Resource

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) and how they impact the world of clinical research. Access this webinar and gain invaluable insights on: 1) Overview of the new EU CTR: Understand the latest regulations governing clinical...

Resource

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 and operational execution of clinical trials in the European Union (EU) and European Economic Area (EEA) Member States. Discover the main features of the CTR, including the use of the "Regulation...

Resource

Beyond Borders: Navigating the Complexities of Omnichannel Content Strategy for Global and Local Markets

Hosted by Christine Buggle, Senior Director at TransPerfect Life Sciences, in discussion with Ewelina Knigawka, Executive Director of Content and Partnership Excellence at Novartis, and Scott Dille, Digital Content Lead at Novo Nordisk, this session outlined key considerations when implementing a successful global to local omnichannel strategy. Additional topics in the conversation included: - Establishing a global governance structure for omnichannel: Ensuring a...

Resource

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 more insight without spending money or engaging in direct sales conversations, this is a great way to explore some of your most pressing questions....

Resource

Pfizer x Partner4Better Spotlight

TransPerfect supports the development of the Global Learning Program: Partner4Better, by delivering relevant educational content to a global audience in diverse languages....

Resource

MedTech Summit EU 2024 | What's Past is Prologue: Evolution (and Future) of AI and Content Automation

Content automation technologies have been developing for 70 years – MDR and IVDR have accelerated this development, as well as adoption across the device industry. And, while product-related applications for artificial intelligence (AI) generate attention-grabbing headlines, the larger (and more certain) financial benefits are in process-related applications. So the question remains: How are translation AI and process automation software (CCMS, TMS) converging to automate...

Resource

Human & Animal Blood Cell Image Annotation Spotlight

An award-winning healthcare AI company specializing in using the best in human and computational intelligence approached DataForce to build an external team with a background in biology to review and annotate thousands of microscopic images of blood smear samples. With 30,000 images across six species, our client was looking to deliver precise and individualized healthcare while also ridding the world of preventable diseases through rapid at-home testing for immune health. To...

Resource

Pragmatic Use Cases for AI in Pharmacovigilance and Safety

The rapid rise of artificial intelligence presents an opportunity for effective and transformative applications in pharmacovigilance. Intake, query routing and response, case reporting, HAQs, and more are now extremely feasible use cases that create exponential efficiency in reducing costs, administrative burden, and timelines while increasing quality and, most importantly, improving safety....

Resource

eCOA Vendor Localization Best Practices Checklist

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, and configurability. The investment of both time and money, not to mention protecting and upholding the integrity of the data collected, is critical when seeking regulatory approval and confirming drug...

Resource

LifeSci Talks COA Series | Exploring the Intersection of Clinical Practice and Entrepreneurship: Technological Innovation in Clinical Research

In this episode of TransPerfect LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Dr Michelle Longmire, CEO of Medable, to discuss her journey from clinical practice to entrepreneurship, driven by a passion for rare disease, and the need for technological innovation in clinical research. The conversation highlights key challenges faced in transitioning from academia to entrepreneurship, and the importance of storytelling in...

Resource

6 Pathways to Take Your MT Strategy to the Next Level in 2024

With 2024 well underway, innovators in the global life sciences and pharmaceutical industries continue to question how to maximize efficiencies and reduce complexities in clinical and regulatory content development and localization. As part of the broader technological roadmap, AI and automation remain front and center as key players in taking these workflows to new heights. Machine translation (MT) is expected to directly impact and transform approaches to multilingual...

Resource

An Overview of Generative AI and Machine Translation for Life Sciences

Global life sciences companies are realizing the potential artificial intelligence (AI) and machine learning (ML) has to drive efficiency in content and translation management. To capitalize on this, organizations need to identify the right solutions. Discover important considerations for integrating AI and ML into translation management strategies, steps to get started, and a practical use case in this overview....

Resource

Multilingual Labeling: Considerations for Efficient, Cost Effective and Compliance Labeling

Accurate and compliant labeling of an investigational medicinal product (IMP) is an important and integral part of clinical trial operations. A misstep in labeling can lead to significant delays, affecting the entire study’s timeline and potentially incurring costs ranging from $100,000 to $700,000 in hard expenses. In worst-case scenarios, incorrect labeling might necessitate a complete product reproduction. Learn more about the strategies and solutions leading sponsors are...

Resource

COA White Paper | The Tale of Two Trials

In “The Tale of Two Trials,” Mark Wade takes an in-depth look at the benefits and drawbacks of the traditional, paper-based outcomes assessment method, as well as the advantages of the emerging electronic clinical outcomes assessment (eCOA) solutions. With each having the potential to affect data quality, timelines, and overall trial cost, the choice between them is a much discussed topic....

Resource

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 more insight without spending money or engaging in direct sales conversations, this is a great way to explore some of your most pressing questions....

Resource

GL - Machine Translation Success in Life Sciences

From clinical trial documentation to patient communications and to post-market materials, machine translation (MT) enables fast, and cost efficient communication in various languages worldwide. This guide shares case studies of impactful AI and MT implementations for leading pharmaceutical, biotech, and medical device companies. Download now to see how your life sciences peers reduce translation cycle times, increase speed of global communications by 75%, and more. ...

Resource

Generative AI in Life Sciences Industry: Ethics, Applications, and Transformations

Discover the role of generative artificial intelligence (GenAI) in life sciences, including what is merely a trend vs. what is truly transformative. The speakers will explore pragmatic applications, ethical considerations and the potential future role of generative AI in life sciences, research and development (R&D) and product development. The discussion will provide valuable insights into the ongoing AI revolution within the life sciences sector, including practical...

Resource

Strategic Artificial Intelligence (AI) Implementation for Medical Device Companies

Medical device companies are leveraging artificial intelligence and machine learning to streamline regulated medical device content work streams, including labeling, marketing, and PMS reporting. Learn about implementing a strategic AI program and discover how top medical device companies save time and cut costs with AI-powered translation and localization in this guide. ...

Resource

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 compliance. In this webinar featuring TransPerfect Life Sciences Executive Director Pierre-Frederic Omnes, we explore topics surrounding trial transitions, and answer common questions including: • Which...

Resource

LifeSci Talks COA Series | The Future of Capturing Patient Data in Clinical Trials: DCTs, Site Staff Burden, and Regulation Considerations with Paul O'Donohoe

Mark Wade interviews Paul O'Donohoe, Senior Director of Product for eCOA and COA at Medidata. They delve into the challenges and opportunities of adopting decentralized clinical trials (DCTs) and explore topics such as mixed modalities for data capture, patient burden, site-centricity, HTML5-based app wrappers, regulatory advancements during the pandemic, and the importance of flexibility in clinical trial technology adoption....