Get in touch to clinically validate your digital health solution
Learn more about how we can help your organization to efficiently validate your digital solutions in clinical environments. Once we’ll receive your request, our team will contact you to provide a response in a short period of time.
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Email *
Company *
Company website *
Company address
*
Contact person first name
Contact person last name *
Contact person phone number *
Brief company description 
Description of the solution you want to clinically validate
Number of employees
*
Indicate the country where your company's headquarters are located
*
Countries where your company operates
*
Required
Company type *
Technological support
*
Required
Indicate which of the following products of the Center are you interested *
In case it is a clinical validation: could you please indicate the objectives of the clinical
validation (end-points)? What is expected from the validation?
*
Levels of maturity of the solution
Please indicate according to the GAITS model (https://www.gaits.org/es/web/-digital-medicine/guidance):
  • Technologic
  • Regulatory
  • Market
  • Clinical
Added value of the solution
*
Required
Technical information *
Please indicate: 
  • Technology Functional Document (Software Functional Requirements)
  •  Technology roadmap (degree of maturity, plan, calendar, development phases of the different prototypes)
  • Technical requirements (technical description of the solution, catalogs, interoperability standards, architecture, etc.)
  • Service Level Agreement (SLA) (type of service to the user, support services, conditions and guarantees)
  • Checklist Digital Medicine Innovation Cycle (CIMTI).
  • Other supporting documentation on the level of maturity of the solution (ISO, quality standards, technical information for regulatory agencies, etc.)
  • User management (registration in the system, modifications, cancellations, integration with the HIS of the Hospital)
  • User authentication
Medical information
*
Please indicate:  
  • Analysis of the healthcare route to be modified (as is/to be, analysis of unmet needs, analysis of user vision, etc.)
  •  Scientific memory, executive summary, etc. (characterization of the problem, scientific objectives, etc.)
  • Population of users to whom the solution is directed, if it has been defined (pathology, age, socio-economic level, etc.)
  • Enrollment of the patient planned or carried out in previous experiences (inclusion flow, inclusion criteria, etc.)
  • Previous scientific production (including other clinical areas)
Statistics
*
Please indicate if there are previous experiences (patient sample required, type of statistical analysis required if it has been carried out previously).
Ethical, legal aspects
*
Please indicate:   
  • Model agreement with Hospitals
  • Data processing agreement models
  • Specific regulation on medical device and others that apply to specific technology and processes)
  • Planned management of personal data processing LOPD: 1) Privacy Impact Assessment (external accreditation); 2) Other risk assessment documents.
Economic aspects
*
Please indicate if  there are any previous scientific production on cost-effectiveness studies (including other
clinical areas).
A copy of your responses will be emailed to the address you provided.
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