Phase Forward

PMR, lupus, and emerging MOAs... Oh my! So much innovation at this month's mammoth rheumatology scientific congress, EULAR - the European Alliance of Associations for Rheumatology, in London, England. Join us in conversation with Ekaterina Radchenko, Senior Project Manager at Indero, who is experienced in multinational rheumatology studies. She shares her clinical operations viewpoint of EULAR 2026.

In this episode, Global Head of Clinical Trial Delivery Diane Leclerc explores how ground‑level insight shapes strategy, accelerates decisions, and strengthens team accountability. She unpacks practical ways organizations can empower operational teams to influence direction, innovate, and adapt during leadership transitions. Through real examples from clinical research, Diane highlights how local expertise drives expansion success, why emergent strategies matter, and how proactive risk management builds trust across sites, sponsors, and patients. Listeners will gain actionable guidance on building resilient teams, navigating change, and sustaining operational excellence in fast‑moving environments.

In this episode, Esther Sanchez, Associate Director of the Global Start-Up Unit at Indero, shares insights from her 24+ years in clinical research. She breaks down why a strong startup unit is critical to clinical trial success, how resilient “front‑line” teams protect timelines, and the essential checks every company should implement to avoid costly delays. Esther also highlights common challenges in regulatory submissions, site activation, and cross-functional alignment, offering practical strategies to strengthen collaboration, accountability, and risk management. Tune in for actionable guidance to improve startup efficiency and elevate trial outcomes.

In this episode of Phase Forward, Raelle Kennedy Brown—brand marketing consultant, patient advocate, and founder of Woke Within (Skin), shares how storytelling can transform patient advocacy. We discuss building trust in clinical trials, designing research that reflects diversity, and addressing the unique challenges faced by patients with eczema, especially those with melanated skin. Raelle’s insights reveal why inclusive representation and patient voices are essential to improving care.

This episode explores the future of skin biomarkers. Featuring insights from Simon Grant, CEO of Ascilion, and Théo Boyer, Senior Project Coordinator at Indero, the episode examines how dermal interstitial fluid (d-ISF) could revolutionize dermatology. Our guests illuminate the potential of ISF sampling, paving the way for more personalized and innovative approaches to care.

In this episode of Phase Forward, Siow Bee Seu, Director of Clinical Operations for APAC at Indero, shares her perspective on the evolving clinical trial landscape across the APAC region. With nearly 2 decades of experience in clinical research, she offers valuable insights into the strategic importance of APAC in global trials. Drawing from her expertise in project operations, regulatory strategy, and team leadership, Siow discusses how clinical trial approaches must adapt to the unique contexts of individual countries while navigating the region’s complex regulatory environment. Her reflections provide a practical look at managing trials in one of the world’s most dynamic regions.

In this episode of Phase Forward, Hubert Godziatkowski, founder of the Polish Atopic Disease Association (PTCA), shares how patient organizations can reshape clinical trials. With over 800,000 people in Poland affected by atopic dermatitis, PTCA is working to improve clarity in consent forms, promote ethical oversight, and build trust between sponsors and patients. The conversation explores PTCA's review of consent forms, the importance of early collaboration, and the role of advocacy groups in improving recruitment and trial accessibility.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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!

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.

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.

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.

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.

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.

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.

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.

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.

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.

Join us on Phase Forward as Éric Hardy, Senior Director in Biometrics at Innovaderm, dives into the critical role of system integration in clinical trials. With 27 years of experience, Éric discusses the significance, benefits, and challenges of integrating various platforms to streamline data management and enhance trial efficiency. Do not miss this insightful episode.

Join us for a special episode, live from the 2024 EADV in Amsterdam. We welcome Pedro Rosés Diaz de Rada, Director of Project Management at Innovaderm, who brings over 20 years of experience in the pharmaceutical and CRO environment. Pedro is renowned for his leadership and expertise in global clinical trial management, complex portfolio delivery, and achieving project objectives. This episodes explores the power of patient recruitment, highlighting patient-centric approaches, and the latest innovations in the field.

Join us on Phase Forward as we welcome Janet Overvelde, Senior Director of Project Management at Innovaderm Research, a vanguard in clinical research productivity. Dive into an insightful discussion on the role of rater training in clinical trials and its profound impact on the integrity and success of research outcomes. Do not miss this deep dive into a topic that shapes the efficacy and future of clinical studies. Tune in to enrich your understanding and stay ahead in the field of clinical research.

We are thrilled to host Kyle Given, Innovaderm's VP of Clinical Operations. With a wealth of 20 years of industry experience, Kyle has honed his expertise in clinical operations, central data monitoring, clinical trial management, and clinical systems. He brings this wealth of knowledge to our discussion on the role of clinical research associates (CRA) in clinical projects. Join us as we explore the evolving skill set of CRAs, underscore the importance of specialized training, and unravel the intricate dynamics of CRA-site relationships.

In this enlightening episode, we are joined by Dr. Jasmina Jankicevic, the Chief Medical Officer of Innovaderm. Dr. Jankicevic is a globally recognized authority in the field of dermatology drug development, with her extensive experience spanning clinical trials and regulatory approvals. In this episode, we dive into the world of gene therapy. We will explore how gene therapy could revolutionize the field of dermatology, discuss the impact of stem cell therapy on dermatological treatments, and address the critical challenges that need to be considered when investigating gene therapy.

We are joined by Jason Shuris, Chief Business Officer at Innovaderm. With 25 years of experience in healthcare and life sciences, Jason shares his insights on the advantages of niche CROs. The episode covers his deep scientific knowledge, strategic trial expertise, and understanding of disease-related endpoints. Tune in for this enlightening conversation!

Welcome to our enlightening podcast episode featuring Mounia Lahjou, a seasoned project director at Innovaderm. Leveraging her extensive experience in the pharmaceutical industry, we will dive into the insights gained from Phase 3 clinical trials. We will explore the importance of comprehensive documentation, adherence to process compliance, and the pursuit of process improvement. Join us as we navigate trial management complexities, learning from Mounia’s insights to enhance your team and company’s performance. Tune in for this enriching experience.

In this episode, we are honored to welcome Ana Palijan, the esteemed Director of Early Phase and Translation Research at Innovaderm. Our journey takes us into the complex realm of early phase trial study designs. We start by demystifying the distinct features that set apart early and late phase trials. Next, we turn our attention to the role of data quality in early phase clinical research and its far-reaching implications on study results. We then delve into the unique dermatology techniques utilized in early phase trials and their importance. Embark on this captivating exploration with us alongside Ana Palijan!

Join us in this episode as we welcome Dr. Robert Bissonnette, the Founder and CEO of Innovaderm. We will explore the fascinating world of placebo response rates in atopic dermatitis, discussing key considerations, strategies to mitigate placebo response, and interpreting higher-than-expected rates of placebo responses. Do not miss this chance to learn from a dermatology research pioneer.

Join us in our latest episode as we look into the intricate world of clinical research with our esteemed guest, Valerie Paolella, Associate Director in Clinical Trial Management at Innovaderm. In this enlightening episode, we explore the complex topic of risk-based monitoring (RBM), a critical component in clinical trials. Our conversation begins by exploring the various forms of clinical monitoring, each with its unique characteristics and applications. We then navigate through the best practices in RBM and discuss the challenges that arise, offering insights on how to effectively manage these hurdles. The discussion culminates with an in-depth look at the process of assembling the RBM A-Team, where we highlight the key roles and skills required for successful RBM implementation.

Join us for a special episode of our podcast, hosted by Janet Overvelde, Innovaderm’s Senior Director in Project Management, live from the 2024 AAD in San Diego, CA. Janet interviews Staci Ellis, the Vice President and Head of Regulatory Affairs at RegDev Inc., a seasoned leader with a wealth of experience in Regulatory Affairs. They explore the guidelines for a successful Investigational New Drug (IND) filing in the US, discussing early engagement, strategic planning, aligning dose data with FDA safety assessments, and the importance of compliant Chemistry, Manufacturing, and Controls (CMC). Do not miss this episode packed with expert advice and valuable insights.

We welcome Edith Siméon, Innovaderm’s Associate Director of Biostatistics, who brings over 20 years of industry experience. We dive into the critical role of estimands in clinical trials and data analysis, focusing on their purposes and requirements, cross-functional responsibility, and impact on statistical analyses. This episode promises to enlighten and inspire.

In this episode, Innovaderm’s Chief Operating Officer, Cedric Burg, an expert in clinical trial management delves into the significance of prior indication experience in clinical trials, focusing on site proficiency, protocol insight, and focused monitoring. Gain valuable insights from Cedric’s extensive experience in the field.

We welcome Innovaderm’s seasoned Project Director, Fadi Achkar, with more than 15 years of experience in the field. This episode covers the complexities of multicenter studies in AA. We explore how to account for patient AA severity during recruitment, the subjective nature of the Severity of Alopecia Tool (SALT) and the unmet needs in AA. Gain valuable insights from Fadi’s extensive experience in the field.