Clinical Trial Monitoring
The new ICH GCP Guidelines published in November 2016 have heralded more regulatory support for risk based clinical trial monitoring as a standard, quality focused approach to monitoring. Pacific-Link Consulting monitors with a risk based, patient focused approach for clinical monitoring which is compliant with the risk based approach advocated in these new guidelines. Pacific-Link Consulting’s approach focuses on detecting, mitigating and preventing errors which could lead to risk and impact to quality data. Our highly skilled monitors proactively identify and manage the range of risks that arise in modern, multi-center clinical trials.
Pacific Link Consulting offers the following services for clinical trial monitoring:
- Oversee data collection
- Develop monitoring plans
- Ensure accuracy of data
- Provide trial monitors
- Review source documentation and case report forms
- Ensure regulatory compliance
- Resolve data queries
- Conduct interim analyses as requested by clients
- Provide oversight
- Ensure procedures are consistent and safe for each participant throughout the trial
- Participate in oversight committees
- Central monitoring
- Ongoing statistical analysis of data to ensure accuracy and detect errors or unusual data patterns
- Data quality verification
- Onsite monitoring
- Risk-adapted monitoring
- Risk assessment
Other Clinical Trial Services
Pacific Link Consulting can file Clinical Trial Applications (CTAs) in Canada on a clients’ behalf. We can help the client obtain legal authorized representative for the region, project manage your CTA, write and prepare meeting requests as well as meeting packages.
Other markets of expertise include Japan and Europe.
Please contact us to learn more about what Pacific-Link Consulting can do for your project.