Data Partners

Powering DCT with Next-Gen eClinical Data Accelerates Clinical Trial Transformation

Executive Director Digital Trials Strategy at Oracle.

MaryAnne Rizk is a Chief Strategy Officer at Medable.

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Data Partners: Powering DCT with Next-Gen eClinical Data Accelerates Clinical Trial Transformation

By David Blackman, Oracle’s Executive Director Digital Trials Strategy, Health Sciences Global Business Unit and MaryAnne Rizk, Ph.D, Medable’s Chief Strategy Officer.

When it comes to clinical trials, cost, speed, convenience, and efficiency are the priorities for sponsors, partners, and patients. Heeding that call, drug developers have pivoted to decentralized clinical trials (DCTs) to reduce site burden and study costs while improving trial pace and overall patient experience. Decentralized clinical trials (DCTs) at their core allow researchers to increase the number of participants, reduce their burden of participation, and collect better data.

While with the right tools, it’s possible to screen 10,000 patients per day, enable 30,000 per month to schedule appointments, and provide remote or in-person visits to 180+ sites worldwide. With eConsent, eRecruitment, and direct-to-patient shipments, a decentralized workflow enables greater patient access while providing a flexible and seamless experience across all users that improves trial operations and time to treatment.

But operationalizing this revolution in clinical trials requires technology that can keep pace and help drive patient-centered innovation even further, and our industry has struggled to efficiently operationalize and integrate DCTs into traditional methods of running clinical trials.

To improve patient access, enrollment, retention and bring critical drugs to market sooner, a connected ecosystem of partners that includes the right technology, scientific and operational expertise must collaborate to solve interoperability between systems, processes and people. Siloed operations and data collection must become a thing of the past.

DCT and eClinical Platforms Join Forces to Create Powerful Solutions

Research shows that 35% of patients who drop out of clinical studies do so due to a lack of understanding of their participation in a trial right at the beginning. 

As part of the Medable Partner Network (MPN), Oracle, one of the world’s leading software companies, brings the site-centricity of its expert Clinical One R&D platform to the patient-centricity of Medable’s DCT SaaS platform. Oracle’s Clinical One Data Collection, a cloud-based platform that provides data flow, analytics, and reporting capabilities across clinical technology applications, collects data from numerous sources— Site collected clinical data, eConsent forms, wearable sensors, patient apps, electronic health records (EHR), labs—and then harmonizes it as a “single source of truth” for all stakeholders across the clinical research team. This unified platform significantly reduces site burden by enabling randomization, drug dispensation, and patient data collection through a singular data stream in one system.

Moreover, patient-derived data is provided instantaneously through Oracle’s eClinical suite, enabling real-time integration, interrogation and actionable data insights for study sites so they can expedite any necessary patient support. For example, Clinical One eases both the patient and site burden by standardizing electronic informed consent and improving patient understanding of trials through visual and auditory technology. Both features can improve patient compliance and reduce protocol deviations, resulting in significant time savings for sites.   

What does this mean for sponsors, partners, and patients? For the first time, the ease-of-use and security of Medable’s patient app can be integrated seamlessly with the databases maintained by sites and sponsors—bringing together clinical operations data across the eClinical suite with patients’ clinical data.

Deep Integration Improves Data Flow—and Saves Time

Medable’s patient-centric DCT platform, data collection capabilities, and integrated ecosystem of 35,000-plus trial sites worldwide creates a fully integrated solution for sponsors. Medable’s DCT expertise reduces trial time and costs while increasing participant access and diversity. And the partnership between Oracle’s Clinical One and Medable improves trial speed, efficiency, and scalability.

Large pharmaceutical, biotech clients, and CROs have sought out Medable and Oracle’s collective solution to power their DCT enabled studies. 

The partners have already put their solution to work, implementing a blended platform that eliminates the need for manual data integrations and creates significant study-startup, building efficiencies.  The collective solution also creates meaningful improvements in patient care by substantially reducing patient visits, travel time, and complexity of data gathering and reporting.

Surveys indicate that up to 75 percent of clinical trial participants prefer using mobile data technology, while 80 percent of patients would be more likely to join a trial if mobile technology were an option. Providing a seamless patient experience is a key component of trial success that benefits everyone.

Together, Oracle and Medable are creating real value for all stakeholders in drug development:

  • Patients: Simplified trial participation experience for remote & hybrid trials, leveraging  real-time data collected from eCOA, Televisit, and  eConsent
  • Sites: Consolidated source of truth, real-time access, single data entry
  • Sponsors: Improved compliance and data quality with simplified workflow and unprecedented visibility into studies

MPN is advancing the paradigm shift in drug development by empowering a diverse network to collaborate, innovate, certify, and launch efficient decentralized clinical trials. This enables partners to make better decisions through access to hundreds of data types from extensive external sources across interactive response technology (IRT), EDC, clinical trial management systems (CTMS), electronic medical records (EMR), labs, sensors, custom systems, and more.

As the most diverse and most trusted ecosystem of DCT—with over 40 partners including CROs, System Integrators, Sites, Data & Tech—Medable provides access to the smartest path forward for your organization and studies as they scale.  

Quality, speed, cost, and efficiency are the holy grail of successful drug development. Merging Medable’s best-in-class patient experience with solutions from industry leaders like Oracle means the urgent race to develop better medicines is about to take a quantum lead forward. We are #FasterTogether.