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As a Regulatory Affairs & Clinical Operations Manager I can provide you with an extensive network of experienced and ICH GCP R2 trained CRAs operating on pan-European level. All CRAs are fluent in English. Monitoring models are based on pre-established and study-specific combinations of on-site visiting schedules as well as remote data review. A risk-based adaptive approach in the monitoring activities ensure efficient and cost-effective study oversight.
Detailed procedures and study specific communication plans ensure prompt issue escalation, management and follow-up until resolution.