Thought Leadership

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...

Sponsor Strategy for Controlling Content and Language Complexity

Modern clinical trials span multiple sites and locations, requiring intense communication, documentation, and data management. As a result, many trial sites operate under a vast constellation of vendors to address patient, process, and regulatory needs, yet the external support...

The Ultimate Clinical Trial Translations Checklist

Clinical product development is an elaborate endeavor executed through a complex web of processes that are in large part accomplished through various document and communication work streams. These work streams can represent a significant source of cost, risk, and time. When a...

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...

Intelligent Automation for MDR & IVDR Content: Summary of Safety & Clinical Performance (SSCP), Summary of Performance (SSP), and Selected Labeling

Content requirements under the EU’s MDR and IVDR, including the translation of labeling, marketing, SSCPs, SSPs, and clinical communications, are set to dramatically increase. Currently, most device manufacturers use manual processes and document-based applications like Microsoft...

Panel: Deploying AI for Translation - Real Life Examples

Learn how leading companies deploy machine translation and the results they are seeing from their MT strategy. ...

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...

7 Considerations for Improving the App Localization Process

App localization can be a complex process, especially for life sciences organizations. With many apps designed with patient experience in mind, such as patient portals designed for the collection of health data and tracking patient journeys, it's critical that...

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...

Considerations and Opportunities in Capturing Oncology Patients’ PRO Data

There has been a historic lack of guidance in capturing patient data for oncology patients. Join Bill Byrom, VP and eCOA Scientist at Signant Health in conversation with Mark Wade, Global Practice Leader at TransPerfect, as they discuss: - The need for specificity of...

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,...

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...

Driving Digital Excellence: Delivering Seamless and Personalized Customer-Centric Experiences

The digital evolution in reaching and engaging with global communities, including sponsors, CROs, patients, and HCPs, has drastically shifted the way medical affairs teams connect with key stakeholders. As the industry pursues ways to improve a consumer and patient-centric...

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...

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...

A Checklist for eCOA Solution Deployment: Best Practices and Considerations

Selecting and deploying a new eCOA solution involves many important factors - from determining the capabilities of the Language Service Provider (LSP) to identifying the technology used for each COA migration - and it’s impossible not to worry about missing a key detail in the...

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...

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,...

Top 10 Biotechnology Company Captures and Disseminates Insights from a Key Advisory Board Meeting

The company enlisted the support of TransPerfect to provide a medical writer with expertise in the genetic disease to transcribe the meeting in full and produce an executive summary detailing the main takeaways and discussions....

Clinical Data Services Company Launches its Statistical Webinar Series

“Another great seminar in a long line of excellence. I can only say, keep it up!”...

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...

Global Pharma Saves $1.1M with Regulatory Translation Solution

AI-powered workflows to help reduce costs and timelines while being scalable to the large volume of content required....

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 gaps...

Content Automation to Meet MDR & IVDR Requirements

Marc Miller, President of TransPerfect's Medical Device Solutions chatted with experts from Takeda Pharmaceuticals & QServe to learn about MDR & IVDR labeling compliance while cutting risk, cost, & turnaround by using structured content, process automation, &...