Hearing the Patient Voice Through Technology and eCOA

The intrinsic value of the patient’s voice has been heard. Over the past few years, Notifying Bodies have been ‘vocal’ on their desire for Studies to be more patient centric and diverse. Clinical Outcomes Assessments (COAs), a scientific instrument/measure whose primary...

3 Benefits of Centralizing Global Content Solutions for Regulatory Teams

The regulatory landscape is continually evolving, prompting pharmaceutical companies to adjust their strategies to remain in compliance with existing requirements. Since the remote shift throughout the COVID-19 pandemic, regulatory teams have been gradually embracing...

Assessing Readiness for EU Clinical Trials Regulation (CTR): Five Points to Consider

The EU Clinical Trials Regulation (EU CTR) became live on January 31, 2022. The first-year transition period ends on January 30, 2023, so from January 31, 2023, onward, EU CTR is mandatory for any initial submission of interventional clinical trials with investigational...

Investigational Medicinal Products: Labeling Changes and Their Implications

This information has been updated based on a previous blog we published in 2021.   In May 2014, European Union Clinical Trial Regulation (EU CTR) No. 536/2014 was passed, replacing EU Directive No. 2001/20/EC to enhance clinical trial safety, efficiency,...

3 Automation Outcomes for Pharmacovigilance and Safety Teams

With the continued implementation of artificial intelligence (AI) and automated systems into the clinical process, automated data management systems have helped to alleviate manual burdens on safety teams to focus on more critical tasks. The goal at present is to enhance data...

Benefits of Electronic Labels: Investigational Medicinal Products

When a new therapeutic drug, medical device, vaccine, or other investigational medicinal product (IMP) is developed, a label must be on its packaging that provides relevant and important information, regardless of the country in which it is developed. Types of information...

Decentralized Clinical Trials | TransPerfect Life Sciences

This is the second of a two-part series on our recent C3 Summits TransPerfect Life Sciences held C3 Summits in Princeton, NJ; Raleigh, NC; and London, England, where multiple subject matter experts came together to discuss clinical content. Throughout these events, we focused...

Lack of Diversity in Clinical Trials: A Conversation

Conversations on Clinical Content (C3) Summit Debrief: Diversity in Clinical Trials This is the first of a two-part series on our recent C3 Summits During the 2022 C3 Summits held in Princeton, NJ; Raleigh, NC; and London, England; TransPerfect Life Sciences was delighted to...

Plain Language Summary Requirements for Clinical Trials

Plain language summaries (PLS) of Clinical Trial Results are a critical tool in medical communication to help disseminate summarized, easy-to-digest research information to general audiences. Typically, these are used to share details of clinical study protocols, publications...

Reaching Diverse Patient Populations to Drive Inclusivity in Trials

The COVID-19 pandemic was catalytic in highlighting gaps in health outcomes across the globe, with global health inequity disproportionately impacting minorities and communities of color.With a litany of factors influencing individual patient outcomes and access to healthcare...

Intellectual Property (IP) Strategies to Consider for Life Sciences Start-Ups

Intellectual property (IP) is one of the most valuable assets a life sciences innovator or start-up has. While these companies are often built on the foundations of successful pre-clinical studies, they face a substantial amount of time between obtaining regulatory approvals...

Connecting with Diverse Patients: How Call Centers Can Improve Patient Recruitment and Retention

Do you recruit patients for clinical trials? If the answer is yes, then how do you reach potential participants? Through emails? Ads on the radio? Do you call someone and see if they are interested? There are many different ways patients are recruited for clinical trials: in...

Electronic Product Information – Everything You Need to Know

One of the latest initiatives being spearheaded by EMA is publishing ePI, or electronic product information. In some respects, the pharma industry has lagged behind other major industries in terms of how documentation and critical information is relayed to the end patient....

3 Benefits of Centralizing Global Content for eCOA Migration

In recent years, life sciences organizations have been looking for a standardized approach to collecting global patient data while maintaining compliance and adhering to study timeline milestones. For clinical trials launched across multiple regions, time zones, and patient...

Pharma Digital Marketing: Trends for Customer Engagement

Trends for Pharma Digital Marketing All you need to know about above-the-line and below-the-line advertising and multichannel and omnichannel engagementIn today’s evolving digital landscape, companies are looking for the best ways to improve customer experience and...

Why Automate the Literature Monitoring Process?

A key concern for pharma companies is keeping a close eye on publications that might mention their product and its potential impact on the public. These publications can be extremely dense in volume, commanding careful review of multiple documents across several different...

Driving Patient Engagement in Medicine Development and Decision-Making – Challenges and Opportunities

The need for integrating patient engagement strategies early in the medicine development process has sparked widespread discussion in the pharmaceutical industry and beyond. This shift toward patient-centric, patient-empowered healthcare and decision-making has highlighted...

Leveraging the Patent Priority Date: A Life Sciences Focus

The ACC last month hosted the San Francisco Bay Area Life Sciences CLE Conference, giving TransPerfect Legal Solutions (TLS) team members the opportunity to learn and connect with colleagues. One of the panels, moderated by Alex Trimble, Partner at Mintz Levin, Cohn, Ferris,...

Digital Health’s Role in Improving Patient Engagement

​ In recent years, the patient journey has become more virtual, with patients seeking online information prior to engaging with healthcare providers (HCPs). Even as we transition back into traditional, in-person patient care, digital health is proving to be much more than...

4 Ways a CCMS Can Help Medical Affairs Achieve Global Content Reuse and Omnichannel Delivery

The medical affairs industry is undergoing a widespread digital transformation in the new era of patient centricity. Pharma companies must adapt their delivery of important medical information, such as patient outcomes, to effectively reach relevant stakeholders if they want...

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....

What’s Trending: Milestone Disputes in Life Sciences Litigation

Earlier this month, the ACC hosted an illuminating panel presentation on Life Sciences Litigation: A Look at Milestone Disputes & Recent Trends. Panelists included Lauri Mims and Jennifer Huber, both Partners at Keker Van Nest & Peters, and Ann Byers, Director, Shareholder...

The Evolving Machine Translation and Translation Memory Landscape for Life Sciences

Over the past 70+ years and to this day, translation technology has changed drastically as more companies are focusing on ways to improve their tech performance with data that is higher quality and customizable. Consequently, life sciences organizations have been...

Celebrating Women’s History Month with the Women of TransPerfect Life Sciences

March is Women’s History Month, and this year we wanted to take a moment to shine a spotlight on some of the hardworking women who make TransPerfect Life Sciences tick.Women have been historically underrepresented across STEM industries. In fact, according to the US...

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...

Your Treatment Plan for Curing the App Localization Headache

If translation had a prefrontal cortex, in-country review would create quite the headache.  This is particularly true for app localization. App localization is the process of adapting apps and their content to another language in a conceptually equivalent and culturally...

TransPerfect Life Sciences Director Anne Rhea Selected as VP of HBA’s Paris Chapter

The life sciences industry has historically been a male-dominated field, with women being underrepresented or undervalued. In fact, according to BioSpace’s U.S. Life Sciences 2020 Diversity & Inclusion Report, there were large gaps between women and men in life...

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,...

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,...

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...