Sunday, February 22, 2009

Clinical Monitoring

YOUR FIRST CHOICE FOR QUALITY, COST-EFFECTIVE ON-SITE MONITORING SERVICES

Ensuring that your trial has quality data, is compliant with all applicable regulations, and meets all timelines is a must for success.

Allow BMA field monitors to work with you and your clinical sites to help meet corporate and study timelines by providing monitoring support throughout all phases of a clinical trial. Our professional, industry experienced monitors will support your sites from feasibility through study closeout, as well as assist with audit preparation and submission support.

  • On-Site Monitoring Activities
  • Certified Field Monitors
    • ACRP
    • SoCRA
  • Site Feasibility, Qualification & Selection Support
  • Initiation, Interim and Closeout Visits
  • Source Documentation Review & Data Verification
  • Data Discrepancy/Query Support
  • Regulatory Compliance Support & Review
  • IRB Documentation Review
  • Site Preparation for FDA & Sponsor Audits
  • Participation & Presentation at Investigator Meetings
  • Enrollment Review
  • Identification & Addressing of Protocol Deviations & Violations
  • Study Supply Inventory
  • Reporting of Adverse Events & Serious Adverse Events


http://www.bmclaughlin.com/Clinical_Monitoring.html