BUSINESS

PharmaCRO is the most competent and experienced CRO company to help with successful clinical trials and product registrations.

> BUSINESS > Clinical Operation

Clinical Operation

Based on the GCP, MFDS and ICH guidelines, we provide clinical trial services that save time and money with minimized risk. This is due to conducting project management and site management on the basis of our profound experience and expertise.

Our service includes

Project Planning

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

Medical Writing

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

Monitoring

  • Monitoring Plan
  • SDV(Source data verification)
  • Site staff training
  • Safety monitoring and so on