Phase I

Operational Services

• Project Management
• Regulatory Services
• Drug Safety
• Biostatistics
• Data Management
• Medical Writing
• Quality Assurance

Medical Affairs

• Literature reviews, competitive landscape summaries, scientific papers, training
• Review of preclinical data packages
• Preparation of clinical development plans
• Preparation of Pre-IND and IND preclinical and clinical sections
• Phase I protocol design
• Medical monitoring

Clinical Pharmacology Unit (Noida, India)

• 80-bed facility with a volunteer database or more than 6,300 volunteers and a server-based Volunteer Data Management System
• Pharmacy
• Blood collection, separation and storage
• Types of studies conducted in unit:
  • BE Studies in healthy human male and female subjects
  • Studies in special populations
  • Bioavailability for NCEs
  • Drug Drug Interaction studies (DDIs)
• Full bioanalytical capabilities (HPLC, LCMS/MS) with validated methods