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Phase Forward
Podcast Series hosted by Valerie Coveney
34 episodes
1 week ago
In this episode, Isabel Dorion, Senior Director of Clinical Operations at Indero, shares expert insights on the critical role of Clinical Research Associates (CRAs) in ensuring trial quality and patient safety. Explore key strategies for effective CRA oversight and discover how quality reviews and adaptive risk-based monitoring enhance compliance and data integrity. Tune in for practical guidance on maintaining excellence in clinical monitoring and elevating trial outcomes.
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Health & Fitness
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All content for Phase Forward is the property of Podcast Series hosted by Valerie Coveney and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
In this episode, Isabel Dorion, Senior Director of Clinical Operations at Indero, shares expert insights on the critical role of Clinical Research Associates (CRAs) in ensuring trial quality and patient safety. Explore key strategies for effective CRA oversight and discover how quality reviews and adaptive risk-based monitoring enhance compliance and data integrity. Tune in for practical guidance on maintaining excellence in clinical monitoring and elevating trial outcomes.
Show more...
Health & Fitness
Episodes (20/34)
Phase Forward
Episode 34: Elevating Clinical Research Associate Oversight for Quality and Impact
In this episode, Isabel Dorion, Senior Director of Clinical Operations at Indero, shares expert insights on the critical role of Clinical Research Associates (CRAs) in ensuring trial quality and patient safety. Explore key strategies for effective CRA oversight and discover how quality reviews and adaptive risk-based monitoring enhance compliance and data integrity. Tune in for practical guidance on maintaining excellence in clinical monitoring and elevating trial outcomes.
Show more...
3 weeks ago
11 minutes 18 seconds

Phase Forward
Episode 33: Beyond Safety: The Evolving Complexity of Early Phase Studies
In this episode of Phase Forward, Dr. Ana Palijan explores how early phase clinical trials have evolved beyond their traditional safety focus. With over 25 years in translational research, she discusses the growing complexity driven by scientific advances, technology integration, and global trial execution. Dr. Palijan highlights the shift toward context-specific strategies, the double-edged role of digital systems, and the rising value of niche CROs. She also examines the operational challenges faced by small biotech companies and the importance of aligning trial design with study intent. Tune in for a deep dive into the future of early clinical development.
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1 month ago
19 minutes 7 seconds

Phase Forward
Episode 32: Strategic Storytelling: The Role of PR in Biotech & Pharma Stakeholder Engagement
In this episode, Sarah Ballard, Agency Director at KDM, dives into the strategic power of PR in navigating the complex world of scientific and clinical communications. With over 20 years in B2B marketing, Sarah reveals how public relations drives trust and credibility amid digital disruption and stringent regulations. Explore how value-driven storytelling aligns with business growth, stakeholder expectations, and investor confidence. The episode also unpacks real-world challenges like reputation fragility, AI’s role in content creation, and the necessity of human nuance.
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2 months ago
11 minutes 18 seconds

Phase Forward
Episode 31: Dos and Don'ts for Sponsors and CROs in Site Collaborations – Part 3: Payments
In the Season 3 finale of Phase Forward, clinical research veterans Ted Trafford and Brad Hightower share essential insights on building stronger collaborations between sponsors, CROs, and clinical trial sites. Drawing from decades of hands-on experience, they explore how sustained site motivation, protocol clarity, and fair financial practices directly impact study success. Ted, who expanded Probity Medical Research into a global network, and Brad, founder of Hightower Clinical and host of Note to File, offer practical strategies and real-world examples. This 3-part series is a must-listen for sponsors seeking to elevate site relationships and drive more efficient, effective trials.
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4 months ago
18 minutes 16 seconds

Phase Forward
Episode 30: Dos and Don'ts for Sponsors and CROs in Site Collaborations – Part 2: Focus on Protocol
In the Season 3 finale of Phase Forward, clinical research veterans Ted Trafford and Brad Hightower share essential insights on building stronger collaborations between sponsors, CROs, and clinical trial sites. Drawing from decades of hands-on experience, they explore how sustained site motivation, protocol clarity, and fair financial practices directly impact study success. Ted, who expanded Probity Medical Research into a global network, and Brad, founder of Hightower Clinical and host of Note to File, offer practical strategies and real-world examples. This 3-part series is a must-listen for sponsors seeking to elevate site relationships and drive more efficient, effective trials.
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4 months ago
14 minutes 23 seconds

Phase Forward
Episode 29: Dos and Don'ts for Sponsors and CROs in Site Collaborations – Part 1: Site Engagement
In the Season 3 finale of Phase Forward, clinical research veterans Ted Trafford and Brad Hightower share essential insights on building stronger collaborations between sponsors, CROs, and clinical trial sites. Drawing from decades of hands-on experience, they explore how sustained site motivation, protocol clarity, and fair financial practices directly impact study success. Ted, who expanded Probity Medical Research into a global network, and Brad, founder of Hightower Clinical and host of Note to File, offer practical strategies and real-world examples. This 3-part series is a must-listen for sponsors seeking to elevate site relationships and drive more efficient, effective trials.
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4 months ago
18 minutes 27 seconds

Phase Forward
Episode 28: What is New With ICH E6 (R3)?
In this episode, Mélanie Pomerleau, Vice President of Quality and Compliance at Indero, joins us to explore the upcoming ICH E6 (R3) guideline revision. With over 25 years in the pharmaceutical and biotech industries, Mélanie shares expert insights on key changes, including the restructured document format, modernized GCP principles, enhanced patient centricity, and the integration of decentralized and adaptive trial designs. We also discuss evolving regulatory expectations, audit trends, and the growing importance of data governance. Tune in to understand how sponsors, CROs, and sites can prepare for the July 2025 implementation and navigate this transition.
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4 months ago
20 minutes 3 seconds

Phase Forward
Episode 27: How Genuine People Care Drives Business Success
In this episode, Beatriz Aguirre—an accomplished leader based in Spain with over 20 years of experience in the pharmaceutical industry—shares insights on building thriving, people-first workplaces. With a track record of leading international teams, Beatriz explores how a human-centric approach to leadership can transform organizational culture, elevate service quality, and drive financial performance. Listeners will gain practical strategies for fostering environments where individuals grow both professionally and personally. Tune in for a compelling conversation on the power of empathy, purpose, and authentic leadership in today’s evolving business landscape.
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5 months ago
23 minutes 35 seconds

Phase Forward
Episode 26: Optimizing Recruitment & Retention in Rheumatoid Arthritis Clinical Trials
In this episode, we are joined by Harley Skorpenske, a Clinical Research Associate II at Indero, who brings extensive experience in clinical research across various therapeutic areas, particularly dermatology and rheumatology. Harley's innovative approaches to patient recruitment and retention have significantly enhanced the success rates of numerous clinical trials. Together, we explore the optimization of recruitment and retention in Rheumatoid Arthritis (RA) clinical trials, discussing the challenges and considerations in recruiting participants, the impact of seasonal and environmental factors, and proven strategies to enhance recruitment and retention. Tune in to gain valuable insights from Harley's expertise and learn how to overcome common obstacles in RA clinical trials.
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5 months ago
13 minutes 1 second

Phase Forward
Episode 25: Navigating Strategies for Timelines, Communications, and Resilience
Join us in today's episode as we explore the complexities of global clinical trials with two industry experts. Lyn Mursalo, Director of Clinical Operations at Escient Pharmaceuticals, and Randa Wahid, Senior Project Manager at Indero, formerly known as Innovaderm, share their insights on maintaining realistic timelines, effective communication, and resilience in clinical trials. With decades of experience, they discuss strategies for coordinating multiple sites, leveraging technology for communication, and preparing for high-stakes decisions. Tune in to learn more.
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6 months ago
16 minutes 40 seconds

Phase Forward
Episode 24: Veeva—RTSM nightmares: avoiding the common pitfalls
In this special episode, we are joined by Veeva’s team for a round table discussion. We explore some of the most common mistakes in randomization and trial supply management (RTSM), share proactive steps to avoid these pitfalls, and explore real-life case studies with practical solutions. Joining our round table are Kelly O’Brien, RTSM Senior Project Manager at Veeva; Andrew Rohrbaugh, VP Strategy at Veeva RTSM; Éric Hardy, Senior Director of Biometrics at Indero (formerly Innovaderm); and Oliver Hewer, Project Manager at Indero. Tune in to gain valuable insights and practical advice from industry experts!
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7 months ago
22 minutes 23 seconds

Phase Forward
Episode 23: Innovaderm Becomes Indero
In this episode of Phase Forward, Jason Shuris, CBO of Indero (formerly Innovaderm), discusses the company's rebranding to Indero on March 7th, 2025. This change, which coincides with the 25th anniversary, marks an exciting expansion into rheumatology services alongside dermatology. The rebranding leverages Innovaderm's strong reputation in dermatology to introduce the Indero brand globally. The vision includes maintaining core values, scientific excellence, and high-quality service, as a dual-focused CRO.
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7 months ago
11 minutes 48 seconds

Phase Forward
Episode 22: Enhancing Clinical Trial Efficiency: 3 Essential CTMS Tips for Sponsors, CROs, and Sites
Robert Taylor, Associate Director of Clinical Operations at Innovaderm, joins us in an episode of Phase Forward. He shares his top 3 tips for improving clinical trial efficiency with CTMS. Learn how centralized data management, process automation, and remote monitoring tools can lower costs and enhance data quality. Perfect for sponsors, CROs, and sites looking to optimize their trials.
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8 months ago
11 minutes 18 seconds

Phase Forward
Episode 21: Maintaining clear and consistent communication among the sponsor, CRO, and site
In this episode, we welcome Laura Tomat, Senior Director and Project Management at Innovaderm, with over 25 years of experience in clinical trial management. Laura discusses the evolving nature of communication in clinical research, emphasizing the importance of transparency, optimizing communication, and personalizing interactions. She explores the economics of communication, balancing informative, concise, and accurate communication to benefit both sites and sponsors. Tune in for valuable insights into effective communication in clinical research.
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9 months ago
11 minutes 48 seconds

Phase Forward
Episode 20: AI-Driven Drug Development and Clinical Trials
In this episode, we dive deep into the world of AI-driven drug development and clinical trials. We welcome 3 distinguished guest speakers: Guillaume Gigon, Vice President of Technology and AI at Innovaderm; Nardin Nakhla, Co-Founder and CTO of Simmunome; and Christian Dansereau, Founder and CEO of Perceiv AI. Our roundtable discussion explores the challenges and benefits of integrating AI into clinical research, with a focus on neurological, immune, and dermatological fields. We discuss how AI accelerates drug discovery and enhances trial efficiency through predictive analytics. Finally, we look ahead to the future of AI in managing clinical trials and the next steps for this transformative technology.
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9 months ago
29 minutes 51 seconds

Phase Forward
Episode 19: Takeaways from CDISC TMF US Interchange
Join the conversation with Amélie Rivet, Associate Director of eTMF Operations at Innovaderm. With extensive experience managing global trials across North America, Europe, and Asia, Amélie brings a deep understanding of the clinical steps essential for successful trials, from start-up to close-out. Well-versed in regulatory requirements and skilled in managing multidisciplinary teams, she will share key insights from the CDISC TMF US Interchange conference held in Arizona last October. Tune in to gain valuable knowledge and stay informed about the latest trends in TMF management.
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10 months ago
11 minutes 1 second

Phase Forward
Episode 18: Key Considerations in Site Selection
This episode welcomes Faiza Tayar, a seasoned expert in site selection with over 16 years of experience in the pharmaceutical industry. Her strategic insights have significantly shaped Innovaderm's trajectory. We explore the critical aspects of site selection in clinical trials, focusing on site identification, choosing the right site, and expanding a site database. Do not miss this opportunity to gain a comprehensive understanding of this process.
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11 months ago
13 minutes 20 seconds

Phase Forward
Episode 17: Insights from Regulatory Affairs Professionals Society Convergence 2024
Join us as we welcome Despina Vasiliou, Innovaderm's Regulatory Affairs Manager. In this episode, Despina shares her insights from the Regulatory Affairs Professionals Society (RAPS) Convergence 2024, held in Long Beach. Topics include the impact of artificial intelligence, addressing unmet medical needs, regulatory conversations, solution circles, and valuable networking opportunities. Tune in for a deep dive into the latest trends and discussions shaping the regulatory landscape.
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11 months ago
15 minutes 57 seconds

Phase Forward
Episode 16: How Seasonality Affects Dermatology Patient Recruitment
We are thrilled to have Nadine Clervoix, Clinical Research Coordinator at Innovaderm, with 25 years of experience in clinical research. In this episode, we explore the impact of seasonality on dermatology clinical trial patients, covering 4 main points: effects on skin, lifestyle restrictions, study design, and patient retention. Join us as we explore how seasonal changes influence patient symptoms, treatment efficacy, and recruitment in clinical trials. Discover insights on managing these challenges and optimizing trial outcomes through strategic adjustments and innovative approaches, ensuring effective and efficient dermatology research throughout the year.
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12 months ago
8 minutes 58 seconds

Phase Forward
Episode 15: Efficacy Insights: Assessments by Principal Investigator and Subjects
Join us as we speak with France Wagner, Senior Director of Operational Strategy at Innovaderm, in our latest podcast episode. With over 15 years of experience in the CRO industry, France shares her insights on the complexities of efficacy assessments, focusing on data capture of clinical outcome assessments (COAs), the debate between paper and electronic methods, and measuring compliance for patient-reported outcomes (PROs) at home. Do not miss this enlightening discussion. Listen now.
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1 year ago
13 minutes 6 seconds

Phase Forward
In this episode, Isabel Dorion, Senior Director of Clinical Operations at Indero, shares expert insights on the critical role of Clinical Research Associates (CRAs) in ensuring trial quality and patient safety. Explore key strategies for effective CRA oversight and discover how quality reviews and adaptive risk-based monitoring enhance compliance and data integrity. Tune in for practical guidance on maintaining excellence in clinical monitoring and elevating trial outcomes.