Clinical Monitoring and Project Management: Comprehensive Oversight
We provide end-to-end clinical monitoring and project management services to ensure the smooth operation of clinical trials, from site initiation to closure. Our local and global expertise ensures effective oversight, compliance, and high-quality data collection throughout the study lifecycle.
- Local and Global Project Management
We offer comprehensive project management services for both local and global clinical trials. Our experienced team ensures seamless coordination between sponsors, sites, and regulatory bodies, keeping studies on track, within budget, and in compliance with regulations.
- Onsite and remote monitoring of investigational sites
We conduct both onsite and remote monitoring to ensure investigational sites adhere to study protocols, regulations, and Good Clinical Practice (GCP). Our flexible approach allows for efficient oversight while maintaining data quality and patient safety.
- Partial and full source data verification
Our team performs partial or full source data verification (SDV) to confirm that clinical data recorded in case report forms matches the original patient records. This ensures the accuracy and integrity of trial data, critical for regulatory submissions.
- Site and patient recruitment support
We provide proactive support for site and patient recruitment, helping to identify the most effective strategies to reach enrollment targets. This includes offering insights on site performance and patient outreach to accelerate recruitment timelines.
- Site Closure Activities
We manage all site closure activities, ensuring a thorough and compliant closeout process. This includes final data collection, reconciliation of study materials, and preparation of final reports, ensuring the trial is properly concluded and regulatory obligations are met.