Your CRO partner for every step of your clinical investigation
Clinical investigations are a vital step in the development and regulatory approval of medical devices and digital healthcare products, such as Software as Medical Devices (SaMD), health apps, wearable devices, and telemedicine platforms. These investigations provide essential evidence regarding the safety and efficacy of these technologies before they reach the hands of healthcare professionals and patients.
What we offer:
- Study design & CIP development
- Site selection & patient recruitment
- Data collection and analysis
- Regulatory strategy, submission & compliance
- Monitoring and safety reporting
- Post-market Clinical Follow-up (PMCF) & surveillance
Why work with us?
Strong regulatory expertise:
Understanding of evolving regulatory requirements.
Proven experience in digital healthcare products:
Familiarity with the unique challenges of digital products.
Efficient resource management:
Ensuring cost-effective study execution.
Ability to conduct multi-center trials if needed.