Thought Leadership
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...
The Missing Link: Why Study Design Makes or Breaks a Clinical Trial
In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Farrell Healion, Founder and Principal Consultant at OptiTrial, to explore why study design is so often the overlooked "missing link" in clinical...
Considerations for eCOA in Global Clinical Trials
Regulatory submissions for eCOA in clinical trials can be tricky to navigat,e particularly when they stretch across various regions and languages. Requirements vary by country, guidance is open to interpretation, and one-size-fits-all strategies often create unnecessary delays in...
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...
Veeva RIM TMS Integration Checklist
If your regulatory team is still downloading documents from Veeva Vault, managing translation requests by email, or tracking submissions in spreadsheets, there's a better way. Reduce complexity, close compliance gaps, and shorten your submission cycle times with this...
The Current State of AI in Translation for Clinical Content
AI is reshaping how clinical trial content gets translated and localized, but in a regulated environment, speed can't come at the cost of accuracy or traceability. This white paper breaks down where AI delivers real value, where human oversight remains essential, and how to...
The Veeva Vault RIM Translation Integration
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...
LifeSci Talks COA Series | Are We Sacrificing Good for Perfect in Clinical Outcome Assessment?
In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Stacie Hudgens, Chief Scientific and Strategy Officer at Clinical Outcome Solutions, to discuss whether the field of clinical outcome assessment has started...
AI Governance in Medical Information: What "Human-in-the-Loop" Actually Requires
"Human-in-the-loop" has become the default reassurance in AI governance conversations, but most organizations are confusing having a human somewhere in the process with actually having control over it. In regulated environments like medical information, where AI errors...
C3 Summit 2025 - London
Conversations on Clinical Content, C3 Summit is part of a series of events hosted by TransPerfect Life Sciences featuring sessions with expert panels discussing present challenges, strategies, and innovations, as well as insights into future advancements, from R&D to...
Libraries in Clinical Outcome Assessments: How Valuable Are They—and Are They the Panacea They’re Claimed to Be?
Speed, cost, and quality are competing priorities in eCOA localization. Discover why translation libraries alone aren't enough, and what combination of proactive licensing, automation, and integrated technology can transform your deployment timelines....
From Reactive to Strategic: How AI Is Transforming Medical Information Contact Centers
Medical Information contact centers are under more pressure than ever; more channels, more complex products, more regulatory obligations. This blog explores how AI and digital tools can help MI teams meet rising demands without losing the human touch that defines exceptional...
Is AI Ready to Transform COA Development?
Can AI fully transform COA development and translation today? Learn from Mark Wade and XTalks....
Five Domains the FDA Wants You to Measure in PROs for Cancer—and Why Translation Affects All of Them
In cancer trials, what patients experience between clinic visits matters just as much as what clinicians observe. New FDA guidance is pushing sponsors toward more frequent, more targeted patient-reported outcome assessments across five core domains, from disease symptoms to role...
AI in Medical Information: Challenges, Opportunities, and the Path to Compliant Content at Scale
Medical information teams are being asked to do more with less; faster turnaround, broader content demands, and zero tolerance for inaccuracy. AI offers a way forward, but adoption comes with real challenges: how do you validate accuracy, integrate literature review, and build...
Xtalks | Improve Recruitment Outcomes Through More Diverse Clinical Trials
Since the advent of artificial intelligence (AI), medical device manufacturers have been early adopters for product enhancements. Now, manufacturers are evaluating their regulated content and other production processes for suitable applications of AI and automation technology. ...
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...
5 Common eCOA Migration Issues
This post discusses five common ECOA migration issues and provides solutions to overcome them. Keywords: ECOA migration, common issues, solutions....
A Checklist for eCOA Solution Deployment: Best Practices and Considerations
Selecting and deploying a new eCOA solution involves many important factors - from determining the capabilities of the Language Service Provider (LSP) to identifying the technology used for each COA migration - and it’s impossible not to worry about missing a key detail in the...
Fortune 500 Pharma Company Meets Critical Deadlines with TransPerfect Life Sciences’ COA Solutions
This spotlight reviews the challenges faced by a Fortune 500 pharmaceutical company in implementing Clinical Outcome Assessments (COAs) to measure the impact of their products on patients. It discusses the need for accurate and culturally appropriate translations of COAs for...
Successful English Build & Language Migration
Over the past decade, the global clinical trial landscape has changed drastically. A surge in technological innovation, including wearable devices, patient portals, and apps, has modernized how clinical data is collected and managed. With pen and paper becoming obsolete in the...
Why 75% of Medical Device Manufacturers Are Disappointed with Their AI Results
Most medical device AI programs fail before they start. Find out why, and what the top 20 percent do differently in their medical device translation processes....
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...