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....
Where to Apply Machine Translation in Life Sciences Content Workstreams Right Now
Discover how using AI-powered machine translation (MT) workflows can have a transformative impact on ensuring that the hundreds of different kinds of documents involved in medical product development and launch meet global language requirements. Explore three immediate use cases...
The Imperative of Accurate Translations in Clinical Research
Discover the imperative of accurate translations in clinical research. Consider the risks and understand the severity of impact when clinical research documents are translated inaccurately. Trust TransPerfect Life Sciences for support in anticipating language needs proactively...
How Pharmacovigilance Automation Solutions Can Help You Meet Tight Regulatory Reporting Timelines
Discover how pharmacovigilance teams can use automation solutions to meet tight regulatory timelines. Learn five solutions that the right pharmacovigilance automation software can offer PV teams. Trust TransPerfect Life Sciences for automated pharmacovigilance and drug safety...
How to Improve the Speed and Accuracy of Patient Communications in Clinical Development
Discover how clinical research teams can improve the speed and accuracy of patient communications in clinical development. Learn the top three use cases for GenAI and MT to improve speed and accuracy, including automated clinical content creation, localization and personalization...
Implications of AI in Healthcare and Life Sciences: Ethical Considerations in the Age of AI
Discover and better understand the nuances of artificial intelligence (AI) in the life sciences industry. Examine three of the most significant ethical considerations for AI in healthcare, including Data Privacy & Security, Bias and Fairness, and Transparency and...
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...
3 Ways to Leverage Generative AI in Pharmacovigilance
Discover how clinical and regulatory teams can leverage AI-powered workflows, generative artificial intelligence (GenAI), and machine translation in PV processes and documentation. Learn the top three use cases for AI-powered workflows in PV & safety, including safety intake...
How to Select the Right Regulatory Writing Company for Your Organization's Needs
Discover how clinical and regulatory teams can select the right regulatory writing and consulting company to fit their organization's needs. Learn the top five considerations when selecting the right regulatory writing and consulting company, including expertise and...
5 Essential Use Cases for Generative AI and Machine Translation in Regulatory Content Submissions
Discover how clinical and regulatory teams can mitigate risk, maintain compliance, reduce administrative timelines, and save on costs by leveraging the transformative power of generative artificial intelligence (GenAI) and machine translation workflows. Learn the five significant...
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...
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 ...
How to Approach the Protection of Personal Data and Commercially Confidential Information of EU Clinical Trial Applications: Practical Considerations
In this piece, we'll explore the two primary frameworks that are driving EU CTR transparency efforts: the European Medicines Agency’s Policy 70 and Regulation (EU) No. 536/2014 on clinical trials. Gain valuable insight into requirements, exceptions, and implications for all...
Unlocking the Power of AI and Machine Learning in Life Sciences
Life sciences companies are putting artificial intelligence (AI) and machine learning (ML) into practice, realizing its potential to revolutionize adverse event detection, diagnostics, and more. For AI and ML to be truly effective, you need to give context to your data, teaching...
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...
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 and regulatory landscape. What are the key...
LMS: A Must For Study Compliance And Efficiency
Life Sciences organizations function in a heavily regulated global environment, as such, have strict training requirements when it comes to investigative site staff and vendors with involvement in a study protocol. This training is necessary not only to minimize the risk of...
MDR and IVDR Timeline Overview
In order to take advantage of the MDD extension, device manufacturers must comply with several near-term deadlines and plan for long regulatory turnarounds – the extension provides less time than you might think! Learn how TransPerfect can help you meet the impending MDR and IVDR...
Health Canada's XML Mandate: Pioneering the Future of Pharmaceutical Content
Discover how Health Canada's transition to XML-based templates is reshaping Canadian healthcare content management. Learn about the benefits of XML formats, phases of implementation, and the transformative potential for pharmaceutical companies. TransPerfect Life Sciences...
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...
Navigating the Regulatory Landscape for Expanded Access Programs
Preview: Discover the world of expanded access programs (EAPs) and the dynamic regulatory environment they operate in. In this blog, we delve into the significance of EAPs, the evolving global regulations governing them, and the vital role they play in providing timely treatment...