Thought Leadership
LifeSci Talks COA Series | eConsent: Why the Content Matters as Much as the Tech
In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Edwin Cohen, Principal Consultant at C&Flow, to talk about eConsent adoption in clinical trials. They discuss the research behind why animated, electronic consent...
XTalks | How MI, PV & Regulatory Collaborate on Signals, Labeling, Crisis Response and AI
Medical Information (MI), Pharmacovigilance (PV) and Regulatory Affairs (RA) each play distinct but deeply interconnected roles in ensuring that therapeutics are safe, accurately labeled and compliantly communicated to healthcare professionals and patients. Yet in practice, the...
LifeSci Talks COA Series | Nothing Remains the Same: Why Measures Have to Evolve
In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with RJ Wirth, CEO and Consulting Psychometrician at Vector Psychometric Group, to talk about why the measures we rely on are living things rather than fixed artifacts....
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...
XTalks | eCOA: Has It Lived Up to the Promise? A Realistic Assessment for Today's Trials
Despite two decades of technological advancement, the debate between paper and electronic clinical outcome assessments (eCOA) remains unresolved. This webinar revisits the assumptions that continue to shape data collection strategies and examines whether current practice reflects...
Top 10 Pharma Company Overhauls Global COA Program,Cutting Costs by 33% and Errors to Near Zero
Inconsistent standards, stretched timelines, and limited visibility were straining a top 10 pharma company's COA program. Discover how TransPerfect Life Sciences' centralization strategy delivered 99.7% accuracy, 40% less PM oversight, and 33% cost savings across the...
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...
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...
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....
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...
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...
LifeSci Talks COA Series | More Than an Aspiration: Building a Patient-Centric Evidence Strategy That Lasts
In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Lina Eliasson PhD CPsycho, Founding Partner at Sprout Health Solutions, to discuss how pharma companies of all sizes can build a comprehensive, patient-centric...
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....
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....
LifeSci Talks COA Series | Building Fit-for-Purpose PRO Instruments: Focused Modern Measures Over General Instruments
In this episode of LifeSci Talks, Mark Wade, Global Practice Leader & COA SME at TransPerfect Life Sciences, is joined by Katja Rudell, VP of Patient-Centered Outcomes at Kielo Research, to take a behind-the-scenes look at the reality of patient-centered instrument...
Back to the Basics: Foundations of COA Localization
COA translation isn’t as simple as swapping words from one language to another—patient concepts rarely map cleanly across cultures. This blog brings us back to the basics of clinical outcome assessment localization, breaking down why linguistic validation exists, what regulators...
Optimizing COA/eCOA Workflows with Technology for Better Quality & Timelines
Efficient workflows are critical to keeping global COA/eCOA studies on schedule while ensuring the quality of localized content. This live webinar will explore how technology stacks and automation can streamline clinical localization from start to finish, through integrating...
Integrating eCOAs and Digital Health for Patient-Centric Trials
Learn how eCOA integration with digital endpoints and connected platforms enhances patient engagement and operational efficiency in clinical trials....