Study Monitoring

APCRA provides comprehensive site monitoring and management. All monitoring activities are conducted in accordance with ICH GCP guidelines and applicable regulatory guidelines. APCRA develops a Sponsor-approved monitoring plan for each study. Monitoring visits are conducted at pre-determined intervals and/or as the study needs dictate.

Clinical site monitoring services include:

  • Site identification
  • Site initiation
  • Budget and contract negotiation
  • Regulatory document preparation and collection
  • Investigator meeting planning and presentation
  • Site personnel training
  • Interim site monitoring visits
  • Clinical study material accountability
  • Site closure
  • Manage project progress from start to finish