VisionHealth Clinical Trial Services


Hand in hand for an ideal study outcome

With clinical trials, the question often arises whether patients have been properly trained for studies, a product has been properly applied and the results are valid.
Our Kata app trains and controls the implementation of therapeutic measures and thus leads 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, ensure correct dosing and thus achieve better therapeutic outcomes and fewer side effects.

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

With Kata®, we create new possibilities for sponsors and CROs to optimally care for their patients in studies.

Rely on a strong team:

Our management has extensive experience in the fields of pharmaceuticals, medical technology and software engineering. We have also built a team with deep expertise in development and market access in digital health and respiratory medicine.

Our interdisciplinary clinical trial project team consists of a mobile app development team (frontend, backend, 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® meets all technical, regulatory and data protection requirements that qualify the app for use in clinical trials (eCRF compliant).
  • Kata® is registered as a Class I medical device under the European Medical Device Directive (MDD) and complies with the Good Clinical Practice (GCP) requirements necessary for the use of Kata® in clinical trials.
  • Kata® improves clinical trial outcomes: Kata® increases the likelihood of a positive clinical trial outcome and reduces overall costs.

Kata® offers UNIQUE features:

  • Inhaler trainer for all common inhalers to ensure optimal device handling in clinical trials
  • Easy to implement, no additional hardware required
  • Real-time inhalation reports and graphs
  • Access to patient inhalation reports, anytime, anywhere

Kata functions in detail:

  • Review and assessment of measurement results / inhalation assessment (according to respiratory league checklist or client requirements) of inhalation by algorithm OR by trained assessor.
  • Real-time feedback during inhalation
  • Monitoring of adherence AND correction of inaccurate administration of inhaled medication.
  • Thresholds of recorded data
  • Adherence markers
  • Client portal backend
  • Automatic data export & synchronisation
  • If required: implementation of client-specific needs

VisionHealth services in detail:

  • Daily recording and provision of clinical parameters of patients at home (symptoms, well-being, PFM, FEV1, emergency medication)
  • Ensuring therapy adherence in clinical trials
  • Training of correct inhalation technique for optimal lung deposition of inhaled medications
  • Adaptation of the Kata App to the specific needs of your planned study (e.g. implementation of patient questionnaires)
  • Project management
  • Training of study managers and staff
  • Service support
  • Data management and export
  • End-to-end validation
  • Timing and project plan according to the study protocol
  • Provision of study iPhones if required: uniform data collection without consuming patient data volume

Our partners:

Dr Med Kottmann CRO
Dr. Hans Werner Voß
Alcedis

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

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

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