Thought Leadership
Four Years In: What the EU Clinical Trial Regulation Has (and Hasn't) Delivered
CTIS is finally maturing, but staying on top of it is its own job. Between the new transparency framework, the COMBINE and FAST-EU pilots, and the Biotech Act on the horizon, the rules keep shifting. Read this blog to learn what's working, what isn't, and what sponsors...
IMP Labeling Workflows That Reduce Relabeling Risk and Start-Up Delays
Investigational medicinal product (IMP) labeling sits at the heart of clinical trial supply, impacting departments across pharmaceutical organizations, from clinical operations and regulatory affairs to quality assurance and beyond. When labeling activities are managed across...
Xtalks | EU Clinical Trial Regulation: Latest Developments and Upcoming Opportunities
The EU clinical trial landscape has changed significantly since Regulation (EU) No 536/2014 became applicable on January 31, 2022, and sponsors now need a clear view of how the framework is operating in practice and where it may evolve next. This webinar explores the current...
The Veeva Vault RIM Translation Integration Playbook
Managing multilingual regulatory submissions shouldn't mean chasing files across email threads and re-entering metadata by hand. This playbook breaks down how direct translation integration with Veeva Vault RIM eliminates manual bottlenecks, preserves compliance, and cuts...
Buyer's Guide: Translation Management Integration with Veeva Vault RIM
Translation bottlenecks, fragmented audit trails, and uncontrolled AI output aren't edge cases in regulatory operations; they're the predictable result of a poorly integrated workflow. This buyer's guide is built for regulatory leaders who need more than a file...
Potential Impact of the EU Biotech Act Proposal on Clinical Trial Activities
The European Commission's proposed Biotech Act takes direct aim at the operational challenges sponsors have faced since the EU Clinical Trial Regulation went live in 2022. Article 58 introduces targeted changes—including shorter assessment timelines, parallel submission of...
Metadata In, Metadata Out: Reducing RIM Submission Rework with In-System Translation
Regulatory teams managing global submissions often lose hours to metadata mismatches, version drift, and disconnected translation workflows. When files leave your RIM system, they take their submission context with them—creating reconciliation work that delays approvals. The...
Scaling Clinical and Regulatory Content with GlobalLink's Intelligent Performance
A Top 10 pharma needed to accelerate clinical and regulatory translations without increasing compliance risk or slowing submissions. This case study shows how they kept content inside Veeva Vault with an automated integration and a hybrid model (AI + validated translation memory ...
From Draft to Deployment: Creating Global-Ready Content from the Start
Clinical, regulatory, and commercial teams all rely on the same content, yet often work in siloes. This white paper examines the real cost of disconnected content strategies and why localization should be treated as a strategic input, not a final step. Discover how global-ready...
From Documents to Data: A New Paradigm for Pharma in the Age of AI
AI can’t deliver value if it’s fed a chaos buffet of PDFs, versions, and untagged content. This piece explains how pharma teams are shifting to structured, machine-ready data to actually use AI safely and effectively. Learn the pillars that make AI work in regulated environments....
Rewriting the Rules of Informed Consent Development with AI
ICF development is resource intensive and costly. Learn how forward-thinking teams are streamlining the process with powerful AI tools....
Could Data Standardizations be the Silver Bullet for Faster Electronic Clinical Outcome Assessment (eCOA) Deployment?
Choosing an electronic clinical outcome assessment (eCOA) provider is a complex process that involves a variety of different aspects including experience, scientific support and knowledge, integration capabilities, scalability, study-specific requirements, and so much more. ...
Accelerating Pharma Labeling with Intelligent, Compliant Content
Juggling multilingual labels across varying regions and products? Managing the updates and complying with local health authorities' requirements can be a challenge for global pharmaceutical companies, who are facing increasing pressure to streamline labelling processes and...
Health Canada's Transition to XML: What Regulatory Teams Need to Know
Health Canada’s shift to XML Product Monographs starts July 2025. Learn what regulatory and compliance teams need to do now to stay aligned and submission-ready....
AI in Clinical and Regulatory Content: Trends, Challenges, and Opportunities
During this webinar, we will unveil the results of our industry survey on the role of Artificial Intelligence (AI) in clinical and regulatory content. This session will explore how AI is being evaluated and applied to search, analyze, and generate clinical and regulatory content,...
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...