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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...
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Where to Apply Machine Translation in Life Sciences Content Workstreams Right Now

In the life sciences industry, it’s increasingly essential to reduce cycle times and enhance operational efficiencies, especially across clinical and commercial team processes. To address evolving regulations from global health authorities and the common pain points of costs,...
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The Imperative of Accurate Translations in Clinical Research

With the increase of global clinical trials, clinical documentation is required to be accurately translated at every stage from lab to launch. Despite the administrative burdens and tight regulatory timelines that clinical teams face, accuracy cannot be sacrificed in life science...
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5 Essential Use Cases for Generative AI and Machine Translation in Regulatory Content Submissions

Moving a drug from development, through clinical trials, to eventually the market involves many critical content pieces and challenges along the way.   According to research commissioned by Genpact, 72% of senior executives across the life sciences industry cited regulatory...
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Selecting an eCOA Vendor to Best Fit Localization Needs

One of the main challenges for pharma/biotech companies regarding clinical trials is prolonged eCOA study start-up.  It is paramount to choose the right eCOA platform for each study. Sponsors must consider the study’s specific needs, such as user-friendliness, compliance,...
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Clinical Outcomes Assessments (COAs) in Clinical Trials: Copyright and Licensing

Author: Maria Arnott and Corinne Shoch, COA/eCOA Licensing Management Team In clinical trials, it is usually necessary for sponsors to obtain permission to use copyrighted materials, such as clinical outcome assessments (COAs). The process to obtain these permissions is called...
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How to Approach the Protection of Personal Data and Commercially Confidential Information of EU Clinical Trial Applications: Practical Considerations

Authored by Pierre-Frédéric Omnes, Executive Director The publication of clinical data has been a focus of public policies and regulations in the European Union (EU) in recent years to avoid duplication of clinical trials, foster innovation, and encourage the development of new...
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Localizing Platforms for Digital Health: The Importance of Post-Localization Context Review

In a landscape defined by continuous technological advancement, many organizations in the life sciences industry strive to increase audience engagement through digital modalities, such as mobile and web applications or web portals. Building a robust technological infrastructure...
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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...
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ICH E6(R3): Understanding the Updated Good Clinical Practice Guidelines (GCP) and Their Future Impact

The International Council for Harmonization (ICH) announced revisions to its Good Clinical Practice (GCP) guidelines, marking a significant move towards more closely aligning clinical practice with the rapidly evolving technological landscape.   The purpose of the ICH...
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Anticipate Your Language Needs: The Ultimate Clinical Trial Translations Checklist

“Content is king” is cliché marketing jargon, but in clinical product development, the cliché holds true. Clinical product development is an elaborate endeavor executed through a complex web of processes that are in large part accomplished through various document and...
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IMP Labeling: EU CTR Transition Considerations

The European Union Clinical Trial Regulation (EU CTR) went live on January 31, 2022. The first-year transition period ended on January 30, 2023, so using the Clinical Trial Information System (CTIS) is now mandatory for all initial submissions of interventional clinical trials...
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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 function...
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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 digitization...
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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,...
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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...
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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 include...
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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 on...
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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...
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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, or...
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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,...
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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 and...
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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...
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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. Due to...