Global clinical expertise with local, quality monitoring and project management.
General information on clinical investigation services
Because medical device clinical investigations are highly specific, our team of experienced, multilingual monitors and project managers are exclusively dedicated to medical devices and work according to our certified ISO 9001 quality system while taking into account cultural nuances to save you critical time and resources for clinical investigation management throughout Asia, Europe, South America and the Middle East.
- Global clinical strategy development including reimbursement
- Clinical evaluation report writing
- Protocol design and development
- Investigator brochure writing
- Instructions for use
- Case report form development
- Compliant informed consent
- Site selection
- Investigator meetings
- Clinical trial agreements
- Regulatory and Ethics Committee submissions
- Clinical project management
- Product training
- Site monitoring
- Site management (CRC)
- Medical monitoring – Safety reporting
- Clinical report writing
- Data management and statistics
- Clinical auditing
- Data Protection (GDPR) Compliance services – certified DPO.
- Legal representative
Clinical Investigations in China and South East Asia
Specialised team who truly know the ins and outs of conducting clinical investigations in their countries. Our experts in Beijing ensure a successful access to the Chinese market by:
- Determining data required for China market access – type of clinical investigation, how many patients and which investigators
- Site selection especially primary investigator are highly important in China – our local team has access to many Key Opinion Leaders willing to participate in your study
- Legal representative during clinical investigations
- Efficient setup and management of your clinical investigation
- Auditing of clinical investigations especially to prepare for NMPA site inspections
- Easy usable data bases – multilingual where required
- Biostatistics services that understand China requirements
- Full service for market access
Experts throughout South East Asia can cover your clinical investigations in their regions. We ensure compliance to ISO 14155:2020 so you can use data for registration in other territories. We help you optimize the many opportunities of conducting clinical investigations in Asia!
Contact us for a free half-hour consultation