Course Agenda
Day One  (8:30 AM-4:30 PM)

8:00 – 8:30 AM: Registration

8:30 – 10:15 AM: Session I
  • Drug development process
  • Clinical research using active clinics
  • Project life cycle

10:15 – 10:30 AM: Break

10:30 – 12:00 noon: Session I Continued
  • Project Constraints
  • Risk assessment, planning and management

12:00 – 1 PM: Lunch

1– 2:30 PM: Session II
  • Review a protocol
  •  Learn about recruitment, data collection, quality and spend vs. budget information
  • Identify vendors in collaboration with supply management and clinical team

2:30 – 2:45 PM: Break

2:45 – 4:30 PM: Session II Continued
  • Establish the study budget
  • Prepare recruitment projection and select countries and sites
  • Review and approve protocol related documents (ICF, Monitoring, Quality Plans, CRF’s, e-CRF’s)
Day Two  (8:30 AM-4:30 PM)

8:30 – 10:15 AM: Session III 
  •  Review and approve contracts, direct and indirect fees of final proposals
  • Manage study team meetings and interact with key interfaces such as pharmacovigilance, medical affairs, marketing and regulatory
  • Best Practices for Investigator meetings

10:15 – 10:30 AM: Break

10:30 – 12:00 noon: Session III Continued
  • Manage investigators and site administrators
  • Develop and monitor Key Performance Indicators (KPIs) to track the progress of the ongoing trial
  • How to keep all the study related manuals completed and updated
  • Effectively manage the study budget and vendor payments

12:00 – 1 PM: Lunch

1 – 2:30 PM: Session IV
  • Regulatory approval for clinical trials (IND and IDE applications)
  • Multi-national trial approval

2:30 – 2:45 PM: Break

2:45 – 4:30 PM: Session IV Continued
  • IRB and IEC approvals
  • Regulatory risk management
  • Crisis Management for clinical trials