Two different methods are applied for these trials.
• Distant Monitorization (Data are collected via sponsor company and forwarded to OPTIMUM for data entry and analysis. Data query forms are prepared by OPTIMUM to resolve inconsistent and/or incomplete data)
• Direct monitorization (All data are collected and analyzed by Optimum CRO).
• For both of the above cases, Optimum ensures that LEC approval from coordinator is obtained and forwarded to MoH for its review.