For each trial a dedicated team composed of experienced project manager and CRAs is assigned to conduct the study according to ICH/GCP, local regulations and SOPs. The following services are provided by OPTIMUM CRO in the scope of project management:
• Monitoring visits compliant with sponsor requests,
• Rapid information flow including significant monitoring findings,
• Detailed monitoring visit reports in a timely manner,
• Regular site contacts to track site needs, AE reporting and query resolution,
• Tracking trial site status via electronic follow-up system,
• Organization for and attendance to site audits that can be performed by sponsor and regulatory authorities,
• Close follow-up of study sites in terms of patient recruitment and retention.