Thought Leadership
Clinical Evidence in Digital Health: Considerations for Multi-Country Evidence Generation
The global adoption of digital health solutions has revolutionized healthcare delivery, offering unprecedented opportunities for innovation in patient care, diagnostics, and disease management. However, the generation of robust clinical evidence to support these technologies...
AI and MT for Regulatory and Clinical Content Office Hours - 10/9/24
TransPerfect's experts gather to answer questions from global pharma, biotech, and medical device leaders regarding AI and MT use cases, challenges, opportunities, best practices, and more....
AI and MT for PV and Safety Office Hours - 6/12/24
Welcome to TransPerfect Life Sciences' AI and MT Ask an Expert Office Hours. In these sessions, we provide an opportunity for our community to submit their pressing questions for our experts to answer live, in the company of your industry peers. If you are looking for some...
AI and MT for Regulatory and Clinical Content Office Hours - 5/15/24
Welcome to TransPerfect Life Sciences' AI and MT Ask an Expert Office Hours. In these sessions, we provide an opportunity for our community to submit their pressing questions for our experts to answer live, in the company of your industry peers. If you are looking for some...
Transitioning Clinical Trials Under the EU CTR
The transition from Clinical Trial Directive to Clinical Trial Regulation in Europe adds new requirements and complexities to the clinical development landscape. The required transition of all trials concluding January 1st, 2025 brings about several considerations to ensure...
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)...
Navigating the EU Clinical Trial Regulation Complexities - Current Challenges and Opportunities
As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the European Union Clinical Trial Regulation 536/2014 (EU CTR) went live on January 31, 2022. The first-year transition period has now ended, and from January 31, 2023, EU...
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...
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, &...
Content Solutions for MDR & IVDR Readiness
The implementation dates for MDR (May, 2021) and IVDR (May, 2022) are fast approaching and non-compliant manufacturers are putting their EU market access at risk. These new regulatory requirements have created a “tsunami” of increased content requirements—especially in critical...
Part 4: Clinical Trials and COVID-19: Remote Investigator Meetings
The novel COVID-19 virus has forced a lot of rapid changes in a very short period. Personally and professionally, we are all learning how to adapt. While restrictions on our day-to-day lives impact where, why, and how we interact, we still can come together as a community to...
Part 3: Clinical Trials and COVID-19 Adapting to Rapid Change
The novel COVID-19 virus has forced a lot of rapid change in a very short period of time. Personally and professionally, we are all learning how to adapt. While restrictions on our day-today lives impact where, why, and how we interact, we still can come together as a community...
Part 2: Clinical Trials and COVID-19 Converting to Remote Trial Management – How to Get Started
The novel COVID-19 virus has forced a lot of rapid changes in a very short period. Personally and professionally, we are all learning how to adapt. While restrictions on our day-to-day lives impact where, why, and how we interact, we still can come together as a community to...
Part 1: Clinical Trials and COVID-19: Situation now, its challenges, and the future
The novel COVID-19 virus has forced a lot of rapid changes in a very short period. Personally and professionally, we are all learning how to adapt. While restrictions on our day-to-day lives impact where, why, and how we interact, we still can come together as a community to...
Simplifying Clinical Trial Training Management
Training is important and required to remain current with appropiate regulations. This is key to protecting patient safety and putting out quality products....