Our services

Start-up and Regulatory

• Site selection and qualification in accordance with Protocol and ICH GCP requirements
• Recruitment strategy
• Regulatory and Ethics Committee (EC) document preparation and collection, regulatory /EC documentation updates
• Investigator meeting organizing and presentation
• Ensuring protocol compliance and ICH-GCP adherence
• Document preparation for study submission for Ethics Committees and Regulatory Authorities
• Contract and budget negotiation between the investigational site and sponsor
• Review of informed consent forms and other study specific documents
• Initial study submission and all updates
• Clarification of regulatory requirements
• Individual support provided to investigational sites for their local submissions
• Communication with Ethics Committees and Regulatory Authorities throughout the trial
• Periodic reporting required by Ethics Committees and Regulatory Authorities on trial status and safety information