Monitoring
Successful clinical trials rely on efficient clinical monitoring activities. CROPTZ ensures that our clinical research team members are trained prior to project assignment. In addition to their therapeutic knowledge, our clinical research associates (CRAs) perform source document verification to ensure that sites follow and adhere to protocol, good clinical practice and local regulatory requirements.
Why US
Our CRAs are proficient in clinical monitoring as well as local regulatory requirements. CRAs speak fluent English in addition to their native language. This facilitates the understanding of local culture and practices and enhances business proficiency.
At Pharmatrendz, we have a robust system that supports our CRAs and allows them to maximize their time to perform both traditional monitoring and risk-based monitoring. Each CRA is supported by a project manager and line manager to ensure their clinical monitoring competency and study-specific deliverables.
CROPTZ Essentials
A full range of monitoring services that are your assurance of successful clinical trials.
- Develop study management plan based on our project management capability.
- Conduct and write reports for the feasibility, initiation, interim monitoring, and site close visits.
- Discuss patient recruitment strategies and retention plan with site staff.
- Perform site visit according to monitoring plan and work with data management team to ensure data quality.
- Work with pharmacovigilance team to provide accurate safety information.