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Navigating the tumultuous sea of inflammatory bowel disease (IBD) is no small feat, and Ariadna Maso of Sanno Health is our compass on this voyage. As the mastermind behind a company that's reshaping how we understand and manage gut health, Ari shares her intimate understanding of the patient's struggle, from the stinging uncertainty of diagnosis to the often overlooked psychological toll. Our conversation goes beyond the standard medication narrative and into the realm of holistic care, where anti-inflammatory diets and mental health support take center stage. Ari's insights into ongoing research illuminate a path for integrating these lifestyle modifications into patient care, offering a beacon of hope for those navigating these often-rough waters.
When it comes to personalizing patient care, digital biomarkers are the wayfinders charting a course through the previously uncharted territories of healthcare. But the journey is fraught with challenges: data diversity, operational hurdles, and the sheer volume of information from tools like wearables. In this episode, Ariadna navigates us through these operational storms, detailing how Sanno Health evolved from an app into a comprehensive platform that's not only tracking patient health but is actively engaging them in their treatment. We also probe into the stark disparities between industry perceptions of patient-centric care and the realities patients face, unveiling the transformative potential of incorporating patient feedback directly into clinical trial designs. Join us as we explore the diverse therapeutic landscapes that stand to benefit, including digestive health and the burgeoning realm of women's health, and the far-reaching implications of data-driven medical advancements.
Guest
Ariadna Masó
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This week we sit down with Erini Schlosser, CEO of Dyania Health, and chart the pioneering advancements in large language models within healthcare. This episode promises to reveal how the shift from simple entity recognition to sophisticated reasoning models has revolutionized drug discovery and the curation of electronic medical records, all while unpacking the challenges of data privacy, computational demands, and the hunt for specialized AI talent. Discover the fusion of technology and medicine where the collaborative potential for real-world data utilization in evidence-based studies emerges as a beacon for innovation amidst the complexities of modern clinical trials.
As we explore the parallels of AI training to medical education, you'll be enthralled by stories of AI models undergoing meticulous fine-tuning by our in-house physicians, echoing the rigorous journey of medical residents. Irene lifts the veil on her own path, which led from a lineage steeped in medicine, through the worlds of biochemistry and investment banking, to the groundbreaking integration of NLP into healthcare at Dyania Health. Our conversation shines a light on the future of automating clinical research, where AI not only answers but justifies with evidence, promising an unprecedented era in the management and interpretation of medical data. Tune in for an intimate look at the challenges overcome and the milestones achieved in teaching machines to navigate the intricacies of human health.
Guest:
Eirini Schlosser
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Saknas det avsnitt?
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Uncover how the seamless fusion of wearables with patient data is revolutionizing clinical trials in our latest conversation with Wessam Sonbol, the Founder and CEO of Delve Health. We navigate the transformation from cumbersome paper reporting to the sophisticated use of Patient Reported Outcomes and the continuous insights wearable technology offers. As we dissect the benefits and hurdles of this evolving data landscape, you’ll get an insider perspective on the intricacies of managing vast health metrics and setting benchmarks for impactful analysis. Plus, Wessam shares his knowledge on the reliability and strategic employment of wearables in clinical research, offering a glimpse into how these devices are altering the way we approach health monitoring.
In our discussion, the concept of 'wearables as a service' emerges, a trailblazing model crafted by Delve Health to elevate the clinical study experience for both patients and researchers. Wessam delves into the rigorous process of selecting wearables that align with trial goals, sharing how gadgets like Fitbits undergo efficacy evaluation. Be prepared to discover how innovations like automated compliance and concierge teams are mitigating study site burdens and boosting data quality. We also tackle the broader spectrum of challenges and advancements in clinical research, contrasting the swift advancements in wearable tech with the methodical progress of drug trials.
Join us to envision a future that prioritizes patient-centric care, reduced tool burden, and heightened automation, and don't miss Wessam's call to action for ongoing dialogue that aims to reshape the patient experience in the health and life sciences arena.
Guest:
Wessam Sonbol
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Unlock the secrets of clinical trial design with industry experts Pierre Colin and Boaz Adler as they join us for a deep dive into the early-stage planning that shapes the future of pharmaceuticals. They provide a look at the collaboration between clinicians, statisticians, and regulatory experts that's critical for determining the right patient populations, dosages, and study endpoints. With their guidance, we explore how statistical software and scenario planning play pivotal roles in estimating patient numbers, study durations, and costs, transforming clinical trial design into a fine art.
As we navigate through the evolution of statistical methods, our guests share their insights on the need for adaptability in clinical trial designs, especially in areas like oncology with unique endpoints such as overall survival. They spotlight the importance of cross-company collaborations and direct FDA discussions in driving innovations. The conversation also illuminates the ever-growing contributions of R-coding, a testament to the individuality of each study, allowing for customized and cutting-edge approaches to trial design.
To wrap up, we spotlight the dynamic landscape of drug development where biostatistics paves the way for groundbreaking designs. Our guests emphasize how feedback from scientific communities influences new methodologies, shifting the focus from traditional success measures to concepts like assurance and power in the promising zone. They also highlight the invaluable role of Bayesian designs, as exemplified by COVID-19 vaccine trials, in ethically accelerating drug development. As we close, remember that this field is ripe with diverse opportunities, and we invite you to reach out with your curiosities and follow-up questions.
Join us for this episode that's not just about the science of trials, but the transformation they undergo, ensuring the journey of drug development continues to revolutionize patient care.
Guests:
Pierre Colin: https://www.linkedin.com/in/pierre-colin-11139028/
Boaz Adler: https://www.linkedin.com/in/boazadler/
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Embark on a journey through the dynamic landscape of clinical trial outsourcing with Jason Gubb, the co-founder of ClinOps Clarity and Emergent Teams. As we navigate the historical shift from predominantly in-house operations to the intricate web of external partnerships, Jason sheds light on the critical decision-making processes that shape the pharmaceutical and biotech industries. Grapple with the challenges and opportunities presented by R&D budget constraints and learn how emerging biotech firms are steering through fluctuating funding currents. Discover a world where the right choice of vendors can make or break a clinical trial, and how companies balance the scales of internal project management and external collaboration.
With Jason's sage guidance, gleaned from his tenure at GSK and his entrepreneurial ventures, we dissect the artistry behind cultivating successful clinical trial partnerships. He shares insights on the transformative effects of smart decision-making and the vigour of challenging established practices while ensuring that every partnership is rooted in open communication and shared goals. Jason also illuminates the impact of a patient-focused ethos and addresses the nuances between co-creation and mere collaboration. So tune in to expand your understanding of the pivotal role that culture and relationships play in shaping the outcomes of clinical trials and to witness the emergence of alliances that are as resilient as they are innovative.
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In this conversation with Sam Whitaker, we delve into the pivotal issues faced by underrepresented groups—particularly those from lower-income backgrounds—highlighting the disparity in current demographics and the consequences it bears on the reliability of drug efficacy and safety data for diverse populations. We go beyond the surface to examine the complexities surrounding compensation for trial participants, debunking the myth that stipends serve as an incentive and instead revealing the net financial loss many endure. With Sam's expertise, we explore why the current compensation structures pose significant barriers for those in lower-income brackets.
Sam Whitaker's insights prompt us to question the ethical responsibilities of Institutional Review Boards (IRBs) in safeguarding participant welfare, particularly in terms of payment evaluation. The conversation scrutinizes the pressing need for standardized compensation practices, emphasizing the potential financial harm and barriers these present to willing participants. Our discussion raises awareness about the delicate balance between the pursuit of scientific knowledge and the imperative of ethical consideration in the realm of human testing.
Lastly, we shine a light on the legislative efforts aiming to dismantle the financial hurdles that deter diverse participation in clinical trials. Tax implications for low-income participants and the risks to their welfare benefits take center stage, with bipartisan support emerging as a beacon of hope in the push for reform. Sam shares the impactful work being done through Mural Health, including the Portrait Project, which seeks to humanize and democratize the clinical research process. Join us to understand how these initiatives are not just transforming patient involvement, but reshaping the landscape of clinical trials for the betterment of all.
Guest:
Sam Whitaker
Mural Health
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This week we speak to Boaz Adler from Cytel's Software Division. This episode promises to illuminate the intricacies of trial design through the lens of Monte Carlo simulation, revealing how this potent approach crafts trials resilient to a myriad of scenarios. Boaz delves into the pivotal roles of interim monitoring and strategic market positioning post-trial, offering a masterclass in the art of clinical trial conception that withstands the test of uncertainty.
As we navigate the vast landscape of clinical trial simulation, the topic of scale takes center stage. The conversation orbits around pioneering software platforms like Solara and East, which are reshaping trial design by integrating a kaleidoscope of variables and uncertainties. This episode pulls back the curtain on the potential of cloud computing to revolutionize simulations, providing a glimpse into the future where clinical trials are executed with unparalleled speed and precision. With Boaz' expertise, we ponder the industry's readiness to trust probabilistic outcomes and how regulatory bodies are warming up to the simulation-based approaches that these software platforms enable.
Finally, we bridge the gap between biostatistics and market access, highlighting the increasing influence of health outcomes research on clinical trial design. The discourse delves into the balancing act of incorporating quality of life measures for regulatory and reimbursement decisions, the finesse required to blend standard software with bespoke coding, and the imperative of enhanced inter-departmental synergy. My own path to life sciences underscores the episode's reflective tone, leading to a broader examination of Cytel's extensive contributions to the field, from their roots in Monte Carlo simulation software to a comprehensive suite of services that spans the full spectrum of statistical programming and evidence-based research. Join us for this enlightening episode to gain an insider's perspective on the dynamic confluence of biostatistics and pharmaceutical innovation.
Guest:
Boaz Adler
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Ever wondered why the life sciences industry is stuck in redundant vendor qualification processes? Picture an organization where quality is designed rather than inspected. Yes, it's possible and we're about to paint that picture for you in this stimulating conversation with our guests, Dele Babalola and Rani Naik. They've got their fingers on the pulse of the GxP space and are ready to share their insights on the pressing need to evolve from redundant processes. Pay attention as Rani unfolds her unique vision for an agile, phase-appropriate quality organization.
Imagine a world where vendor qualification is not a daunting task but a streamlined process. We got you thinking, right? Dele and Rani join us to unravel this concept further. It's all about being proactive, focusing on effective oversight, and perhaps venturing into the world of pre-approved vendors. From discussing the role of certification bodies to emphasizing the significance of a proactive approach, we've got this topic well covered.
Enter the world of vendor management where challenges are like a complex puzzle waiting to be solved. This is where Dele and Rani's expertise shines as they shed light on transparency, collaboration, and the risk-based approach. Here's a plus - they also detail the potential value of remote audits and the importance of having an internal individual who can ensure clear process flow. As we wrap up, we can't help but yearn for a more innovative industry that's ready to take leaps. You won't want to miss this candid conversation.
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Get ready to learn about clinical trials operations from an expert. This episode is an opportunity to learn all about the essential aspects of managing such trials and the core role of contract research organizations (CROs) in the process. We have the privilege of introducing Becky Baggett, Associate Vice President of Project Delivery at Rho, who unravels the complexities of clinical trials for us. She not only lays out the distinct stages and components of a clinical trial but also enlightens us on the crucial collaboration between the sponsor and the CRO, the importance of clinical research sites, data management, and project management. She underscores the absolute necessity of establishing solid relationships, trust, and experience in this highly controlled and regulated field.
As we navigate further, we plunge into the thrilling and demanding world of technology in clinical trials. This part is a trove of information on how technology can streamline trials and why it's crucial to tailor technological applications to the specific needs of therapeutic areas. This episode is not just about information, but also about engaging in a thought-provoking discussion, where we examine the subtleties of conducting trials across different therapeutic areas. We end on a note of aspiration, echoing the collective wish for increased funding in the industry, which could potentially fast track more life-saving medications from lab to market.
Guest
Becky Baggett
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Ever wondered what goes into designing a modern, adaptable, and inclusive lab space? Join us as we uncover the intricacies of laboratory planning with architect and lab planning leader, Marilee Lloyd. Marilee takes us behind the scenes of designing new research labs, divulging the importance of flexibility, adaptability, and the use of modular benching. She sheds light on the unique challenges and considerations of modernizing older labs, while emphasizing the impact of thoughtful lab design on achieving clinical outcomes.
We also engage in a lively discussion on sustainable and inclusive lab design with our guest. Marilee's passion for diversity in the life sciences industry and her dedication to creating environmentally-friendly and welcoming lab spaces is truly inspiring. From reducing air changes and utilizing high-performance fume hoods to fostering inclusivity with elements of nature and thoughtful design, Merilee provides a unique perspective on lab planning.
Guest:
Marilee Lloyd
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Ever wondered about the science behind a simple cough? What if we told you that a cough is not as simple as it seems and AI technology could revolutionize how we perceive it? Come along as we host Dr. Peter Small, acoustic epidemiologist and Chief Medical Officer of Hyfe, who enlightens us on the complexity of measuring coughs in clinical trials. Hear how traditional cough assessment methods are falling short and the challenges the FDA faces when validating new cough-suppressing medications. Furthermore, we discuss the severe impact of chronic cough on individuals, exacerbated by the COVID-19 pandemic, and how acoustic AI offers a unobtrusive and privacy-preserving solution for cough counting.
Imagine a future where cough monitoring becomes as routine as step counting. In the second half of our chat, Peter shares insights on the potential of acoustic diagnostics in revolutionizing cough treatment. Hear about a promising digital therapeutic for chronic cough, designed to reduce cough frequency, and the scarcity of effective cough treatments in today's medical landscape. From wellness apps to dedicated watches and SDKs for various devices, we discuss different forms of cough recognition technology, setting the stage for a future where technology and healthcare converge in fascinating ways.
Guest:
Dr. Peter Small
Hyfe
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Join us in a conversation with Nechama Katan, as we investigate the world of generative AI in life sciences, a realm where technology meets business, and where Nechama, an expert in innovative data in the clinical space of life sciences, will guide us.
We're taking a deep dive into the ever-evolving realm of technology in life sciences. We'll take a look at the shift from standalone to integrated tools, and how generative AI is influencing the distribution of labor in life science companies. We'll also explore the potential uses of generative AI in data summarization, and how it could disrupt the traditional role of programmers in clinical trials. Nehamah will share her experiences with chat GPT, Amazon product reviews, Grammarly, and Databricks AI Assistant, shedding light on how generative AI is being implemented in clinical trials and data analysis.
Finally, we will explore technology's significant role in data analysis. Nechama envisions a future where data is readily accessible to everyone seeking answers. She believes generative AI can help us verify random facts and enhance exploratory data analysis. She'll also share insights on how providing the right context to AI can enhance our understanding of the data in front of us. Tune in for this insightful discussion and be sure to reach out to Nechama for any queries or assistance you may need with a complex problem.
Guest:
Nechama Katan
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What if a pharmaceutical company can be deconstructed and re-assembled in a new configuration? This is already happening in cell and gene therapy manufacturing. Join us for an enlightening conversation with Jason Bock, the founder and CEO of CTMC, who has been at the forefront of this intersection between clinical research and manufacturing. Discover the unique challenges of setting up a manufacturing network for autologous cell therapies and how this relationship between clinical and manufacturing sites differs from traditional methods. Jason shares his journey of moving to MD Anderson Cancer Center, setting up a biotech firm, and transforming the supply chain, thereby expediting product development.
Imagine the thrill of cell therapy advancements and the potential for cures in a single dose! Uncover how the trailblazing minds at CTMC and MD Anderson have submitted six INDs in the span of just 18 months. Half of these are MD Anderson invented therapies, while the rest are biotech invented products. Alongside these exciting developments, we also delve into the implications of such revolutionary treatments on the healthcare system. Understand the challenges that lay ahead in terms of making these potentially curative treatments widely accessible. Tune in for this riveting discussion on the transformation of healthcare, offering a glimpse into the future of medicine.
Guest:
Jason Bock
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How is the pharmaceutical and biotech industry changing in the current financial climate? Our guest today, Ryan Keane, founder and CEO of Korio, shines a bright light on these subjects and more. This discussion is an exploration of our current healthcare landscape, dissecting the challenges companies face as they introduce new technology, the sudden shift in the vendor landscape, and the unexpected destruction of value in biotech due to companies discarding or divesting their assets.
We don't just stop at the surface. Ryan takes us deep into the complexities of customizing Interactive Response Technology (IRT) systems in clinical trials, highlighting the crucial role of education for both buyers and industry employees. We tackle the challenges of communicating complex information to patients and the need for creating reproducible and scalable processes. The conversation veers into the often misunderstood realm of clinical trial supply, the need for a no-code environment, and the importance of having technologically savvy folks who comprehend all the elements.
Guest:
Ryan Keane
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Ready to lift the lid on the untapped potential of open-source technology in clinical trials? Strap in for a fascinating journey with our guest Lionel van Holle, the founder of Open Source PV. We'll unveil the transformative power of open-source tech in the life sciences industry, including its innate transparency, parallel development capabilities, and cost-effectiveness. Lionel shares insights into the diversity of SAS, R, and Python programmers involved in this field, revealing how the open-source revolution is just around the corner.
The collaboration between code and pharmacovigilance is changing the game, and we're excited to share this revelation with you. Tune in as we navigate the complexities of finding the right code packages and understand the nuances of search engine keywords. We also uncover the tremendous impact of the FDA's move towards open-source data and algorithms, highlighting the future of industry-wide collaborations. Concluding our discussion, we delve into the promise of machine learning and automation in medical writing, demonstrating how tech is poised to interpret data and create automated reports, potentially revolutionizing the way we see medical documentation. Join our enlightening conversation and discover the next frontier in life sciences.
Guest:
Lionel Van Holle
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Ever wondered how the healthcare industry can leverage the power of marketing? Join us as we unravel the mysteries of programmatic marketing with the CEO and founder of Doceree, HJ. He takes us through the innovative platform that reshapes how messages are targeted to healthcare professionals. From reaching physicians, nurses, and pharmacists with personalized messages to rolling out patient savings programs, the benefits are limitless. All while staying compliant with data privacy and security guidelines. Buckle up for a deep dive into the world of automated marketing as HJ shares how their multi-tenant model disrupts the traditional process of segmentation.
But that's not all. Shifting landscapes, we get a taste of global pharmaceutical markets with HJ, a physician turned advertising expert. Navigating the choppy waters of language barriers and siloed data, HJ emphasizes the importance of market understanding before making that leap. He delivers a raw, unfiltered view of his journey in the advertising space and the critical role of market feedback in propelling growth. Here's your chance to gain a fresh perspective on the intersection of healthcare, marketing, and technology.
Guest:
Harshit Jain
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Join us in a fascinating conversation with our special guests, Richard Nkulikiyinka, as we unravel how endpoints in trials are transforming and the significant role they play in determining trial efficiency. We also delve into innovations in oncology endpoints and discuss the challenges and opportunities in cardiovascular trials. Tune in as we explore the use of composite endpoints in heart failure trials and exciting functional endpoints that are potentially leading the way for approval studies.
We took a deep dive into the critical impacts of trial design and data collection on entire trial enterprises, emphasizing the importance of prospective validation. Richard shared intriguing insights about the changing landscape of trial design and its ripple effect on the industry. He gave an in-depth analysis of sodium-glucose co-transporter inhibitors and the revolutionary changes they brought to the standard of care through a series of trials. You wouldn't want to miss their take on the advantages of umbrella and basket trials and the essential role collaboration plays for their success.
In this riveting discussion, Richard also illuminated the transformative power of innovation and collaboration in clinical trials. We delved into the thrilling potential of cross-company collaboration in investigating the same patient population and the possible role of impartial brokers. Richard also sheds light on how AI and technological advancements could enhance clinical trial outcomes. Listen as they dissect the potential of AI in imaging, its role in streamlining assessment processes, offering real-time feedback, and reducing the burden on specialists. As we wrapped up, we examined how machine learning could make clinical trials more cost-effective by automating the adjudication of events in cardiovascular trials. This enlightening conversation is a treasure trove of insights into the dynamic world of clinical trials.
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Understand the complexities of clinical trial design from a seasoned expert. We speak to our esteemed guest, Richard Nkulikiyinka , a senior leader in clinical development. Richard illuminates the often-misunderstood world of trial design, from setting objectives and identifying target populations to the nitty-gritty like data collection, visit schedules, and maintaining quality. The spotlight shines on patient-centric approaches, as Richard persuasively argues for designing trials that are more patient-friendly without sacrificing quality.
As we go deeper into the conversation, we reveal the intriguing process of creating and accepting endpoints for various diseases. Richard presents a compelling case study of heart failure trials, debunking the notion that traditional endpoints are always the best fit. He illustrates how a novel endpoint for counting all hospitalizations was innovatively developed and accepted by health authorities — a process that holds potential for other diseases reducing exercise capacity.
But it's not all about the technicalities. We also underscore the crucial role of collaboration in developing endpoints. To illustrate this, Richard shares his experience charting the benefits of pre-competitive collaboration between industry partners, academic institutions, and health authorities. We also navigate the challenges of innovating clinical trials, discussing the constraints of mega trials and escalating costs, and the collective effort needed to accelerate the development of new therapies. Get ready to reimagine the future of clinical trials with this enlightening discussion!
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Join us as we talk to Pradeep Sacitharan, a serial dropout turned award-winning scientist. Starting life as a war refugee and working in London bars, Pradeep's life took a radical turn following a near-death experience, propelling him into the world of drug development. He navigates us through his fascinating journey in the biotech world, recounting his trials and triumphs in the field.
Ever considered that academia might be flawed? Pradeep exposes the cracks in the academic system, expressing the need to revamp the current structure and invest more in budding talent. He shares his unique approach to experimentation, emphasising the power of learning from rejections. As he delves into his own experiences, he offers valuable insights to help young researchers navigate the often daunting world of academia.
But Pradeep's insights don't stop at academia. He explores the relevance of practical learning, neurodiversity, and talent identification. Plus, he sheds light on the fascinating and often complex world of biotech funding, helping us understand the important details often overlooked. Pradeep's story is not just about his own journey, but it also serves as a guide for anyone looking to carve their own path in the world of science and beyond. Tune in and learn from his unique perspective on the changing landscape of biotech, academia, and talent management.
Guest:
Pradeep Sacitharan
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Ever imagined the immense potential that decentralized clinical trials (DCTs) could unlock for patients and sponsors? This week, we're going on a deep dive into the world of DCTs with our esteemed guest, Ewa Lindqvist, a trailblazer in this space. Brace yourself for an enlightening conversation about how DCTs are paving the way for increased access to new treatments and real-time data for physicians, all while slashing costs and inefficiencies.
Resistance to DCTs, stemming from technology fears and competency gaps, is a significant hurdle. However, our discussion with Ewa sheds light on how regulators have transformed into allies in this journey. We also unveil Thread, an innovative app poised to streamline DCTs, with its impressive capacity to monitor compliance, safety, efficacy, and much more. So, if you've been apprehensive about DCTs, it's time to shed those fears!
In our final segment, we touch on the pivotal role of convenience in clinical trials. Learn how Thread is leveraging technology to synchronize wearables and EDC data, thus driving efficient clinical trial processes. Also, we explore the integral role of patient advocacy organizations in ensuring DCTs are offered to patients. This conversation promises to revolutionize your understanding of clinical trials and the extraordinary potential of decentralization. Tune in and get ready to be amazed.
Guest: Ewa Lindqvist
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