In July 2020, the US Food and Drug Administration (FDA) published the draft guidance entitled Cannabis and Cannabis Derived Compounds: Quality Considerations for Clinical Research …

Patient enrolment is a pivotal aspect of any clinical trial. Without a large enough subject group, trial results may lack statistical significance as not enough …

The introduction of the General Data Protection Regulation (Regulation (EU) 2016/679) (“GDPR”) was a painful process for many companies as databases were stripped, new practices …

While more information needs to be learned about COVID-19, it has become clear that poorer outcomes and the risk of mortality in the US population …

Risk-based monitoring (RBM) may be a relatively recent phenomenon, but it has become a commonly used methodology in clinical trials as evidence of its benefits …

Clinical trials are a cornerstone of drug development, providing scientific evidence on the safety and efficacy of novel pharmaceutical compounds. While traditional trials have effectively …

Maintaining compliance can be a relentless drain on resources. Alternatively, business can make good use of the data collected for compliance to gain actionable business …

The global crisis caused by the coronavirus has disrupted our personal and professional lives in ways that seemed inconceivable only a fewmonths ago. This is …

A staggering number of clinical trials fail to meet recruitment goals, leading to delays, early termination, or inability to draw conclusions at trial completion due …

Working in the clinical trial space teaches you a lot about resilience, there is a sense of duty to get things done, and this intensifies, …