Are You Ready to Digitally Enable Your Trial? Key Considerations for Decentralizing and Decreasing Patient Burden

Life science companies are working around the clock to develop therapies, treatments and tests to address the COVID-19 pandemic head-on. In support, regulatory bodies around the world have recognized the immediate threat to clinical research and encouraged the decentralization and digitization of trials. For the industry, pivoting to a digital-based approach can help reduce patients’ exposure during a pandemic and provide business continuity for sponsors. By adapting and updating protocols, research becomes more convenient for patients and their loved ones.

Now, more than ever, it’s critical to have a strategy to implement remote engagement at scale to maintain and advance lifesaving clinical research. In this complimentary webinar, experts will provide the essential building blocks needed to ensure that programs continue forward in an era where digital avenues will be paramount.

Components of a well-structured decentralized trial include:

• Electronic clinical outcome assessments (eCOA)
• TeleVisits
• eConsent
• Providing and utilizing devices to capture key endpoints and measurements
• Digitally inclusive study designs and protocols

Integrating these elements can provide patients the opportunity to participate in clinical research during the COVID-19 pandemic from the comfort and safety of their own home.

Each day, the industry’s traditional view of clinical trials is being challenged as biotechnology and pharmaceutical companies transition to flexible, digitally enabled study models. Sponsors are making transformations today and future-proofing against risk and complexities in parallel. Embracing a digital mentality and infrastructure is both inevitable and imperative – this is how trials have and will continue to evolve.

Speakers

Niklas Morton, Senior Vice President, Digital Services, PPD

Niklas Morton serves as senior vice president of PPD’s digital services. In this role, he oversees the operations and delivery of digitally enabled and decentralized/virtual studies, along with PPD‘s robotic automation capabilities.

Prior to his most recent appointment, Morton was senior vice president of site and patient access, overseeing the site intelligence and activation, strategic feasibility, strategic site collaboration and clinical innovation teams. In that role, he led more than 1,400 professionals engaged in the identification and activation of the right research sites for each trial to access the most patients in the shortest cycle times.

Since joining PPD in 1998 as a biostatistics manager, Morton has advanced through various roles of increasing leadership and responsibility within the company. He spent nearly five years in PPD’s project management department, where he had section-head responsibility for PPD’s Europe, Middle East and Africa (EMEA) hematology/oncology group.

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Brittany Erana, MPM, Vice President, PPD Digital, PPD

Brittany Erana is vice president and head of operations for PPD’s digital services. In this role, she is responsible for setting the vision and designing the operational infrastructure and capabilities necessary to successfully deliver decentralized and digitally enabled clinical trials while upholding quality.

Erana brings more than 15 years of broad industry experience in global research operations and strategy, digital implementation project and program delivery. Prior to joining PPD, Erana was the global head of operations for patient-centered science and technology at another CRO where she spent nine years building out new operational capabilities and driving organizational growth across Europe and Asia-Pac.

Erana holds a Bachelor of Arts in psychology from East Carolina University, a master’s degree in project management from Western Carolina University and a certificate in international business from University College Dublin Smurfit Business School.

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