Thought Leadership
Blog

Leveraging Artificial Intelligence (AI) in Pharmacovigilance

Expert-driven technologies are continually being implemented into the clinical process to eliminate manual burdens and ramp up efficiencies. AI-enabled automated systems help to remove the barriers that prevent high-quality data and compliance in reporting of clinical events....
Blog

A Comparison Between Document Management Systems (DMS) and Component Content Management Systems (CCMS) for Pharma

CHOOSING THE RIGHT OPTION FOR YOU AND YOUR BUSINESS NEEDS Global pharma companies produce and manage a lot of content that is complexly intertwined. To mitigate risk, ensure patient safety, meet regulatory compliance standards, and reduce cycle times for faster drug-to...
Blog

Is Your Clinical Supply Strategy Ready for EU CTR?

The content in this blog is outdated. For the most recent information on EU CTR, see our latest blog here.   OUTLINING IMP LABELLING CHANGES AND THEIR IMPLICATIONS In May 2014, the European Union Clinical Trial Regulation (EU CTR) No. 536/2014 was passed,...
Blog

An Unlikely Perfect Pairing: Life Sciences & Translation

What Is Life Sciences Translation? Let’s first define the term “translation” within a life sciences context. Life sciences translation is the adaptation of clinical documentation and MedTech materials across different languages. While the concept may seem relatively simple, it...
Blog

The Importance of Over-the-Phone Interpretation for Emergency Services

Imagine calling 911 in a state of crisis at the scene of an emergency situation, only to hear the call handler trying to understand you. And there’s nothing wrong with the connection—the poor communication is only because the person doesn’t speak your language.This kind of...
Blog

Does a One-Stop-Shop Global Translation Provider Truly Exist?

Within the global translation market, there are over 200 global language service providers (LSPs), each reporting annual revenues larger than $1 million. Collectively, the 2020 revenue of all 200 companies equates to approximately $8 billion. All of these LSPs have...
Blog

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...
Blog

3 Translation Methodologies for Life Sciences Documentation

Translation is a complex endeavor, particularly in life sciences. Translation workflows, from receiving the document to delivering the final product, have multiple steps that must be followed with utmost accuracy.There is no one-size-fits-all model when translating clinical...
Blog

Preparing Compliant eCTD Submissions in Asia

In May 2015, the US FDA published final and binding guidance requiring submission within 24 months of certain Common Technical Documents (CTDs) in an electronic format. This was ratified in 2017 and subsequently revised in February 2020 (Rev. 7). Currently, other notifying bodies...
Blog

Preparing and Publishing a Scientific Manuscript

If you’re preparing to write a scientific report for a peer-reviewed journal, it’s critical to have a detailed plan before beginning the first draft of your manuscript. Following the correct format and general guidance for manuscript writing is a good start, but there...
Blog

The Summary of Safety and Clinical Performance (SSCP) for Healthcare Professionals and Patients

In 2017, the European Parliament and the Council of the European Union (EU) set a regulatory upgrade on medical devices to strengthen governance structure. This regulation update includes increased oversight of notified bodies, new requirements for transparency and traceability,...