MFDS및 ICH규정을 토대로 숙련된 인력과 풍부한 경험을 바탕으로 임상시험의 전체적인 Project & Site Management 를 진행하여 시간과 비용을 절약하고 위험을 최소화할 임상시험 서비스를 제공하고 있습니다.

Based on MFDS and ICH regulations, we provide clinical trial services that save time and cost and minimize risks by conducting overall Project Management and Site Management with our skilled expertise and experience.

▶  Project Management
▶  Site & Investigator Selection
▶  Pre-Study Visit
▶  Investigator Meeting
▶  Initiation Meeting
▶  Close-Out Visit
▶  TMF/ISF/PF management

▶  Monitoring Plan
▶  SDV(Source Data Verification)
▶  Site staff training
▶  Safety monitoring and so on

▶  Protocol & CRF/EDC development
▶  IB writing
▶  CSR writing
▶  TMF/ISF/PF management
▶  IRB Package Preparation, submission and follow up