In addition to our platform, we also offer Professional services to help you even better!
ResearchManager Professional Services
Your roadmap to realization
With Professional Services we offer services for Medical Innovators with Medical Devices Classifications I, II, III within the TRL phases:
- TRL-6: Startups that have completed TRL-5 and progress to scale-up phase TRL-6 ‘Validation through clinical studies’. A clinical study in a relevant operational environment will have to validate the operation of the technology.
- >TRL-6: Startups and scale-ups that have completed TRL-6 and have entered the market introduction phase. Preferably, the product certification has already taken place and the product still needs to be refined by means of. a post-market survey (PMS).
In addition to providing a validated and secure platform for recording research data and everything related to the clinical research process, we also provide practical support for the preparation and implementation of clinical research.
We offer these services in close cooperation with the science office of STZ hospital Isala:
- Design and integration regarding study request and review processes
- Protocol development
- Epidemiology / statistics
- Reports
- Budget overview of study
- Setting up research question
- Study coordination
- Submit study at EC / IRB
- Auditing
- Monitoring
- Data collection
- Database setup
- Data management system (EDC)
- Data validation
- Project Management
- An operational environment with inclusions
- Medical writing
- Software for collecting data (EDC)
- Software for digitizing the process regarding study requests (CTMS)
- Providing WMO-GCP training
