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  • Supply chain(import /export study drug and or medical device, obtaining license, communication with RA, supply expedition to the site
  • Contract development, negotiation and execution
  • Regulatory set up (Submission for the Independent Ethics Committee (LEC) and Regulatory approval)
  • Patient Recruitment assistance (development of recruitment tools)
  • Site initiation and trial close-out operations
  • Independent monitoring
  • Trial-related documents archival and maintenance
  • Medical Monitoring/ Safety Reporting (SAE) to the Sponsor or CRO and the CA/CEC and RA
  • Data Protection Counseling
  • Management of Protocol Violations (Advising & alerting investigators of potential protocol violations)
  • Management of ICH GCP violations (Advising & alerting investigators of potential ICH-GCP violations)
  • Medical writing/Protocol Development and CRF Design
  • Development of Site SOP’s/Site Quality Assurance
  • Site training (ICH GCP, Regulatory, Ethics)
  • Data Management
  • Patent Protection Management
  • Feasibility Studies
  • Project Management