In an interview with PharmaShots, Anthony Costello, President, Patient Cloud at Medidata share his views on the launch of Sensor Cloud which is a transformative platform for managing a sensor and digital health technology data during the clinical trials.

Shots:

• The company launches Sensor Cloud for managing sensor and digital health technology data during the clinical trial. Sensor Cloud integrates with Medidata Rave Clinical Cloud and supports continuous patient data collection from both Medidata and third-party medical-grade sensors
• The launch of Sensor Cloud strengthens Medidata's unique data ingestion, analytics & insights capabilities, providing differentiated value to patients, trial sites, trial sponsors and CROs
• Medidata will continue to expand its growing list of supported devices and sensors that includes BioStamp, ActiGraph, and BioIntellisense in 2021

Tuba: Discuss the specifications of Sensor Cloud. What will be the benefits of using Sensor Cloud?

Anthony: Sensor Cloud is the only global, scalable, unified platform solution that simplifies and expedites sensor integration, data ingestion and analysis, and digital biomarker discovery. It enables greater insights through proprietary analytics that support novel digital biomarker discovery. Our technology provides the capability to connect to any sensor/device in a matter of weeks and ingest and normalize data from any source. We also provide the expertise required through our own Professional Services organization and/or CRO partnerships that are established to deliver this full array of solutions with Sensor Cloud.

Tuba: How is Sensor Cloud impactful in the COVID-19 pandemic?

Anthony: During the COVID-19 pandemic, many clinical trials were paused in part due to the patient's inability to travel to the trial site for scheduled clinical visits, making it that much more difficult to communicate between clinical trial patients and study staff. Clinical trial virtualization technologies pioneered by Medidata and the launch of Sensor Cloud have allowed clinical research to continue during this time by cutting down on-site visits, time, and travel through a more flexible engagement model.

Tuba: Sensor usage in clinical trials is projected to surge up to 70% by 2025. Can you shed light on the statement?

Anthony: Sensors can help track a wide variety of key metrics including respiratory rate, sleeping patterns, blood pressure, heart rate, and other critical health functions that historically have been monitored during traditional onsite visits and check-ins. As traditional trial processes are reimagined to create a more flexible patient experience, technology advancements are propelling the research industry toward adoption of virtualization technologies at breakneck speeds. These advancements will continue to grow in popularity, outlasting the pandemic and, as trials continue to improve and become more patient-centric, communication and engagement become increasingly important. (The statistic comes from: https://www.intel.ca/content/dam/www/public/us/en/documents/solution-briefs/transforming-clinical-trials-with-the-power-of-ai-brief.pdf)

Tuba: How will the launch of Sensor Cloud improve clinical outcomes?

Anthony: Sensor Cloud enables a flexible patient data capture approach that can reduce the patient burden associated with frequent site visits, while shifting qualitative data capture methods (such as patient questionnaires) to much more fluid and quantitative objective data from medical grade devices. Bringing device data together with electronic outcomes data (eCOA), safety data, dosing schedules, and labs can begin to form a much more holistic view of what is truly happening for a patient in a real-life clinical research setting.

Further, because wearables and other digital health technologies provide the data insight necessary for the development and delivery of precision therapies, they're an essential component in the life science industry's transition to a patient-centric operating model. Virtual trials technologies like these will continue to transform life sciences while also addressing the patient burden concerns that have long plagued the clinical trials industry.

Tuba: What does the launch of Sensor Cloud mean for the company?

Anthony: As a patient-centered organization, Medidata has been trailblazing the virtualization of clinical trials with Patient Cloud offerings like myMedidata and remote data capture tools including eConsent, eCOA, and Telehealth and Virtual Visits. Now, by tightly integrating Sensor Cloud, we can further support our clients exploration of this innovative research model and enhance our industry-leading portfolio of technologies that streamline the trial experience for customers, sponsors, and our CRO partners.

Tuba: Discuss your acquisition of the Digital Biomarker Business of MC10. And how does it help in enhancing remote biometric data capture capabilities in hybrid and virtual clinical trials?

Anthony: MC10's offerings brought novel clinical analytics and biosensor capabilities to Medidata's existing Patient Cloud solutions in ePRO (patient-reported outcomes), eCOA (clinical outcome assessments), and biomarker discovery. This enhanced Medidata's capabilities of integrating data from wearable sensors including clinical grade metrics to help customers successfully virtualize clinical trials.

Remote, patient-centered technologies have become an essential part of clinical research, especially in the age of COVID-19; the physical restrictions placed on patients and clinical sites caused by the pandemic can interfere with launching a clinical study and carrying it to completion.

Medidata leads the industry in building and integrating new technologies to revolutionize clinical research in pursuit of patient-centric therapy development. MC10's focus on clinical-grade data capture and novel digital biomarker development represents an important next chapter advancing the understanding of disease progression and treatment effect in the home.

Tuba: What are your plans to enhance the clinical trial experience for patients?

Anthony: At Medidata, we are committed to celebrating the role that clinical trial participants bring to making new medicines and vaccines possible.  We understand that without the individuals who raise their hands and say, I want to be part of the solution, there would be no solution.

The patient journey extends before and after a clinical trial, starting with education about clinical research and disease states, to clinical trial matching and investigator selection, moving through the informed consent process, study visits, sensors and wearables, data collection, and patient data return.  Incorporating patient preferences in interactions, accessibility, site convenience, support, and engagement can lead to improved patient experiences and greater satisfaction. 

The life science industry frequently uses patient centricity as a buzzword but promoting the idea of patient centricity without action dilutes the term's meaning and frustrates patients. To go beyond the buzzword, Medidata established patient centricity by design (PCbD), the formal process of infusing the patient perspective into the software development life cycle to create technical solutions that improve the overall patient experience in clinical research interactions.  Each Medidata product is reviewed and approved by Patient Advocates as part of our Patient Design Studios.  Our patient advocates are paid consultants who leverage their expertise in evaluation for key points of patient inclusion, resulting in superior products and improved patient experiences.

Tuba: Please discuss Medidata's growth and its products so far.

Anthony: Medidata is a technology company that develops cloud-based solutions for clinical trials. These include everything from protocol development to post-data lock disease registries and commercial tools. The Medidata platform of capabilities allows sponsors, clinical research organizations (CROs), sites, and patients a way to work collaboratively in a clinical research setting by sharing access to critical data capture and surveillance tools such as eConsent, clinical site collaboration and management; randomization and trial supply management; patient data capture through web forms and sensors, mobile health applications like electronic patient-reported outcomes (ePRO), laboratory reports, and imaging systems; quality management; safety event capture, and monitoring and business/clinical analytics.

Under the leadership of co-founders Glen de Vries and Tarek Sherif, Medidata has transformed clinical development through technology. The two have guided Medidata through its rapid growth to establish one of the largest software companies in New York City and one of the industry leaders in electronic data collection and management solutions. Today, Medidata is the platform of choice for more than 1,700 customers, including most of the top pharmaceutical and biotechnology companies, and contract research organizations (CROs).

Medidata's focus on research and development and deep industry knowledge continue to drive new, game-changing initiatives and strategic partnerships. Medidata Acorn AI leverages the company's rich, regulatory grade clinical data, machine learning and artificial intelligence capabilities, and pharmaceutical product development expertise to drive value for life sciences companies. Medidata Acorn AI is dedicated to making data liquid across the end-to-end life cycle of a pharmaceutical and life sciences company - from research all the way to development and into post-market. This is made possible by leveraging an unsurpassed cross-industry data set, which spans 23,000+ trials and more than 7 million unique patients.

Main Image Source:  MediData

About Anthony Costello

Anthony Costello is President, Patient Cloud at Medidata, a Dassault Systèmes company, which powers smarter treatments and healthier people.

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