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.