Where engineering backgroundmeets clinical know-how
Medidee’s CRO (Clinical Research Organisation) services are backed up by decades of experience in the fields of medical device engineering, quality and regulatory affairs. This unique combination of all relevant competences supports all aspects of your project in the most complete and comprehensive manner. Discover here an example of a clinical study set-up.
We support you in any of these CRO activities
- Identification of relevant clinical endpoints pertinent to safety AND/OR performance of the device
- Definition of clinical study type (e.g. superiority, non-inferiority, equivalence)
- Sample size considerations
- Statistical Analysis Plan (SAP) definition
- Compilation of the Clinical Investigation Plan (CIP) in compliance with the Good Clinical Practice principals defined in ISO 14155
- Assembly of Investigator’s Brochure
- Selection of Clinical Study Site
- Structure of eCRF architecture
- Compilation of other relevant components of the Trial Master File (TMF)
- Interactions with Regulatory Authorities (Notified Bodies, National Competent Authorities, Ethical Committees)
- Submission of Clinical Trial Application (CTA)
- Registration of a clinical study in national registries
- Management of amendments
- Performance of initiation visit
- Study monitoring (following risk-based approaches and state-of-the-art practices)
- Study close-out
- Support with Authorities inspections
- Implementation of a Data Monitoring Committee
- Classification of Adverse Events and Device-related deficiencies
- Serious Adverse Event (SAE) reporting
- Periodic safety reporting
- Audit of clinical study site
- Audit of clinical procedures
- Audit of mandated contract research organization (CRO)
- Identification and qualification of service suppliers (CRO, logistics, insurance etc.)
- CDM Plan compilation
- Database set-up
- Clinical data analysis
- Clinical Investigation Report (CIR) compilation
- E-CRF solution
Need some support?
Medidee is an End-to-End MedTech CRO. From Clinical Strategy to trial design, approval, execution, and reporting, we are here to help you!