You are here:: - » CRO

HPZenner CRO - The Clinical Research Organization

Offices in Tübingen, Germany, and in London, UK.

Your DiGA Market Access
Your access to the world´s largest digital therapeutics reimbursement market
London Office | HPZenner® Clinical Research Organization | +44 7981 859 404 |

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


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.

Welcome to the London Office

"We are proud of our renowned partners in all clinical disciplines who are the basis of our ability to pave the way for your DiGA success in Germany."


London Office
253 Goldhurst Terrace
London NW6 3EP, United Kingdom

HPZenner® is a registered trademark.

The MDR Clinical Evaluation For Your CE

Clinical Trials For CE Certification And BfArM