Monitoring

Quality assurance in real time – for reliable study data

 

Our professional monitoring guarantees that your study is conducted in accordance with GCP and applicable regulatory requirements, on time and with the highest data quality, whether on-site or remote.

Monitoring strategy

• Risk-based monitoring (in accordance with ICH GCP)
• Customized monitoring plan (number/type of visits, focus parameters)
• Centralized monitoring via EDC system (real-time data check)

Monitoring visits (on-site or remote)

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

Quality controls

• Data plausibility checks in real time
• Query management

Why work with us?

• Experienced monitors (CRA) 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."