HPZenner CRO - The Clinical Research Organization
Office in Tübingen, Germany
| Your access to the world´s largest digital therapeutics reimbursement market |
DEUTSCH
HPZenner helps your Health App´s jumpstart into the world´s largest digital therapeutics reimbursement market
Germany’s healthcare market, the world's largest per capita spending health care system with 72 million socially insured patients has been opened for digital therapeutics (DTx) in October 2020. The internationally unique feature: DTx listed with Germany’s Federal Institute for Drugs and Medical Devices (BfArM) can be prescribed to patients by their doctor free of charge. The manufacturer receives payment directly from the health insurer. Those DTx carry the "DiGA" designation.
HPZenner Clinical helps you enter this unique market by providing you with the full scientific evidence to obtain the “DiGa” designation for your health app via BfArM´s "Fast Track" approval process
Your DiGA success is our mission
As a manufacturer-independent institute within the meaning of § 139e Paragraph 4 SGB V, HPZenner Clinical has the experience and knowledge for your DiGA success: With its DiGA Clinical Study Program (DCSP) HPZenner Clinical already made a significant contribution to the successful inclusion of some of the first DiGAs in the BfArM DiGA directory since October 2020.
An evaluation concept and study protocol for the BfArM have already been drawn up for other manufacturers.
Do not hesitate to call +44 7981 859 404 or to mail to london-office@hpzenner.com.
The CRO HPZenner®
is proud to have contributed significantly to the successful inclusion of some of the very first DiGAs in the BfArM directory. HPZenner is a Germany based CRO for the digital medical device industry. For manufacturers we offer full or partial service for clinical evaluations and clinical studies in Germany according to the German DiGAV as well as the EU MEDDEV 2.7/1 rev 4 / MDR.
| Analytical. Clinical. Innovative. |
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HPZenner® is a registered trademark.
