Clinical Data Talks

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Clinical Data Talks is your go-to podcast for an in-depth look at the evolving world of clinical data capture, management and analysis. Join industry experts and clinical data enthusiasts as we explore the challenges, breakthroughs and innovations shaping the industry. Through fresh perspectives, real-world experiences and forward-thinking discussions, we keep you informed on the latest trends driving the future of clinical trials. Whether you’re a data manager, researcher or passionate about the industry, Clinical Data Talks is your trusted source for insights into the world of clinical data.

  1. 5月27日 ·  ビデオ

    Unlocking Latin America's clinical trial potential with Claudia Rodriguez

    Sylvain Berthelot welcomes Claudia Rodriguez, CEO of RARAS, a CRO specialized in conducting research across Latin America. Together, they explore the untapped potential of this diverse region and why it is increasingly becoming a strategic priority for global sponsors. With a deep passion for the Latin American market, Claudia dispels common myths about the region’s accessibility and infrastructure. She shares how the landscape is shifting from a traditional focus on Phase 3 "rescue" trials toward early-phase research, driven by geopolitical changes and a growing need for diverse genetic data. Sylvain and Claudia discuss the nuances of different markets, from Chile’s rapid regulatory timelines for medical devices to Brazil’s world-renowned Key Opinion Leaders. They also delve into the unique cultural bond between patients and physicians in the region, which results in remarkably high retention rates. Tune in to our Season 3 finale to discover how strategic planning in Latin America can accelerate regulatory approval, provide a "soft landing" for future product launches, and ensure high-quality data that meets the rigorous standards of the FDA and EMA.

    Unlocking Latin America's clinical trial potential with Claudia Rodriguez

  2. 5月13日 ·  ビデオ

    The reality of data fragmentation in clinical trials with Kavita Gaadhe

    In this episode of Clinical Data Talks, Sylvain Berthelot welcomes Dr. Kavita Gaadhe, a clinical data management lead working at the high-stakes intersection of technology and precision medicine. Together, they explore the increasingly complex reality of managing non-linear data flows in a digitalized landscape. With expertise in navigating the "data mesh" of modern trials, Kavita shares how data managers are no longer just handling EDC systems but are now coordinating a symphony of sources: from multi-omics and imaging to device data and patient-reported outcomes. She explains the friction that occurs when these heterogeneous sources "speak different languages," forcing data teams to spend their days reconciling time points and bridging semantic gaps to meet standardization requirements. Sylvain and Kavita discuss why the industry is currently attempting to bolt 21st-century data onto 20th-century infrastructure, the necessity of viewing data as a strategic asset rather than a byproduct, and why oncology and precision medicine trials demand flexibility from technology first and foremost. Tune in to learn why a holistic mindset shift in vendor selection and a learner’s attitude are essential for surviving—and thriving—in today’s complex clinical data environment.

    The reality of data fragmentation in clinical trials with Kavita Gaadhe

  3. 4月29日 ·  ビデオ

    Clinical data from the patient's perspective with Ella Balasa

    In this episode of Clinical Data Talks, Sylvain Berthelot welcomes Ella Balasa, a patient advocate and leading voice in shaping collaborative approaches to clinical research. Together, they explore the critical importance of embedding the patient voice into every stage of the clinical trial lifecycle to ensure research is truly inclusive and effective. With a deep personal history of navigating the healthcare system as a cystic fibrosis patient, Ella shares the stark realities of trial participation: from the struggle for awareness in rural communities to the heavy physical and logistical burdens of complex procedures. She provides a poignant account of how rigid exclusion criteria can prevent the very patients who need new therapies most from contributing to essential data. Sylvain and Ella discuss why the industry must move beyond traditional endpoints to capture what truly impacts a patient’s quality of life. They also dive into the necessity of optionality, explaining how flexible trial designs can improve enrolment, reduce attrition, and accelerate timelines. Tune in to discover how true partnership between sponsors, regulators, and patient communities can transform trial design from a "one-size-fits-all" model into a meaningful, data-rich collaboration.

    Clinical data from the patient's perspective with Ella Balasa

  4. 4月15日 ·  ビデオ

    The adoption of centralized monitoring by CROs with Jennifer Stewart

    Sylvain Berthelot welcomes Jennifer Stewart, Vice President AI and Innovation at Premier Research and an active member of ACRO’s Risk-Based Quality Management (RBQM) working group. Together, they explore the current state of RBQM adoption and what it will take for the industry to fully embrace risk-based approaches in clinical trials. Drawing on insights from ACRO’s annual industry survey, Jennifer shares a candid view of where progress is being made, and where challenges remain. While awareness of RBQM is high, true adoption is still inconsistent, with many organisations implementing elements in isolation rather than as a fully integrated strategy. She explains how this partial adoption limits the overall impact on trial quality and efficiency. Sylvain and Jennifer discuss the key barriers holding the industry back, from persistent reliance on traditional practices like 100% SDV to misconceptions about regulatory expectations. They also highlight the growing role of regulators in encouraging risk-based approaches and why clearer communication and industry confidence are critical to driving change. Tune in to explore how RBQM is evolving, what the latest data tells us about adoption trends, and why shifting mindset – not just technology – is essential to unlocking its full potential.

    The adoption of centralized monitoring by CROs with Jennifer Stewart

  5. 4月1日 ·  ビデオ

    Innovation in a risk-averse industry with Adam Walker

    In this episode of Clinical Data Talks, Sylvain Berthelot welcomes Adam Walker, a seasoned clinical data management and biometrics consultant. Together, they explore the delicate balance between innovation and the inherently risk-averse nature of the clinical research industry. With extensive experience working for companies of various sizes, Adam has had the opportunity to observe and lead the implementation of innovation. In this episode, he shares his observations and discusses the tension between innovation and established processes, highlighting how legacy workflows can sometimes limit progress. He and Sylvain reflect on the challenge of introducing new technologies into environments where teams are incentivized to avoid risk, and where change can feel disruptive rather than enabling. Adam makes an important point about the importance of mindset and culture. He emphasizes that innovation is not just about technology itself, but about creating an environment where teams feel confident to challenge the status quo, rethink processes, and adopt new ways of working. Tune in to explore how the clinical industry can strike the right balance between stability and innovation, why risk aversion can both protect and hinder progress, and what it will take to unlock meaningful transformation in clinical trials.

    Innovation in a risk-averse industry with Adam Walker

  6. 3月18日 ·  ビデオ

    The role of standardisation in clinical trials with Chris Decker

    Podcast Episode Summary In this episode of Clinical Data Talks, Sylvain Berthelot welcomes Chris Decker, President and CEO of Clinical Data Interchange Standards Consortium (CDISC). Together, they explore the critical role that data standards play in modern clinical research and why greater standardisation is essential to improving how clinical trial data is collected, structured, and shared. Drawing on decades of experience in clinical technology and data solutions, Chris explains how CDISC standards have become a foundation for regulatory submissions and global data interoperability. He highlights what those standards enable to do, but also the work ahead of us to truly achieve the digital transformation the industry needs. A key theme of the conversation is the growing importance of digitizing protocols and designing studies with standards in mind from the beginning. Chris shares how structured protocol models and machine-readable standards could transform study setup, reduce manual work, and enable greater automation across the clinical data lifecycle. Tune in to discover how CDISC standards are shaping the future of clinical trials, why protocol digitization could be a turning point for the industry, and how better data foundations can unlock innovation in clinical research.

    The role of standardisation in clinical trials with Chris Decker

  7. 2025/11/26 ·  ビデオ

    Beyond the data: Human stories from clinical trials in Ukraine

    In this final episode of season 2, Sylvain Berthelot welcomes Anna Titkova, who shares her first-hand experience of running clinical trials in Ukraine before and during the conflict. In 2022, Anna lived in Ukraine and acted as the country head for Pratia, a research site network. Anna describes how Ukraine, once a thriving hub for international clinical research, was suddenly forced to adapt to unprecedented challenges. From halting patient recruitment and struggling with the shipment of investigational medicines, to relocating vulnerable oncology patients across borders, she paints a vivid picture of resilience and resourcefulness under pressure. Together, Sylvain and Anna discuss the rapid regulatory adaptations that allowed continuity of care, the growing demand for clinical trial participation among internally displaced persons, and the remarkable story of a young patient whose treatment continued thanks to cross-border collaboration. Tune in to hear how clinical trials in Ukraine have not only survived but are resurging, and why patient trust, unity, and human-centered approaches are shaping the future of research in the region.

    Beyond the data: Human stories from clinical trials in Ukraine

  8. 2025/11/12 ·  ビデオ

    The impact of geopolitics in clinical trial location with Scott Schliebner

    In this episode, Sylvain Berthelot welcomes Scott Schliebner, Global Head of Drug Development Consulting at Novotech. With over 25 years of experience across CRO leadership roles, Scott brings a unique perspective on how global politics and shifting market dynamics are influencing where – and how – clinical trials are run. Together, Sylvain and Scott explore the growing uncertainty created by political change, regulatory shifts, and economic pressures, and how these factors are shaping sponsor strategies. From the rise of early-phase studies in Australia and New Zealand, to the diversification of phase III trial geographies, they discuss why sponsors are increasingly reluctant to rely on a U.S.-only model. Scott explains how geopolitical factors such as trade tensions, FDA staffing challenges, and evolving diversity guidance impact trial planning, and why sponsors must think proactively about data representativeness across regions. The conversation also highlights the scientific – rather than political – benefits of conducting multi-regional trials, ensuring that new medicines reach the patients who need them most. Tune in to discover how sponsors are mitigating risk, balancing timelines and costs, and navigating the new realities of trial globalization.

    The impact of geopolitics in clinical trial location with Scott Schliebner
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番組について

Clinical Data Talks is your go-to podcast for an in-depth look at the evolving world of clinical data capture, management and analysis. Join industry experts and clinical data enthusiasts as we explore the challenges, breakthroughs and innovations shaping the industry. Through fresh perspectives, real-world experiences and forward-thinking discussions, we keep you informed on the latest trends driving the future of clinical trials. Whether you’re a data manager, researcher or passionate about the industry, Clinical Data Talks is your trusted source for insights into the world of clinical data.

情報

  • クリエイター
    CRScube
  • 配信期間
    25年 - 26年
  • エピソード
    18
  • 制限指定
    不適切な内容を含まない
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    © Copyright 2025 All rights reserved.
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