EmpiraMed Selected for Novel DTx Interventional Clinical Trial

Collaboration Combines the Best-In-Class Patient Engagement of Happify Health’s Digital Therapeutic and EmpiraMed’s Virtual Clinical Study Platform

EmpiraMed, Inc., a digital health technology leader in the field of Virtual Clinical Studies for Real World Evidence, 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.

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“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.”

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

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).

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