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Clinical Monitoring Services
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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