Over the last 10 years, clinical trials have changed substantially in response to increasing globalization and study complexity, along with new technological capabilities and industry guidelines 7.

Please define the meaning of “risk” from the perspective of environmental monitoring. Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with ...

Risk-based monitoring (RBM) is an evolving concept in the clinical trial industry that is transforming the ways trials are done. So what is risk-based monitoring? We had a chance to speak with Andy ...

According to EY, 98% of U.S. financial services firms use third parties to fast-track offerings and fulfill customer journeys. That’s no surprise—driven by technology advances and shifting customer ...

The Centers for Disease Control and Prevention’s (CDC’s) Immunization Safety Office (ISO) is responsible for studying vaccine risks once vaccines are administered to the public. ISO was already a ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s ...

There has recently been a proliferation of new quantitative tools as part of various initiatives to improve the monitoring of systemic risk. The "SysMo" project takes stock of the current toolkit used ...

On March 13, 2020, the Secretary of Health and Human Services (HHS) declared a nationwide public health emergency (PHE) due to the unfolding COVID pandemic (CDC, n.d.; NASEM, 2024). A key component of ...