Fast-track drug approval and market access

Our cost-effective, scalable Real-World Evidence generation engine brings together the clinical and patient perspectives to assess the clinical value and impact of your new drugs on an ongoing basis.
  • Collect high-quality, analysis-ready Real-World Data and generate RWE
  • Leverage our network of 200+ sites to kick start your data collection rapidly

A real-world platform for real-world data

Our heartbeat outcome measurement platform seamlessly integrates with hospital infrastructure and the day-to-day clinical workflows.

With data collected at the heart of the clinical practice, we provide you with treatment outcomes as they are truly experienced by patients.
  • Intuitive patient interface with built-in GDPR-compliant consent
  • Secure platform interoperable with major Electronic Health Record systems

Unlock outcome-based contracting

Our independent benchmarking platform facilitates the implementation of outcome-based contracting by generating reliable RWD and enabling transparency.


Rapidly generate real-world evidence of effectiveness with our modular infrastructure for continuous collection of real-world data.

Our RWE generation infrastructure bridges the gap between clinical trials and the real world. Get the right data at the right time while creating tangible value for hospitals and patients.


Our medical team will help you define suitable PRO endpoints and analysis methods to gain the insights you need.


The management and implementation of your project is overseen by a central office that provides the highest level of supervision and support.

Site Network

We help you to select your project sites and support the implementation of their outcome data collection for a rapid start.
Real-World Data from heartbeat was extremely valuable for our regulatory approval process.

Discussing results with their medical affairs team and receiving statistical analyses on follow-up questions was very helpful for us and will support our ongoing market access activities.
Senior Market Access Manager
Top 10 pharma company

Measure Outcomes. Deliver Impact.

We work across a broad range of medical specialties, please contact us if you work in a different field and require further information.


Monitor quality of life and treatment effects to increase overall wellbeing.


Evaluate treatment impact and monitor the recovery of patients with orthopedic conditions.

Mental Health

Improve mental health services quality by monitoring patients' quality of life and adjusting their treatments accordingly.

Spine Care

Evaluate treatment impact and monitor the recovery of patients with spine conditions.


Evaluate the impact of acute cardiac events on patients' quality of life and monitor the treatment of chronic conditions.

Other Areas

We work across a broad range of medical specialities.

Frequently asked questions

Need something that is not on this FAQ?

Our team will be happy to help, feel free to contact us directly.

What standards is heartbeat ONE compliant with?

Our digital platform heartbeat ONE is a class 1 CE-marked medical device under the Medical Devices Directive 93/42/EEC.

Where is the data stored?

Data can be stored locally (On-Premises) or on our dedicated servers (SaaS). For our SaaS solution, we currently work with two GDPR-compliant, certified data centers in Germany and Switzerland. Please inquire about additional hosting options in different locations.

  • Germany: the data center is ISO 9001 and ISO 27001 certified and additionally audited by TÜV Saarland.

  • Switzerland: the data center is ISO 5001 and ISO 27001 certified and additionally audited by Adsigo AG.

Who has access to the patient data?

Any identifiable patient data can only be accessed by designated individuals on the client’s side using a personal login and password. The patient data is stored securely; using 256 bit AES encryption.

For registries, clinical studies or further scientific evaluations an optional, separate consent needs to be provided by both the healthcare organization and the patient to share pseudonymized data with a third party including Heartbeat Medical. Our platform offers a GDPR compliant digital consent module for this purpose. 

Do I need a license to use the PROM questionnaires?

Some questionnaires may require a license or authorization from the developer to be implemented by your organization. Heartbeat can provide advice on cost-effective solutions and will support you obtaining the required authorization. The license holder is the client who is responsible for ensuring the payment of any license fee incurred.

When can I start collecting my PRO data?

Your data collection can start as early as 90 days after signing provided all information governance and IT authorizations are in place.

What languages does heartbeat ONE support?

Our interface supports multi-language implementation and is currently available in German, English and French. PRO questionnaires can be implemented in any language provided a validated translation exists. Please feel free to inquire about further language options.

What is the fee for heartbeat ONE?

Our pricing depends on several parameters and is a combination of fixed, one-off installation costs and an annual license. Please contact our team to discuss your project in more detail and obtain an accurate quote.