Clinical Safety

Safeguarding the health and well-being of participants while ensuring the integrity of the trial data is the heart of clinical trial safety measures and Ergomed’s mission. At Ergomed, we use advanced methodologies and technologies to identify potential risks early and implement mitigation strategies, enhancing participant safety and trial reliability.

Maintaining clinical trial safety is a regulatory necessity, and we are committed to the participants who contribute to the advancement of medical science. Ergomed’s experienced team of safety experts, who are dedicated to the well-being of trial participants, works closely with trial sponsors to develop customized safety management plans tailored to address the specific risks associated with each trial.

Our proactive approach includes continuous safety surveillance, detailed safety assessments, and timely reporting to verify compliance with global regulatory standards.

Our Clinical Trial Safety Services Include:

• Customized Safety Management Plans
• Safety Data Assessment
• Medical Review
• Signal Detection
• Aggregate Report Review
• Risk/Benefit Analysis
• Safety Database Solutions
• SAE (Serious Adverse Event), SUSAR (Suspected Unexpected Serious Adverse Event), and DSUR (Development Safety Update Report) Management

The complexity of modern clinical trials requires a robust safety infrastructure capable of handling diverse therapeutic areas and trial designs. Ergomed’s integrated safety solutions provide comprehensive support throughout the trial lifecycle, from early-phase studies to postmarketing surveillance. Leveraging our global presence and state-of-the-art safety systems, we deliver consistent, high-quality safety management services that protect participants and uphold the scientific validity of the trial outcomes.