EmpiraMed Selected for Novel DTx Interventional Clinical Trial

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MAYNARD, Mass., Aug. 10, 2021 /PRNewswire/ -- EmpiraMed, Inc., a digital health technology leader in the field of Virtual Clinical Studies for Real World Evidence, today announced that Happify Health selected EmpiraMed to perform the interventional clinical trial for their Ensemble investigational prescription digital therapeutic (DTx) for the purpose of FDA regulatory approval consideration.

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Retrieved on: 
Tuesday, August 10, 2021
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Wellness, Combination, GDPR, Community, Industry, Therapy, CEO, Pharmacy, Software, Contract, Takeda Oncology, Disease management, Organization, DCT, Title 21 CFR Part 11, CVS Health, Solution, Patient, Clinical trial, Real, GCP, Single-frequency network, Mental health, Research, Digital, Compliance, Health, HIPAA, Real world evidence, RWE, Method, Acacia, Janssen, Optum, FDA, Merck & Co., Medical device, Pharmaceutical industry
Geotags: 
Massachusetts
Organisation: 
EMPIRAMED, INC.
Website: 
http://www.EmpiraMed.com
Summary
Key Points: 
  • MAYNARD, Mass., Aug. 10, 2021 /PRNewswire/ -- EmpiraMed, Inc., a digital health technology leader in the field of Virtual Clinical Studies for Real World Evidence, today announced that Happify Health selected EmpiraMed to perform the interventional clinical trial for their Ensemble investigational prescription digital therapeutic (DTx) for the purpose of FDA regulatory approval consideration.
  • The trial has been deployed using the EmpiraMedTM PRO PortalTM Software Platform and patient recruitment has commenced.
  • EmpiraMed was selected because their virtual study platform has a proven high patient engagement track record.
  • EmpiraMed is a digital health technology company that performs post-market, prospective, Virtual Clinical Studies to generate Real World Evidence for the Life Science Industry.


EmpiraMed Selected for Novel DTx Interventional Clinical Trial

MAYNARD, Mass., Aug. 10, 2021 /PRNewswire/ -- EmpiraMed, Inc., a digital health technology leader in the field of Virtual Clinical Studies for Real World Evidence, today announced that Happify Health selected EmpiraMed to perform the interventional clinical trial for their Ensemble investigational prescription digital therapeutic (DTx) for the purpose of FDA regulatory approval consideration. The trial has been deployed using the EmpiraMedTM PRO PortalTM Software Platform and patient recruitment has commenced.

Interventional Trial Integrates Behavioral Health Telemedicine with RW Patient Experience to Accelerate DTx Approvals

"EmpiraMed has demonstrated that they are collaborative, agile, and adaptable, which is ideally suited to the dynamic DTx industry," according to Acacia Parks, Chief Science Officer of Happify Health, who added, "EmpiraMed's innovative technology and methods allowed us to implement a study design that is novel, clinically rigorous, and offers study participants a very compelling user experience."

EmpiraMed was selected because their virtual study platform has a proven high patient engagement track record. Greg Erman, President & CEO of EmpiraMed said, "Patients and clinicians will see great synergy between EmpiraMed's remarkable patient engagement rates for clinical research and Happify Health's own exceptional patient experience for the administration of Ensemble."

Ensemble is the first and only transdiagnostic prescription DTx for the treatment of patients who have Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD). Patients can learn more about participating in this trial and getting access to Ensemble by visiting https://getensemble.com/.

About EmpiraMed

EmpiraMed is a digital health technology company that performs post-market, prospective, Virtual Clinical Studies to generate Real World Evidence for the Life Science Industry. We sit at the intersection of DCT (Decentralized Clinical Trials) and RWE. Formed in 2011, we pioneered the methods and delivery of 100% site-less virtual studies. Our software products help manufacturers demonstrate real world value and comparative effectiveness to prescribers; produce evidence for expanding market access; deliver more efficient methods to meet FDA mandates for Phase IV Long Term Follow-Up studies; deploy patient-centered rare disease registries; and, support more rapid regulatory approval of new indications and label extensions using real world data. Our services are novel and differentiated through an automated rules-engine for agile study deployment; complete mobile device independence; the largest specialty pharmacy network for patient recruitment in the industry; a complete clinical research gamification and incentivization system to boost patient engagement; and, a patient-centered method of capturing clinic data without the burden, expense, or delays related to clinical trial research agreements. We are proud that our studies average 80% monthly survey compliance which is over 3X the industry benchmark for noninterventional clinical studies. Our software and services are internationalized, localized, and support all industry compliance requirements including HIPAA, GDPR, GCP, and 21 CFR Part 11. Our customers have included global biopharmaceutical leaders such as Merck Sharp & Dohme, Janssen, Sanofi Genzyme, and Takeda Oncology. We also have contracts with novel patient recruitment channel partners including leading specialty pharmacies such as CVS Health and Optum, international Patient Advocacy Groups such as LUNGevity, academic research centers, disease management call centers, and organizations to support direct-to-patient eRecruitment. Please visit http://www.EmpiraMed.com for more information.

About Happify Health

Happify Health is a global software-enabled healthcare platform. We design and deploy software to help improve mental health, physical health and well-being. We are creating a future where better health outcomes can be powered by technology—leading to more personalized care that can improve the everyday lives of more people.  The Happify platform offers a full spectrum of science-backed Digital Therapy and Care Journey solutions for customers and individual end-users; including Wellness, AI-based Coaching, Community, as well as Combination and Prescription Digital Therapeutics.

Our patient solutions are disseminated through unified products and services we deploy for the healthcare ecosystem; including enterprises, health plans, health systems, pharma and medical device manufacturers. Our global platform is available in 10 languages, supports more than 10 chronic conditions, and covers more than 20 million lives. For more information, visit www.happifyhealth.com.

Cision View original content:https://www.prnewswire.com/news-releases/empiramed-selected-for-novel-dtx-interventional-clinical-trial-301351616.html

SOURCE EmpiraMed, Inc.

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