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Q-TRIALS
TRIAL SIMULATION
Trial Simulation
Close–Out
Follow-Up
Treatment
Patient Recruitment
Study Initiation
Primary Submissions
Feasibility & Site Selection
Feasibility & Site Selection
 Using our connections with leading
investigators
 Estimating recruitment and treatment
potential
Primary Submissions
 Preparing submission packages
 Correspondence with MoH and local
committees until approvals are granted
 Translations
 Import of investigational product and lab kits
Study Initiation
 Initiating all sites
 Investigational product and lab kits distribution
Patient Recruitment
 Monitoring recruitment and consent process
 Coordinating collections of biological samples
for a central laboratory
 Ensuring achievement of recruitment goals
Treatment
 Monitoring
 Coordinating collections of biological samples for
a central laboratory
 Monitoring pharmacy, patient
randomization, prescriptions
 Ensuring site compliance or reporting deviations
 Ensuring achievement of treatment goals
 Interim submissions and reports
 Import and distribution of investigational product
and lab kits, return to depot and destruction
 Translations
Follow-Up until Close–Out
 Follow-Up
 Monitoring – patient FU process and site
adhering to timelines
 Ensuring closure of all queries and pending
issues
 Closing pharmacy and investigational product
return to depot
 Closing site and collecting all data
 Close-out submissions

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Q trials trials simulation

  • 2. Trial Simulation Close–Out Follow-Up Treatment Patient Recruitment Study Initiation Primary Submissions Feasibility & Site Selection
  • 3. Feasibility & Site Selection  Using our connections with leading investigators  Estimating recruitment and treatment potential
  • 4. Primary Submissions  Preparing submission packages  Correspondence with MoH and local committees until approvals are granted  Translations  Import of investigational product and lab kits
  • 5. Study Initiation  Initiating all sites  Investigational product and lab kits distribution
  • 6. Patient Recruitment  Monitoring recruitment and consent process  Coordinating collections of biological samples for a central laboratory  Ensuring achievement of recruitment goals
  • 7. Treatment  Monitoring  Coordinating collections of biological samples for a central laboratory  Monitoring pharmacy, patient randomization, prescriptions  Ensuring site compliance or reporting deviations  Ensuring achievement of treatment goals  Interim submissions and reports  Import and distribution of investigational product and lab kits, return to depot and destruction  Translations
  • 8. Follow-Up until Close–Out  Follow-Up  Monitoring – patient FU process and site adhering to timelines  Ensuring closure of all queries and pending issues  Closing pharmacy and investigational product return to depot  Closing site and collecting all data  Close-out submissions