Implementation

Project management

  • Project and task planning
  • Project supervision
  • Providing timelines
  • Budgeting
  • Trial master file
  • Study coordination
  • CRAs
  • Providing progress reports
  • Medical monitoring and reporting adverse events and serious adverse events

 

 Clinical trial reporting and approval

  • Regulatory classification of clinical trial projects
  • Clinical trial application (CTA) for national and multi-center clinical trials
  • Clinical trial application and communication with Iranian authorities ( Ministry of Health: Deputy of treatment, Food and drug organization, Health Technology assessment office) and other national authorities
  • Clinical trail application to ethics committees and corresponding communication
  • Reporting obligations with supervisory authorities
  • Management of amendment notifications
  • Communication with insurance providers
  • Safety reporting
  • Clinical trial registration

 

Quality management

  • Internal quality management
  • Implementation of audits (incl. study site audits)
  • Support during inspections
  • Within the framework of clinical trials: support regarding the implementation of GCP and Iran regulations

Medical writing

  • Writing study protocol, patient information sheet and informed consent form
  • Writing Monitoring plan, safety plan, data management plan
  • Article writing

Monitoring and site management

  • Preparation of study site based on regulations (preparing required documents, providing standard requirements, etc.)
  • Preparation of study site documentation (Trial Investigator File / Investigator Site File)
  • Pre-study and initiation visits
  • Periodic monitoring (in-house and on-site) including source data verification according to the monitoring plan, close-out visits, study site support
  • Communication with the study sites
  • Checking Internal Consistency of CRF Data
  • Monitoring of Enrollment Rate and Patient Eligibility Criteria
  • Site Closure

Data management

  • Development of study-specific case report forms in close cooperation with study coordinators
  • Designing CRF or e-CRF
  • Randomization
  • User training and support
  • Data validation
  • Query management
  • Data preparation for interim and final reports