LifeSci Talks

Are We Sacrificing Good for Perfect in Clinical Outcome Assessment?

TransPerfect Life Sciences — Tue, 05 May 2026 09:00:00 +0000

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 sacrificing “good for perfect.” Together, they explore the role of regulatory guidance and clinical development timelines, specifically the role of measurement science in already tight development timelines, when to modify a legacy instrument versus build something new, and why getting measurement scientists involved early is the key to a successful COA strategy.

More Than an Aspiration: Building a Patient-Centric Evidence Strategy That Lasts

TransPerfect Life Sciences — Mon, 23 Mar 2026 09:00:00 +0000

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 evidence strategy that spans the entire drug development pathway. Together, they examine the growing role of COA and in-study interviews in regulatory decision-making, the practical barriers to earlier patient engagement. They explore how eCOA providers could add greater value by getting involved long before a pivotal trial, and a focus on why the choice of data capture modality matters far more than the industry currently recognizes.

Building Fit-for-Purpose PRO Instruments: Focused Modern Measures Over General Instruments

TransPerfect Life Sciences — Tue, 10 Feb 2026 10:00:00 +0000

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 development. They discuss diaries and quality of life tools, rare disease challenges, and proxy reporting, as well as the tradeoffs that can often occur in balancing regulatory rigor, patient burden, and realistic instrument usability. Listen in to hear why multiple instruments for the same disease can often create not only frustration for patients, but can also overburden them simultaneously. The episode will share suggestions as to how study teams can design smarter, more patient-centered measurement strategies.

Meaningful patient involvement in HTA decision making: where do we go from here?

TransPerfect Life Sciences — Tue, 07 Oct 2025 12:00:00 +0000

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Alice Biggane, Outcomes Innovation and Research Lead at Pfizer UK, to discuss how various PRO measures inform and impact reimbursement decisions for HTA driven markets. Together they unpack what data sources and methods exist for the quantification and understanding of HRQoL for cost-effectiveness decision making and the complex interplay between the need to reduce burden and increase transparency through standardization, while maintaining the crucial and nuanced balance of different stakeholder requirements. Tune in to learn how leading organizations are working to build more inclusive, efficient, and patient-focused clinical trials, and accelerating patient-access to new health technologies.

Silver Bullet or Useful Repositories: The Reality of Clinical Trial Libraries

TransPerfect Life Sciences — Thu, 11 Sep 2025 13:00:00 +0000

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, is joined by Jonathan Norman, Director of Translation and Localization at YPrime, for an in-depth discussion on the realities of eCOA libraries. Together, they explore why “libraries” are more accurately described as asset repositories, the conditions under which reuse can meaningfully accelerate study timelines, and the limitations that prevent them from being a universal solution. The conversation highlights both the efficiencies and challenges of reuse, providing clarity on how sponsors and providers can better align expectations in clinical trial execution.

Modernizing eCOA: Emulators, Backups, and the Future of Reporting

TransPerfect Life Sciences — Fri, 01 Aug 2025 08:00:00 +0000

In this tech-forward episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, welcomes Indira Jain-Figueroa, Product Director at Evinova, for a deep dive into the ever-evolving landscape of eCOA development. Covering everything from cross-platform development, backups, and emulator use to the future role of AI in reporting, this conversation highlights how innovation can improve both user experience and study efficiency in clinical trials.

Balancing Innovation and Integrity: AI’s Place in Patient-Focused Research

TransPerfect Life Sciences — Tue, 01 Jul 2025 08:00:00 +0000

Artificial intelligence is redefining what’s possible across the clinical development lifecycle, but with rapid innovation comes the need for thoughtful oversight. In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Richard “RJ” Kedziora, Co-Founder of Estenda Solutions, to explore how AI is transforming clinical research and digital health. From scaling informed consent through digital avatars to detecting patient emotion using voice and behavioral cues, they dive into the practical applications, ethical challenges, and future potential of AI in patient-centric trials.

Making the Most of Smaller Population Samples: Qualitative Insights in Rare Disease

TransPerfect Life Sciences — Fri, 23 May 2025 09:50:00 +0000

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Dr. Kate Williams, Director of Patient-Centred Outcomes Research at Acaster Lloyd, to explore the nuances of gathering and applying qualitative data in rare disease research. From intaking both the patient and caregiver experience using a narrative approach, to qualitatively describing the experience of living in different disease states, the two focus on the importance of capturing the patient experience beyond the numbers. Tune in and hear about how partnering with patient organizations can help amplify findings across various channels in ways that make sense to every stakeholder, from regulator to clinician to patient.

Bonus resource: Check out the paper Dr. Kate Williams references on AADC in the episode here!

Data Without Interpretation is Meaningless: Unlocking Inherent Value Within the Numbers

TransPerfect Life Sciences — Tue, 25 Feb 2025 05:00:00 +0000

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Elizabeth (Nicki) Bush, Executive Director and Global Head of Endpoint Strategy and COA Measurement at OPEN Health Group to discuss the growing complexity of collecting and interpreting patient data. With insights from the recent FDA workshop around Patient-Focused Drug Development (PFFD), the two discuss the importance of integrating measurement science early in the study design, improving data quality while minimizing patient burden, and ensuring patient data is not just gathered, but meaningfully applied in regulatory submissions.

Measuring What Matters: Modernizing Clinical Outcome Assessments with Patient-Centric Approaches

TransPerfect Life Sciences — Mon, 25 Nov 2024 14:58:41 +0000

In this episode of LifeSci Talks, TransPerfect’s Global Practice Leader Mark Wade sits down with Dr. Karl McEvoy, VP of eCOA and Patient Technology at YPrime, to discuss the importance of embracing technology in clinical research to reduce the patient burden. The two cover everything from updating legacy instruments to more modern solutions such as using video assessments, to incorporating caregiver and patient advocacy groups input for reshaping trial design. Listen in for insights on strategies that balance data collection with the demands of an ever-evolving global clinical landscape to drive meaningful outcomes.

Effective Rater Training: A Critical but Overlooked Part of COA Administration

TransPerfect Life Sciences — Fri, 08 Nov 2024 16:54:19 +0000

In this episode of LifeSci Talks, TransPerfect Life Sciences’ Global Practice Leader Mark Wade sits down with Kelly Dumais PhD, Director of eCOA Science at Clario to discuss the significance rater training plays in standardizing the administration and scoring of clinical scales. Aiming to reduce bias and enhance data quality, you’ll hear about potential strategies for better engaging patients and how comprehensive proactive training can reduce patient and site burden. Listen to key insights around developing training programs as the two dive into the importance of standardized rater training across diverse clinical settings for maintaining data quality.

From Interview to Endpoint: Understanding the Importance of Patient Listening to Build Better Outcomes

TransPerfect Life Sciences — Thu, 08 Aug 2024 22:10:00 +0000

In this episode of TransPerfect LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences sits down with John Reites, Co-Founder and CEO of THREAD research to discuss the importance of patient listening and in-study interviews to build better clinical trial endpoints. They delve into the differences between enterprise and point solutions, challenges with standardization, and the influence of evolving technologies in the eCOA industry.

Exploring the Value Add of In-Study Interviews as a critical COA Endpoint

TransPerfect Life Sciences — Wed, 26 Jun 2024 17:07:16 +0000

In this episode of TransPerfect LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences sits down with Tom Willgoss, Patient-Centered Outcomes Research Chapter Lead, UK Site Head for Data Sciences at Roche to discuss the value of understanding and measuring patient experience data throughout the clinical journey. They delve into the significance of patient-centered clinical outcome assessments for endpoint selection in clinical trials, prioritizing diversity and inclusion across global clinical sites with the help of translation services providers, and shifting trends towards DCTs.

Breaking the Hype Cycle: An Objective Look at Remote Research Strategies in DCTs

TransPerfect Life Sciences — Tue, 26 Mar 2024 04:00:00 +0000

In the first part of TransPerfect's latest LifeSci Talks episode, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, with guest Dr. Michelle Longmire, CEO of Medable, spoke about how a Stanford doctor transitioned into a career of entrepreneurship, creating a multimillion dollar eClinical company. Continuing the conversation in part two, the pair explore the commercial aspects of e-clinical solutions, particularly focusing on the landscape of Decentralized Clinical Trials (DCT). The conversation centers around evolution of DCT during the pandemic, the merging of DCT with Electronic Clinical Outcome Assessments (ECOA), and the need for a hybrid approach - balancing remote and on-site research modalities. There is an emphasis on the importance of prioritizing core measurements over excessive data collection, leveraging technology for speed, scale, and access, and envisioning a future where digital transformation enhances clinical research outcomes.

Exploring the Intersection of Clinical Practice and Entrepreneurship: Technological Innovation in Clinical Research

TransPerfect Life Sciences — Tue, 26 Mar 2024 04:00:00 +0000

 In this episode of TransPerfect LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Dr Michelle Longmire, CEO of Medable, to discuss her journey from clinical practice to entrepreneurship, driven by a passion for rare disease, and the need for technological innovation in clinical research. The conversation highlights key challenges faced in transitioning from academia to entrepreneurship, and the importance of storytelling in securing funding. Key facets of success in this realm place emphasis on assembling diverse teams with expertise in platform technologies, enterprise architecture, and how collaboration between technologists and clinical research experts helps build scalable clinical research solutions.

PRO Scheduling Considerations: Assessing Patient & Caregiver Burden in Clinical Trials

TransPerfect Life Sciences — Tue, 27 Feb 2024 10:54:20 +0000

In this episode of TransPerfect LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences sits down with Andrew Lloyd, Director at Acaster-Lloyd Consulting, to spotlight the burden of clinical research for patients, and their caregiver/family dynamics. From ethical considerations surrounding patient/caregiver consent, to the intricate timing challenges of data collection, the conversation examines how involvement in a study impacts on disease states and patient wellbeing, with further insight into how burden is extended to families and caregivers.

Licensing Considerations and eCOA Vendor Collaborations

TransPerfect Life Sciences — Tue, 30 Jan 2024 05:00:00 +0000

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Stacey Higgins, Associate Director, COA & Digital Implementation Team at AbbVie, to cover the intricacies of clinical trial licensing, contract variations among eCOA providers, the importance of sponsor involvement, and the challenges of validated translations. Explore the complexities that can arise in these critical aspects of clinical trials

Decoding Decentralized Trials: Navigating Novel Decentralized Research Challenges and Complexity with Craig Lipset

TransPerfect Life Sciences — Mon, 18 Dec 2023 14:43:23 +0000

DCTs have picked up significantly in previous years, catalyzed by the pandemic and a move to remote research. With this move comes a host of new challenges, including those surrounding technical interoperability, resistance to adopting new technologies, and the need for flexibility in technology uptake at research sites. With additional considerations to be made, such as ensuring regulatory compliance, and enforcing standardized metrics in assessing DCT performance, this episode provides valuable insight into the dynamic and relatively novel landscape of decentralization in clinical trials.

AI-Powered Innovations in Clinical Trials: Optimizing Every Step with Shae Wilkins

TransPerfect Life Sciences — Tue, 28 Nov 2023 14:24:29 +0000

Explore how artificial intelligence is rapidly changing the landscape of clinical trials, from discovering new therapies and complex calculations to protocol optimization. Discover how AI can generate study protocols, consent forms, and more, saving time and resources. Join us to unravel the potential of AI in reshaping the future of medical research and clinical trial operations.

The Age of Bring Your Own Device: Considerations for Accessibility in Trial Design with Dr. Florence Mowlem

TransPerfect Life Sciences — Tue, 31 Oct 2023 14:02:31 +0000

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences, sits down with Dr. Florence Mowlem, VP of Science at ObvioHealth, to discuss maximizing patient accessibility in trial design. This includes implementing accommodations for patients with physical and cognitive limitations, and ensuring thoughtful applications of electronic modalities.

Data Science: The New Frontier with Dr. Elizabeth Bacci

TransPerfect Life Sciences — Thu, 28 Sep 2023 13:47:00 +0000

In this episode of LifeSci Talks, Mark Wade, Global Practice Leader at TransPerfect Life Sciences sits down with Dr. Elizabeth Bacci, Senior Research Scientist at Evidera., to discuss critical aspects of developing meaningful and relevant Digital Health instruments. The conversation emphasizes the importance of aligning digital health tools with individual patient needs, and prioritizing the patient's perspective when developing instruments that are fit for purpose in today’s patient outcomes, conducting qualitative interviews and defining meaningful relevant endpoints.

The Future of Capturing Patient Data in Clinical Trials: DCTs, Site Staff Burden, and Regulation Considerations with Paul O'Donohoe

TransPerfect Life Sciences — Tue, 29 Aug 2023 04:00:00 +0000

Mark Wade interviews Paul O'Donohoe, Senior Director of Product for eCOA and COA at Medidata. They delve into the challenges and opportunities of adopting decentralized clinical trials (DCTs) and explore topics such as mixed modalities for data capture, patient burden, site-centricity, HTML5-based app wrappers, regulatory advancements during the pandemic, and the importance of flexibility in clinical trial technology adoption.

Building a Successful Partnership: Meeting Sponsor Expectations with Aaron McCormick

TransPerfect Life Sciences — Fri, 25 Aug 2023 15:45:00 +0000

Tune in to our chat with Aaron McCormick, Associate Director, eCOA Implementation at Moderna, to unravel the importance of standardized eCOA systems across trials and indications. Explore compliance reporting, document management, and TMF guidelines, and gain invaluable insights for successful trial execution and inspection readiness.

Harnessing Implementation Science to Improve Health Outcomes: Methods and Approaches for the Future with Meredith Smith

TransPerfect Life Sciences — Fri, 11 Aug 2023 16:45:46 +0000

What is implementation science, and how can it revolutionize patient-centered healthcare? Join Dr. Meredith Smith in conversation with Mark Wade as they discuss this systematic approach to bridging the gap between healthcare innovations and routine settings. Explore its potential to improve patient outcomes and reduce therapy wastage, while gaining attention from regulatory authorities.

Considerations and Opportunities in Capturing Oncology Patients’ PRO Data with Bill Byrom

TransPerfect Life Sciences — Fri, 11 Aug 2023 16:40:55 +0000

In this episode, host Mark Wade is joined by Bill Byrom, the VP of Product Intelligence and Positioning at Signant Health, as they explore the world of capturing data from oncology patients and discuss the challenges of traditional data collection methods using quality-of-life instruments during clinic visits.

Children Are Not Just Small Adults: Considerations for Improving the Pediatric Experience with Elin-Haf Davies

TransPerfect Life Sciences — Fri, 04 Aug 2023 14:50:00 +0000

In our first episode of LifeSci Talks, Global Practice Leader & COA SME of TransPerfect Life Sciences sits down with Dr. Elin Haf Davies, CEO of Aparito, to discuss the need for child-friendly study designs and endpoints in pediatric clinical trials, highlighting the potential impact on future generations.