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MDR Date of Application is STILL May 26, 2021 – Are You Prepared for Language Compliance?

After entering into force on May 25, 2017, the European Union (EU) Medical Device Regulation (MDR) EU 2017/745 will be applied to all Member States from May 26, 2021, after a one-year extension due to the ongoing pandemic. In a previous blog post, we discussed the key aspects of the regulation, namely the stricter regulatory […]

Tackling Covid-19 Vaccine Hesitancy in Limited English Proficient Communities: Lessons From the Flu Shot.

2020 was an unprecedented year of innovation in healthcare. The Covid-19 pandemic led to numerous scientific advances in diagnostics, treatments and vaccines to combat the SARS-CoV2 coronavirus. But developing vaccines is just one part of the effort to end the pandemic, encouraging people to take them is another challenge. Previous widespread vaccination campaigns, such as […]

Why Linguistic Validation is Crucial To Ensuring eCOA is Culturally and Conceptually Equivalent

Over the last 20 years, the worldwide number of clinical trials has increased exponentially. Clinical trials also become more complex, with the adoption of multi-center, international interventions becoming the norm. This means that the pharmaceutical industry is confronted with the exponential growth in costs associated with running such clinical trials, with each molecule requiring approximately […]

Cultural Relevance in Medical Adherence: Pre, During and Post Pandemic

In the US, medical non-adherence accounts for 30-50% percent of chronic disease treatment failures and close to 125,000 preventable deaths each year, representing losses of $637 billion for the pharmaceutical industry. The COVID-19 pandemic has created additional strain as healthcare utilization dropped significantly .  82% of healthcare providers surveyed indicated a significant decline in appointments […]

Driving Diversity in Clinical Trials

A recent article published by Clinical Leader illustrates the importance of making information about clinical trial participation accessible to those who are currently under-represented in pharmaceutical research. The findings concluded that understanding where minority groups are currently going to find further information is a good start to bridging the existing disparities in Clinical Research by […]

New European Union regulations for medical devices and in vitro devices — Are you ready to thrive in the new landscape?

On May 26th, 2020, the new Medical Devices Regulation (MDR) will be fully enforced and applied to the approximately 500,000 medical devices being sold in the EU. Soon after the MDR comes into full force, the In Vitro Devices Regulation (IVDR) will also replace the old directive, in May 2022. These new regulations put a […]