Is your organization ready for the upcoming regulatory changes affecting medical devices and clinical trials in the European Union (EU) and the United States (U.S.)? Both the EU and the U.S. have recently started implementing new rules to make clinical trials more accessible, transparent and diverse. The EU is also putting into place rules for … Continued
As we reach the end of the public health emergency in the United States, healthcare professionals will revert to addressing healthcare issues such as non-communicable diseases (NCDs). At-home diagnostic manufacturers including ThermoFisher, Quidel, and Danaher are bracing for a drop in demand for at-home COVID tests by shifting their focus to help patients prevent and … Continued
As seen in HEALTHCARE BUSINESS TODAY https://www.healthcarebusinesstoday.com/improving-communication-with-diverse-participant-populations-in-clinical-trials/ The recent push to develop COVID-19 vaccines as quickly as possible revealed the continuing need to include diverse populations in all clinical trials. Without full representation, confidence in science and the healthcare system can take a hit. Planning for richly diverse enrollment starts early in the process with … Continued
In April 2022, the U.S Food and Drug Administration (FDA) released guidance requiring sponsors to create diversity plans to improve enrollment of underrepresented populations in clinical trials. Although the guidance is clear and comprehensive, the path forward is not. On paper, the diversity plan looks ambitious but achievable. In the real world, however, reaching enrollment … Continued
How can life sciences companies ensure that they are providing accurate, efficient, reputable translations for the communities they support? The key is to engage a language solutions partner with the proven industry knowledge and linguistic expertise needed to meet the stringent requirements of their global content. Translation Challenges: Medical Devices For medical device companies, translation … Continued
At long last, the European Union (EU) Clinical Trials Information System (CTIS) is ready for action. That means that on January 31, 2022, EU Regulation 536 goes into effect. Although there is a one-year transition period for sponsors conducting new clinical trials, forward-thinking companies should seek to meet the new requirements sooner rather than later. … Continued
