Monitoring

Real-time quality assurance – for reliable study data

Our professional monitoring ensures your study complies with GCP and all regulatory requirements, while maintaining highest data quality and timely execution – whether on-site or remote.

Monitoring strategy

• Risk-based monitoring (in accordance with ICH GCP)
• Customized monitoring plan (visit frequency/types, focus parameters)
• Central monitoring via EDC system (real-time data verification)

Monitoring visits (on-site or remote)

• Site initiation visit (SIV)
• Regular control visits (SDV – Source Data Verification)
• Close-out visit

Quality controls

• Real-time data plausibility checks
• Query management

Why choose us?

• Experienced monitors (CRAs) with extensive study expertise
• Flexible models – from 100% on-site to hybrid monitoring

 "We don't just monitor data – we ensure the success of your study."