KasaConsult bvba
Ernest Ourystraat 5A bus 6
B-3320 Hoegaarden
Belgium
Tel +32 (0)16 80 81 51
Fax +32 (0)16 80 81 61
portal(at)kasaconsult.com
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- Audits of monitoring process to inspect compliance, knowledge of protocol and procedures, interaction with sites, skills and competencies
- Audits of regulatory submission documentation for correctness and completeness
- Audits of document flow and management in-house (trial master file), at vendor (vendor specific shadow files) and on-site (investigator binders)
- Audits of external vendors to inspect certificates, accreditations, GXP and protocol compliance, quality and SOP system
- Write and implement SOPs complying with GCP standards, ICH and FDA
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