Thought Leadership
Webinar

EU CTR: An Introduction to European Clinical Trial Transparency

Are you looking to stay ahead of the curve in the ever-evolving landscape of European clinical trials? We are thrilled to announce the availability of our newest on-demand webinar, in which we dive deep into the recent changes to the European Clinical Trial Regulation (EU CTR)...
White Paper

EU CTR White Paper - Operational Considerations & Challenges

The Clinical Trial Regulation (EU) 536/2014 (CTR) came into effect on January 31, 2022, replacing the previous regulatory framework of the Clinical Trial Directive 2001/20/EC (CTD). This white paper provides an overview of the CTR and its impact on the organizational readiness...
Blog

The C3 Summit: Boston Recap

The second event in our series of C3 Summits took place in Boston on May 16, 2023. We invited industry experts and leaders to discuss challenges, opportunities, and strategies in clinical trial diversity, centricity, and outcome assessments through the lens of real-world...
Blog

The C3 Summit: San Francisco Recap

April 20 marked the first in our series of C3 Summits, which kicked off in San Francisco. Throughout the event, we invited industry experts to panel discussions to explore patient diversity, centricity, clinical technologies, and innovations. In this recap, we will...
Blog

The Quality Review of Documents (QRD) v9.0 for Veterinarians: A Step Toward Better Care

The Quality Review of Documents (QRD V9) update came into effect on January 28, 2022. The new version consists of a set of guidelines established by the European Medicines Agency (EMA) outlining the responsibilities and duties of those who ensure the quality of veterinary...
Blog

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 medicinal...
Blog

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...
Webinar

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...
Blog

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...
Blog

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...
Blog

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,...
Client Story

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....
Client Story

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!”...
Client Story

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....
Blog

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...
Webinar

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, &...
Client Story

Leading Japanese Pharma Company Authors High-Quality Regulatory Documentation

TransPerfect provided medical writing support with subject matter expertise and key regulatory experience to produce high-quality ICFs and a protocol....
Client Story

Medical Writing Services Increase Patient Comprehension

“The informed consent form and companion piece were super! Overall, the feed back we received from our patient advocacy panel was great and they found the content useful, clear, and relevant.”...
Client Story

Sanofi - The Clinical Translation Centralization Journey in Light of the EUCTR 536/2014

Sanofi centralizes clinical trial translations through GlobalLink and best-in-class AI, MT, and more. ...
Client Story

Deploying GlobalLink for Global Clinical Studies: Merck/MSD Case Study

Learn how GlobalLink can accelerate the launch of global content. ...
Client Story

Rapidly Bringing HCP Support Tools to Global Markets at Scale

GlobalLinks helps AstraZeneca launch HCP tools around the world. ...
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,...
Client Story

UBC Case Study: UBC Expedites Administration and Contact Center Response Times

TransPerfect Connect helps UBC expedite administration and call center response times....
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...