Regulatory authorities and payers increasingly recognise high-quality Patient-Reported Outcome data as a critical component of their decision-making process. Soon, market access of new drugs will not be possible without high-quality Real-World Evidence.
Our RWE generation engine bridges the gap between clinical trials and real-world usage by generating the evidence required to demonstrate the clinical value of new drugs and existing products.
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.
Our digital platform heartbeat ONE is a class 1 CE-marked medical device under the Medical Devices Directive 93/42/EEC.
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.
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.
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.
Your data collection can start as early as 90 days after signing provided all information governance and IT authorizations are in place.
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.
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.