Does your trial require an experienced Clinical Research Professional who initiates all set-up activities to conduct a trial, obtains the relevant input from an interdisciplinary team of the sponsor while ensuring collaboration across the trial team? Do you need an experienced Clinical Research Professional who manages a smooth set-up, a successful enrollment and treatment phase as well as a proper close-out of the trial? Find out more about our services from which your organisation can benefit.

The clinical project management services include

• Trial management of trials phases 1- 4 and NIS
• Preparation and review of trial documents such as
  • Clinical trial protocol
  • Informed consent
  • Monitoring tools
  • Case report forms
  • Monitoring plan and manual
  • Clinical trial reports
  • etc.
• Preparation of submissions to IRB/IEC and CA
• Monitoring and ensuring to meet defined timelines and allocated budget
• Collaboration with and management of vendors
• Conduct global trial team meetings
• Tracking of the trial status and proactive communication of any issues
• Ensure adherence to ICH/GCP-guidelines and local law and regulations
• Ensure adherence to Standard Operation Procedures (SOPs) of the client
• Ensure inspection readiness and provision of support during an audit
• Review and maintenance of trial master file and country files
• Conduct co-monitoring visits for training or quality assurance
• CRA-training
• Review of monitoring reports
• Conducting investigator meetings