Thought Leadership

Transcreation in Clinical Research: How to Use Transcreation and Localization to Resonate with Your Audience

Clinical teams need to communicate with multilingual audiences across the globe while also meeting strict regulatory requirements. In addition to helping teams remain compliant, accurate translations ensure the highest standards of patient safety are met across clinical...

How Pharmacovigilance Automation Solutions Can Help You Meet Tight Regulatory Reporting Timelines

Pharmacovigilance (PV) teams play a critical role in detecting, assessing, understanding, and preventing the unintended adverse effects of medications and treatments. Their work, which includes drug reaction monitoring, drug safety surveillance, side effect monitoring,...

How to Improve the Speed and Accuracy of Patient Communications in Clinical Development

According to Phesi, more than a quarter of clinical trials conducted in 2023 were canceled during Phase II.  As clinical research teams struggle with patient recruitment and engagement under tight deadlines and immense regulatory pressure, patients also grapple with...

3 Ways to Leverage Generative AI in Pharmacovigilance

Despite the rigorous drug safety and efficacy standards in trials, study medicines can have unintended side effects on patients throughout the clinical trial journey and even in the post-market setting. To ensure patient safety and mitigate risk, global health regulatory...

How to Select the Right Regulatory Writing Company for Your Organization's Needs

In a landscape defined by ever-evolving global guidelines from health authorities, many life sciences organizations’ clinical and regulatory teams face challenges in navigating the regulatory affairs writing and document submission process. Adhering to strict rules while...

4 Immediate Applications for AI Translation in Pharma

Precision and speed are key facets of success in the dynamic world of pharmaceutical development. To achieve these goals, AI-powered capabilities, such as machine translation (MT), can have a considerable and transformative impact.  Automated translation workstreams enable...

Five Essential Roles Artificial Intelligence Plays in Medical Writing

In the biotech and pharmaceutical industries, the importance of effective communication cannot be overstated. With a responsibility to accurately convey critical scientific findings, regulatory updates, and patient information1, the pressure is on medical writing teams to develop...

How Medical Writing Can Drive Patient Engagement

Medical writing is a critical component of the broader patient engagement landscape, establishing the foundations of communication between pharmaceutical companies and patients. The quality of medical communication can be transformational in how a patient engages with and...

Lay Summary Development: The Oregon Trail of Regulatory Writing

The Oregon Trail: one of the most iconic and cherished computer games of all time, filled with boxy graphics, heartache, and the occasional bout of dysentery. Players took on the role of wagon party leader, navigating the unchartered frontier of the Wild West in 1848—all the way...