Partners

Clinical trials services

Working hand in hand for an optimal study outcome

In clinical research, the question as to whether patients have been properly trained for studies, a product has been properly applied and the results are valid, often arises.

Our Kata® app trains and controls the implementation of therapeutic measures, leading to consistent results that can be used by sponsors, research institutes and CROs for new approaches and developments. With Kata® technology, we can improve adherence and ensure proper dosing, resulting in better therapy outcomes and fewer side effects.

VisionHealth combines medical expertise and technical know-how with a clear vision.

Lean on a strong team:
Our management has extensive experience in pharmaceuticals, medical technology and software engineering. In addition, we have built a team with deep expertise in development and market access in digital health and respiratory care.

Our interdisciplinary clinical trial project team includes a mobile application development team (front-end, back-end, UX), product owners, product managers, regulatory consultants, and project managers to ensure the full success of the trial.

What are the benefits of Kata® in clinical trials?

Kata® improves clinical trial outcomes: Kata® increases the probability of a positive clinical trial outcome and reduces overall costs.

Kata makes important patient safety parameters continuously available to the treating study physician, even outside of study visits.

Kata® complies with all technical, regulatory and data protection requirements that qualify the app for use in clinical trials (ISO 13485, DSGVO, GCP).

Kata® functions

Review and evaluation of measurement results / inhalation assessment (according to respiratory league checklist or customer requirements) of inhalation by algorithm OR by trained assessor.

Ensuring the correct administration of inhaled medications

Verification of therapy adherence according to the specifications of the study protocol

Day-by-day recording and provision of patient clinical parameters at home (symptoms, well-being, PFM, FEV1, emergency medication)

Synchronization of the data with the eCRF

VisionHealth services in detail

Adaptation of the Kata® App to the specific needs of your planned study (e.g. implementation of patient questionnaires, customization of the diary function, etc.)

Ensuring therapy adherence in clinical trials

Project management

Training of study sites, study directors, and healthcare professionals

If needed: provision of study iPhones for uniform data collection without consuming patient data volume

Dr. Hans Werner Voß
Director Clinical Operations
CTO Dr. med. Kottmann GmbH & Co KG, Hamm, Germany

“There are hundreds of inhalatives for the treatment of respiratory diseases with a multitude of device-specific operations and resulting potential operating errors. Permanent operating errors are very likely to influence therapeutic efficacy. I anticipate that the Kata® App may reduce the likelihood of false negative results in clinical trials.”