PILOT AND CLINICAL VALIDATION STUDIES
In order to validate the efficiency and effectiveness of a developed solution in real-life environments, the HCLLC organizes and executes pilot studies and clinical validation studies with the collaboration of the health and social entities associated to the network. The results obtained from these studies allow the validation of solutions efficiently and quickly, with a statistical sample that allows to generate evidence with significant results and with a minimum budget. This information is essential to focus investment rounds and regulatory processes.
The HCLLC covers all areas of the healthcare field, thanks to its extensive network of collaborating entities. The support from the HCLLC includes:
• Identification of participants for the study (unicentric or multicentric).
• Support in the delivery of the necessary documentation for the ethical committee.
• Support throughout the entire study.
PILOT AND CLINICAL VALIDATION STUDIES EXAMPLE
THE COMPANY
E-HEALTH TECHNICAL SOLUTIONS has developed WIVI, a new immersive product based on 3D visualization which allows a comfortable and free way to assess the skills and capabilities of the visual system as well as the design and implementation of treatment by appropriate vision training for improvement and standardization.
E-HEALTH TECHNICAL SOLUTIONS has developed WIVI, a new immersive product based on 3D visualization which allows a comfortable and free way to assess the skills and capabilities of the visual system as well as the design and implementation of treatment by appropriate vision training for improvement and standardization.
THE NEED
At the advanced stage of development that WIVI was in, their need was to validate the results, previously obtained in preclinical studies, with a clinical validation study.
THE ACTIVITIES
The HCLLC organized a prospective observational study in collaboration with the Paediatrics Research Group at Consorci Sanitari de Terrassa. The sample size included 200 children divided into two groups, children with healthy visual function and children with visual dysfunctions diagnosis.
THE ACHIEVED MILESTONES
• Feedback regarding methodology, clinical protocol, and study implementation.
• Submission and approval by an Ethical Committee.
• Validation of the solution with the end users.
• Feedback from healthcare professionals using the solution.
• Submission and approval by an Ethical Committee.
• Validation of the solution with the end users.
• Feedback from healthcare professionals using the solution.
PHOTO GALLERY
