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Monitoring

Good clinical monitoring team is  essential to ensure that reported clinical data are accurate, complete and verifiable from source documents and the rights, safety and well-being of trial subjects are protected as well.

PharmaSich monitors have tremendous experience across many therapeutic areas. They are acquainted with special monitoring modes like risk-based monitoring, unblinded pharmacy monitoring etc. Our policy is not to hire CRAs with <2 years of pure monitoring experience.

Our monitors are highly educated. All of them have medical or pharma backgrounds.

Our CRAs are kept motivated by excellent conditions of work, flat hierarchy and competitive wages linked with their performance. The team is very stable – we have no significant staff turnover. Our CRAs know their job very well (experience!) and the minimal manager’s supervision are required. Line managers regularly discuss their CRAs’ performance with a client and follow up detected issues. That’s the way how we achieve fantastic results in the area of clinical monitoring.

Our Clinical Monitoring will ensure compliance with ICH/GCP principles, local regulations, Sponsor SOPs and provide:

-Qualification, initiation, interim monitoring and closeout visits at clinical study sites for data collection, source data verification, review of regulatory documents/files and drug accountability

- Efficient management of assigned study sites

- Appropriate training of site staff to ensure study protocol and regulatory compliance

-Smart resolution of any site issues during the course of a clinical trial

- Due handling of regulatory inspections

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