Thought Leadership
MDR SSCPs and IVDR SSPs Are NOT Labeling: What That Means for Your EUDAMED Upload
By February 27, 2027, medical device and IVD manufacturers must upload their validated, translated SSCPs and SSPs to EUDAMED themselves, and many haven’t budgeted for the translation work this requires. Most companies translate these documents the same way they translate labeling...
Are Legacy COA Instruments Still Fit for Purpose?
Kathrin Fischer, PhD, and Mark P. Wade discuss whether decades-old COA instruments still reflect how patients live and respond today....
eConsent: Why the Content Matters as Much as the Tech
Learn why better eConsent starts with reusable, patient-centered content, not technology alone. ...
Has eCOA Lived up to Its Promise? A Retrospective View on the Evolution of Electronic Clinical Outcome Assessments
Two decades in, electronic clinical outcome assessment has transformed clinical research without fully replacing paper. The next wave of innovation (AI-assisted design, reduced site burden, and true interoperability) could finally change that. Discover where eCOA stands today and...
Breaking Down Silos: The Key to Effective Collaboration and Safety Signal Management
Learn how breaking down operational silos across medical information, pharmacovigilance, and regulatory affairs strengthens safety signal management and safeguards patients....
Regulatory Considerations for Paper COA Translations | What You Need to Know
Managing paper COA translations for global clinical trials means navigating multiple regulatory frameworks that don't share a timeline or coordinate with each other. From ICH E6 and ISPOR guidelines to FDA PRO guidance and copyright licensing requirements, sponsors need to...
When "How Does the Patient Feel?" Became a Regulatory Question
For decades, "how does the patient feel?" was treated as supporting color in a clinical trial, not proof. That's changing fast. FDA guidance for PRO measures has moved patient-reported outcomes from the periphery of trial design toward primary and co-primary...
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...
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...
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...
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...
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....
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...
AI Content Creation and Maintenance in Medical Information: Ending the Content Whack-a-Mole
For medical information teams, content maintenance can feel like an endless game of whack-a-mole. Update one answer, and three more fall out of sync. AI-powered platforms are changing that, giving MI teams a central source of truth to create, maintain, and deliver compliant...
When Licensing Becomes the Bottleneck: Lessons from a Sponsor on COAs, eCOA Vendors, and Getting It Right
FDA clinical outcome assessment strategy starts with licensing, translation, and vendor alignment. Learn how to protect trial integrity and keep patients first....
Medical Device Localization: Navigating Compliance and Empowering Engagement
As MDR, IVDR, and digital health expectations rise, manufacturers need a scalable strategy that spans certified translation, UX adaptation, validation, and ongoing content management. Explore how the right mix of expertise and technology turns localization from a compliance...
The Role of AI and Machine Learning in Clinical Outcome Assessment Translation
Automation can accelerate clinical workflows, but COA translation requires more than just AI on its own. Learn how to balance efficiency with scientific validity....
Why Global Medical Affairs Can’t Ignore Website Localization
If your global medical content lives online, language gaps can turn into risk fast. This post breaks down what to prioritize, how to avoid version drift, and how to keep approvals moving without creating an IT choke point when…...
Clinical Trials Translation Management: A Scalable Workflow for Faster Enrollment
Recruitment content is part of the participant experience. So, updates can’t be an afterthought. This blog explores the practical steps teams use to keep messaging consistent, approvals traceable, and pages up to date when…...
7 Workflow Hacks for Smarter Clinical Trial Localization
Multiple languages. Constant updates. Too many reviewers. If your trial site feels like controlled chaos, you’re not alone. Here’s how teams keep every market aligned, shorten review cycles, and publish faster. Starting with…...