Companies Launch New Framework to Accelerate COVID-19 Research; Streamlines Path for Diagnostics, Monitoring and Clinical Trials

PALO ALTO, Calif.–(BUSINESS WIRE)–#clinicaltrials—Medable Inc. today announced a multi-company research framework to accelerate development of diagnostics and treatments for COVID-19, providing individuals fast access to participate in leading-edge research for diagnostics, health monitoring and interventional clinical trials. The ACCESS initiative—short for American COVID-19 Collaborative Enabling Seamless Science—provides a mobile consumer application and secure infrastructure to quickly connect health researchers and clinical trial teams securely with up to millions of home-bound individuals in the United States.

ACCESS makes it easy for individuals to contribute specific information about their COVID-19 experience, combine it with health records and data from wearable devices, and opt in to participate in current and future studies for diagnostics, treatments and vaccines. The data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale.

ACCESS is a collaborative effort led by Medable, together with technology, healthcare and life sciences companies including BioIntelliSense, Datavant, Parexel, PWNHealth and the American Heart Association’s Center for Health Technology and Innovation. ACCESS takes full advantage of mobile and digital health technologies to facilitate at-home research, clinical trial access, and population-based long-term outcome studies. The infrastructure combines medical-grade wearable sensors, patient-reported data and outcomes, historical health data and health record aggregation. Participants opt in at every stage, so they maintain control over their personal health data—and decide how they want to engage in potential studies.

“ACCESS will enable us all to accelerate diagnostic testing and clinical trials—and advance important monitoring and immunity research—so that we can conquer COVID-19 with effective prevention and intervention strategies,” said Dr. Michelle Longmire, CEO and co-founder of Medable, which built the mobile application and digital infrastructure for ACCESS. “By empowering people in their homes with ACCESS, we can accelerate research by reducing time for enrollment and data collection.”

ACCESS provides screening, disease and immunity status testing, and general lab testing to qualified participants through PWNHealth’s national network. “This is a pivotal point in the pandemic and PWNHealth can play an essential role in the ACCESS program, leveraging our national clinician network, telehealth capabilities, and laboratory partnerships to enable patient access to testing at scale,” said Sanjay Pingle, CEO, PWNHealth.

ACCESS enables vital sign data collection via smart watches including the Apple Watch, as well as continuous health monitoring through FDA-cleared body-worn sensors from BioIntelliSense. “We are honored to combine forces with leading industry organizations and apply our advanced biosensor technology and medical-grade data services to research COVID-19,” said James Mault, MD, CEO of BioIntelliSense. “The FDA-cleared BioSticker device can play a key role in infectious disease monitoring by enabling effortless and continuous data capture of multi-parameter vital signs.”

ACCESS enables participants to provide researchers access to de-identified health records, claims, diagnostic and other data sources via Datavant’s data infrastructure. “Accelerating the pace of clinical development will help patients get access to life-saving therapies more quickly,” said Travis May, Datavant CEO. “We’re excited to help power ACCESS and accelerate clinical trials by making it easier to connect to the ecosystem of real-world data.”

ACCESS removes key bottlenecks in research, making it easier for clinical trial leaders to recruit and monitor patients, while shortening timelines for diagnostics, treatments, and vaccines. “We have seen a rapid response from the pharmaceutical industry to the COVID-19 crisis, with hundreds of clinical trials underway in a remarkably short period of time,” said Jason Martin, Senior Vice President, Global Data Operations, Parexel. “The next challenge is connecting patients to these studies, which is particularly difficult in this fast-changing situation. Fortunately, today we have access to more data as well as innovative ways to de-identify and link that data to help connect the right patients to the right studies. We look forward to working with the ACCESS study team to harness that connectivity to bring hope to patients in need.”

The American Heart Association played a valuable role in helping Medable bring together various parties to contribute to ACCESS. “Connecting innovative companies in health tech is a big part of what we do at the Center,” said Patrick Wayte, SVP, American Heart Association Center for Health Technology and Innovation. “Convening parties to develop novel ways of improving clinical care and research, with the ultimate aim of improving patient outcomes, is a core philosophy of the Association. We see that digital healthcare solutions can play a huge role in the transformation of medicine, and we’re glad to help catalyze these changes.”

For more information on ACCESS, go to https://access.medable.com/

About The Companies

American Heart Association: The American Heart Association is a leading force for a world of longer, healthier lives. With nearly a century of lifesaving work, the Dallas-based association is dedicated to ensuring equitable health for all. We are a trustworthy source empowering people to improve their heart health, brain health and well-being. We collaborate with numerous organizations and millions of volunteers to fund innovative research, advocate for stronger public health policies, and share lifesaving resources and information. Connect with us on heart.org, Facebook, Twitter or by calling 1-800-AHA-USA1.

BioIntelliSense: BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM). Its medical-grade Data-as-a-Service (DaaS) platform seamlessly captures minute-to-minute vital signs, physiological biometrics and symptomatic events through an effortless patient experience. The FDA-cleared BioSticker™ device makes remote monitoring and early detection simple. Through the platform’s advanced analytics, clinicians will now have access to high-resolution patient trending and reporting to enable medical grade care in the home. For more information, please contact us at info@biointellisense.com or visit our website at BioIntelliSense.com.

Datavant: Datavant’s mission is to connect the world’s health data to improve patient outcomes. Datavant works to reduce the friction of data sharing across the healthcare industry by building technology that protects the privacy of patients while supporting the linkage of de-identified patient records across datasets. Datavant is headquartered in San Francisco. Learn more about Datavant at www.datavant.com.

Medable: Medable is on a mission to reduce clinical trial timelines by 50 percent. The company’s decentralized digital platform streamlines design, recruitment, retention and data quality for decentralized trials, replacing siloed systems with integrated digital tools, data and interfaces to accelerate trial execution. Medable connects patients, sites and clinical trial teams to improve patient access, experience, and outcomes. Medable is a privately held, venture-backed company headquartered in Palo Alto, California. For more information, visit www.medable.com and follow @Medableinc on Twitter.

Parexel: Parexel is focused on supporting the development of innovative new therapies to improve patient health. During the COVID-19 crisis, we continue to be committed to our clients’ business while putting the safety of patients, client partners and our employees at the heart of everything we do. To learn more about our efforts related to COVID-19, as well as the experts, innovations and processes we have in place to navigate the new and rapidly changing landscape, visit our website and follow us on LinkedIn, Twitter and Instagram.

PWNHealth: PWNHealth is a national clinician network working to improve early detection and prevention of disease using advanced diagnostics and telehealth. PWN services all 50 states with telehealth and telegenetic services. Our model enables safe and easy access to diagnostic testing, ensuring clinical validity, utility, quality consumer education, access to clinicians, and the ability to implement national programs seamlessly. We are the name behind the most trusted brands in diagnostic testing and have worked in conjunction to offer novel platforms for consumers, including rapid emergency response. Our solutions provide the clinical, legal, and technology framework to facilitate large-scale consumer testing across key healthcare markets. Through integration with more than 45 national CLIA-certified labs and support of over 3,000 test types, we are shaping a new paradigm in healthcare, built around disease detection and prevention. We believe that empowering people with convenient access to clinically actionable testing has the power to change lives, improve outcomes, and create a healthier world. For more information, visit www.pwnhealth.com or follow @PWNHealth on Twitter and LinkedIn.

Contacts

Lisa Barbadora, Big Valley Marketing for Medable, +1 (610) 420-3413, media@medable.com
Tracie Bertaut, American Heart Association, +1 (504) 722-1695, tracie.bertaut@heart.org
Carolyn Walsh, Chief Commercial Officer, BioIntelliSense, cwalsh@biointellisense.com
Bob Borek, Head of Marketing & Strategic Partnerships, Datavant, pr@datavant.com
Wendy Ryan, Global Public Relations, Parexel, wendy.ryan@parexel.com
Marli Grossman, PWNHealth, +1 (716) 380-3708, mgrossman@pwnhealth.com