With board-certified medical expertise, we conduct clinical trials, clinical evaluations and health-economic analyses for the medical device and pharmaceutical industries as well as for university hospitals — in accordance with ISO 14155, MEDDEV 2.7/1 rev. 4, MDR and DiGAV.
Clinical Excellence
Our Services
As a CRO, we pave the way to market for your medical device or pharmaceutical — from study planning to regulatory-compliant documentation.
Clinical trial unit for pharmaceuticals and medical devices: submissions to BfArM and ethics committees, conduct, monitoring, statistical analysis and ICH-compliant reporting — through to publication.
Learn more →CER and CEP according to MDR and MEDDEV 2.7/1 rev. 4 — performed by board-certified physicians per Art. 6. Seven proprietary implementation modules from gap analysis to PMS/PMCF.
Learn more →Into the DiGA directory with HPZenner: as a manufacturer-independent institute, we have contributed substantially to the successful listing of several DiGAs in the BfArM directory.
Learn more →Health-economic assessment of digital technologies, AI and DiGA: cost-effectiveness, reimbursement, scalability and sustainable integration into healthcare.
Learn more →Tailor-made modules: clinical writing, CER training, manufacturer support from A to Z, G-BA/NUB procedures, plus process and quality optimisation.
Learn more →HPZenner’s digital health corporate venture builder: digital product development and set-up of your QM system according to ISO 13485 and ISO 27001 for healthcare start-ups.
Learn more →The Institute
The HPZenner® Clinical Research Institute is an independent CRO based in Tübingen, Germany. We document the patient benefit of medical devices through evidence-based investigations, scientific research and clinical knowledge.
Together with manufacturers, we follow society’s mandate for the future: caring not only for today’s patients but, through medical innovation, for future generations as well.
Research & Development
Digital therapy for peripheral vertigo: a multimodal programme of sensorimotor training, CBT, medical counselling, PMR, autogenic training and health education.
Funded by the European Space Agency: development of a DTx for the prevention and treatment of space sickness before, during and after spaceflight.
Talk to us about your clinical trial, your clinical evaluation or your DiGA’s path into the BfArM directory.
Or directly: office@hpzenner.com · +49 7071 704 3012