Charting a Course Through Complexity in Clinical Trials - Part 1

Gut Feelings: Navigating Life with Crohn's, We're excited to announce the release of our latest episode of the Trial Trends™ Podcast! In this episode, our host, Libbi Rickenbacher shares a deeply personal conversation with her co-host, Kathleen Greenough. Kathleen shares her journey as a new patient with IBD, offering heartfelt insights into the challenges and triumphs she has experienced...thus far. Her story provides a unique and touching perspective that truly resonates. Through Kathleen's narrative, this episode beautifully highlights the transformative power of sharing personal experiences. Tune in now to join this inspiring conversation!

- How fully digitalized, real-time temperature monitoring through integration with Randomization and Trial Supply Management (RTSM), leads to better oversight, quicker decision-making, a reduction of human error and increased patient safety - Showcase the application of in-transit monitoring of a Highly Advanced, Personalized and temperature sensitive drug, requiring real-time tracking of temperature, light, tilt, and location - Showcase how automated real-time communication solutions between on-site logger technology and the RTSM system transform drug supply management and oversight, whilst reducing the administrative burden on site users

In this part 2, your host Libbi Rickenbacher and guest Siobhan McKenna-Power dive into the world of RTSM development, shedding light on the critical role of the sponsor-vendor partnership. Join them as they explore how prioritizing the patient experience throughout the RTSM development process is paramount. Libbi and Siobhan emphasize the significance of fostering a true partnership between sponsors and vendors, enabling a focus on the sites and ultimately, the patient, from inception to execution. Through collaboration, stakeholders can ensure that the design and implementation of RTSM systems align with the needs and experiences of those participating in clinical trials. Moreover, this episode delves into the crucial aspect of data security and management within RTSM development. Ensuring compliance with regulatory standards and safeguarding sensitive information are imperative in maintaining trust and integrity in clinical research.

In part 1 of this episode, Libbi and Siobhan delve into the escalating intricacies of clinical trials, shedding light on the challenges and solutions within the realm of Randomization and Trial Supply Management (RTSM) build for clinical trial protocols. As the pharmaceutical and biotech industries evolve, so does the demand for adaptive and nuanced approaches to address the growing complexity in trial designs. The conversation unfolds as they explore the delicate nuances involved in tailoring the RTSM build directly to the specific needs of the protocol. Siobhan, drawing from her extensive experience, emphasizes the critical role of having a proficient team of RTSM experts. Together, they dissect the importance of this expertise in supporting end-users and, ultimately, ensuring the well-being of patients throughout the clinical trial journey.

In this podcast, dive into the ever-evolving landscape of clinical trials as we reflect on the overall trends of 2023 and cast our gaze forward into 2024. Join our hosts as they dissect the latest methodologies, technological advancements, and regulatory shifts shaping the future of clinical research and explore what tomorrow may have in store.

The evolution of clinical trials has not been synonymous with the word simple. In the modern world of life sciences, clinical trials have hugely evolved and continue to rise and complexity, whether it's the IMP and treatments themselves, the way they are administered supply management algorithms or the actual protocol designs... the list goes on. Throughout the years, this rising complexity has been matched with advancements in technology to help quell its takeover. In today's episode, we will explore the evolution of randomization technologies and how modern RTSM systems have developed to help address the high degree of complexity found in today's clinical trials.

Blockchain has been a buzzword in the pharmaceutical industry for awhile now: at industry conferences and in the press. Other industries, like retail, have already implemented early forms of this technology within the larger scope of their processes. But when it comes to our industry, there's still an air of skepticism. This podcast explores the implications of blockchain technology within the pharmaceutical industry as a whole.

In the life sciences industry, we’ve seen regulators play a critical role in helping to pave the way for increased creativity in clinical trial designs. Yet, there are still questions on whether innovation and quality can truly coexist in clinical trials. This episode aims to tackle the "why" behind quality because the answer to this key question brings light to this important issue as clinical trial complexity continues to rise.

For a variety of reasons, some patients in clinical trials hit a "brick wall" in terms of treatment options. This often leads to a feeling of helplessness when trying to understand what the next steps might be. In this episode, Libbi Rickenbacher is joined by Brad Power, Founder of CancerHacker Lab to discuss what can be done to promote patient advocacy within individual patient experiences, and within the larger clinical trial landscape.