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
Times are changing—and changing fast—in the world of digital technology. Businesses are trading outdated legacy processes for innovative digital transformation technology as their companies grow. According to one survey, 80 percent of business leaders are speeding up efforts to digitize work processes and implement new technologies. It’s no wonder businesses are making the shift with … 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
