The Common Model
Perhaps most important for the future value of this device data is Medidata’s approach to the Common Model, an approach to organizing ingested sensor data to accelerate development of analytical insight and biomarker discovery. The Common Model solves one of the most significant challenges with collecting sensor data - making it ready and available for insight generation in the context of disease progression and treatment effect by standardizing the myriad of labeling approaches to high-quality sensor data.
Sensor Cloud data becomes more valuable when combined with other important clinical data housed in Medidata’s Rave platform. This is a unique advantage of Sensor Cloud - accelerated biomarker development leveraging the breadth of Medidata’s data assets including Rave and other complementary products like eCOA (electronic Clinical Outcome Assessment).
OSP: Is there anything you’d like to add about the Sensor Cloud technology, Rave Clinical Cloud, or other Medidata offers around decentralized trials?
AC: Collecting high-fidelity sensor data continues a trend in virtualization in clinical trials. Medidata has been at the forefront of this trend with its Patient Cloud offerings including myMedidata. Moving the patient to the center of all we do in clinical research is a key focus for the organization, a tight integration of Sensor Cloud with other tools to reduce patient burden by remote data capture, including eConsent, eCOA and telehealth visits, represent an industry-leading portfolio of technologies that streamline the experience for patients, sponsors and our CRO partners.