Clinical Trial Safety
Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide
- SAE & SUSAR processing
- Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
- Safety data review in clinical protocols
- Safety Management Plans (SMPs) and start-up documentation
- EDC integration (eSAE tool)
- Communication with investigators and clinical team
- SAE reconciliations
Case Processing & Data Management
Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide
- SAE & SUSAR processing
- Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
- Safety data review in clinical protocols
- Safety Management Plans (SMPs) and start-up documentation
- EDC integration (eSAE tool)
- Communication with investigators and clinical team
- SAE reconciliations
Aggregate Reporting & Risk Management
Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide
- SAE & SUSAR processing
- Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
- Safety data review in clinical protocols
- Safety Management Plans (SMPs) and start-up documentation
- EDC integration (eSAE tool)
- Communication with investigators and clinical team
- SAE reconciliations
Signal Detection & Safety Surveillance
Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide
- SAE & SUSAR processing
- Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
- Safety data review in clinical protocols
- Safety Management Plans (SMPs) and start-up documentation
- EDC integration (eSAE tool)
- Communication with investigators and clinical team
- SAE reconciliations
Post-Marketing Safety & Regulatory Compliance
Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide
- SAE & SUSAR processing
- Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
- Safety data review in clinical protocols
- Safety Management Plans (SMPs) and start-up documentation
- EDC integration (eSAE tool)
- Communication with investigators and clinical team
- SAE reconciliations
Safety Systems & Technology Management
Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide
- SAE & SUSAR processing
- Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
- Safety data review in clinical protocols
- Safety Management Plans (SMPs) and start-up documentation
- EDC integration (eSAE tool)
- Communication with investigators and clinical team
- SAE reconciliations