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Clinical Monitoring Services

Quality monitoring is pivotal to the success of a clinical trial, and BIOTECH Consultancy Services is dedicated to providing quality clinical research for all of your study monitoring needs. We provide project level monitoring services for a complete clinical trial or supplemental monitoring services to meet our clients varied needs. Our professionals conduct all clinical monitoring activities under GCP standards and adhere to FDA regulations, ICH guidelines, and the SOPs of our individual clients.

Monitoring Services
  • Investigator qualification
  • Site selection and investigator enrollment
  • Pre-study document collection and review
  • Site initiation and training
  • Site maintenance (interim study visits)
  • Source document
  • Regulatory documentation updates
  • Site visit reports
  • Site termination/closeouts
  • Study site GCP auditing
Project Level Management Services
  • Organize schedule of events and assignment of tasks to appropriate personnel
  • Coordination monitoring and clinical research associate activities
  • Provide management reports to Sponsor regarding project
  • Manage accounting and budget-related tasks for project
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