PACTS expertise includes:

• Data Quality Management
  • Database Builds
  • Data Management
• Compliance
  • Clinical Quality Management System set-up 
  • GCP Auditing
  • Continuous Improvement
  • Inspection Readiness 
  • Inspection Preparation
• Clinical Operations
  • Trial Rescue Management
  • Trial & Project Management
  • Site Monitoring & Management
  • eTMF/eISF Management
  • Pharmacovigilance
  • DSMB/CEC Coordination
  • Medical Writing
  • Vendor Management

Therapeutic Area Experience includes:

• CNS
• Ophthalmology
• Vaccinology/Infectious Disease
• Cardiology

Other Relevant Experience:

• IND/NDA; IND/BLA; IDE/PMA; 510K
• Rare Disease; Genetic Disorders
• Cell Therapy; Gene Therapy
• Phase I-IV; Global; HEOR Studies