The Next Phase: Exploring Innovation in Clinical Trials

The only way to drive innovation and improve the efficiency of the sector is to create alliances and be collaborative; to be able to do more together than separately with patient-centered objectives.In this episode, we discuss the challenges and innovations that are transforming the landscape of drug development and clinical trials, and how we can grow in a market with so many players. Carlos Orantes, CEO of Alconza Clinical Research, shares his insights from over 30 years of experience in the industry, and dives into the importance of collaboration and teamwork to address all the industry challenges, emphasizing on the main objective: An approach centered on the patient.Join us as we discuss:How innovation in technology is playing an important role in streamlining processes and the positive impact on patient care, experience, participation and diversityInsights and advice for the future of clinical trials, focusing on the impact of the patients and sites while removing barriers and finding opportunities around the worldThe role of FDA guidelines in driving innovation, particularly in diversity and decentralizationThe significance of continuous learning and mentorship in staying innovative

Innovation that makes a difference is driven by the people that it impacts the most and is focused on value propositions.In today's episode, we delve into the pivotal shift towards digital over the past seven years. Matt Smith, VP of Research Site Development at Slope, emphasizes the necessity of streamlining research processes and making the lives of those involved in research easier. Matt explains how efficiency, standardization, and interoperability emerge as focal points for improvement, with an eye on AI to revolutionize processes and provide a free platform for research organizations.Join as we discuss:Integrating technology into the workflow of research sites to streamline processes and improve efficiency for sponsors and vendorsInnovation driven by the needs of research sites to reduce risk and save time in clinical trialsHow collaborative platforms like Slope can simplify technology usage across trials and empower research sites, sponsors, & vendors

Our latest guest is Sandy Smith, Senior VP of Clinical Solutions and Strategic Partnerships at WCG, a company that connects sponsors, CROs, sites, and participants to deliver efficient, safe and impactful clinical research. In this conversation, Sandy shares insights into her background as an advanced practice nurse and how she landed 3 years ago at WCG where she leads Clinical Solutions and Strategic Partnership to solve some of the biggest challenges in research. In this talk, Sandy will touch on her role connecting diverse stakeholders (sites, sponsors, CROs), while advocating for the patient’s voice. She will emphasize the convergence of clinical care and research in oncology, while getting us excited about the future of innovation. Join as we discuss:Challenges posed by technology complexity, resourcing issues, and the overall increased complexity of modern trialsThe importance of patient-specific data to reduce trial timelines without compromising qualityThe potential of AI and machine learning in identifying optimal sites, patient identification, and recruitment

Accreditation and standardization are the keys to driving positive change in the clinical research industry, leaving a lasting legacy and making strides toward global collaboration.Today we’re joined by Jacqueline Johnson North, CEO and Co-Founder of GCSA. The Global Clinical Site Assessment Standard enables clinical research sites, CROs, and sponsors to work synergistically, while fostering a truly patient-centric system. We discuss the development of a certification standard for clinical research sites, the 7-module approach of their assessment, and the impact on the industry. Join as we discuss:The role of GCSA in overcoming barriers and building a patient-centric systemThe value of certification standards in driving positive change in the industryThe need for collaboration and innovation to improve the efficiency and effectiveness of clinical research

The success of any piece of software or solution = the quality of the solution x the buy-in and adoption of that solution.In today’s episode, our guest Dave Hine Senior Director of Sales Engineering at Greenphire, shares his unique journey from aerospace engineering to the clinical trial industry. The conversation highlights the importance of patient-centricity, explores Greenphire's innovative solutions, and delves into the challenges of patient enrollment. Dave shares insights on industry trends, has a clear vision for the future of clinical trials, and offers valuable advice for those entering the field. Join as we discuss:The crucial intersection of technology and patient-centricity in the clinical trial industryAppropriate expectation setting and addressing feasibility issues to increase patient enrollmentProactive approaches to address challenges and enhance the overall patient experience

A unified system that enhances patient care, improves outcomes, and advances research to ensure the right patients receive the right therapies…That’s the goal.Our latest guest, Melisa Tucker, is a healthcare industry expert with a significant background in healthcare innovation and data utilization. She is currently serving as Head of Research Evidence Generation Program at Verily. Melisa discusses her journey in the clinical research landscape, emphasizing the importance of working with great people and staying curious to seize opportunities for personal and professional growth. The episode delves into the evolving receptiveness of the healthcare industry to technology, particularly in the context of unstructured data and AI. Melisa envisions a future where a single, comprehensive source of healthcare data can power better patient care and transform clinical research. The episode provides insights into the ongoing innovations and potential impact in healthcare technology and research.Join as we discuss:The role of technology and innovation in clinical researchReceptiveness of the healthcare industry to technologyPotential of unstructured data and AI in healthcareThe vision for a unified source of healthcare dataImportance of working with inspiring individualsOpportunities for career growth in the healthcare industry

By connecting individuals to roles and organizations that require their skills, we can accelerate medical progress, leading to longer and healthier lives. Thus, more birthdays.In today’s episode, we’re excited to be joined by Lauren Stockwell, Director of Outreach and Engagement for Clinical Research Fastrack. Lauren and I discuss the evolving landscape of talent in clinical research and the importance of opening doors to candidates with non-traditional backgrounds. We break down the skills needed in the industry today and what the future might hold. Lauren shares insights into the Clinical Research Fastrack program and how it's helping to fill the talent gap in the industry. Whether you're a candidate looking to enter the field or a leader seeking to hire, Lauren provides valuable insights and ways to connect with the program. Join us in this engaging conversation, and let's shape the future of clinical research together.Join as we discuss:Unconventional paths in clinical researchSuccessful skills and qualities needed in a clinical research professionalThe desire to see more diversity in the clinical research workforce and a more inclusive approach to hiringThe positive impact of taking a chance on individuals and recognizing their potential for growth in the industry

The realm of clinical research holds boundless opportunities.Our latest guest, Julia Sundari, Senior Director of Clinical Design and Analytics at IQVIA, joins us with 30 intentional and passionate years in the industry, all beginning with participation in a research trial for NASA. In this episode we dive deep into innovative approaches such as risk-based monitoring, remote monitoring, and systems interoperability. She shares her experiences leading a global team of women, and sheds light on the importance of user-centered design and creating a seamless experience for both sites and subjects. Julia's insights on the future of trial design and the role of technology in enhancing efficiency and sustainability are truly eye-opening. Join us as we discuss:Latest trends and opportunities in the ever-evolving landscape of clinical trialsThe need for clinical trials to reflect the diversity of the global human populationPotential for single data entry and integration between EDC and EMR systemsAIML's potential in revolutionizing clinical research

Building better protocols — As we think about DCTs, site capabilities, diversity, equity & inclusion, and going global in research, it comes down to how protocol is designed and then ultimately, how regulatory agencies are going to view and deliver on these promises. Our latest guest Douglas Reichgott, Executive Director of Clinical Research at Beth Israel Deaconess Medical Center, shares his insights on the industry, reflecting on the changes he’s witnessed over the past 25 years and sharing his desires for the future in clinical research. Join us as we discuss;Benefits and challenges of DCTsThe future of technology integration: streamlining systems and data Empathy in research and the importance of putting people first Soft skills for success in the field

The ultimate goal in the Clinical Research space is to make trials more accessible to the broader population. Inevitably, the industry has been struggling with enrollment and recruitment. In this episode, our guest Darcy Forman, Chief Delivery Officer at Science 37, shares insight into the implications of increasing clinical research accessibility, from increasing awareness among the general population to testing medications within the populations that will ultimately benefit from the treatments.Join us as we discuss:Pros and cons of transitioning from the pharmaceutical industry to the tech vendor/business side Pressing challenges of enrollment and recruitment in clinical trialsHurdles to providing global scalable execution

Clinical research is moving faster than ever. With developments in technology, distributed trials and accelerated research opportunities, the way we treat patients is adapting.According to Lauren Chang, VP of Strategic Growth at Clinical Research Fastrack, working in the evolving, accelerated world of clinical research takes a particular skillset — something she’s dedicated herself to helping cultivate in her current role. Join us as we discuss:The value of tech skills in any clinical practiceDeveloping professional relationships and seeking mentorshipHard and soft skills necessary for entering clinical research

The focus on diversity, equity and inclusion (DEI) is gaining momentum across pharma and clinical trial environments. But, often, initiatives are difficult to enact within existing industry infrastructures. To truly embrace DEI in clinical trials, clinical trials must enter community clinics — many of which are not quite ready to enter the trials space.While the challenge is no small feat, our latest guest Jennifer Kim, Assistant Professor at Tufts University School of Dental Medicine is out to change the world of pharma and clinical trials by increasing access and diversity. According to her, DEI efforts take more than patient diversity — they require attention to how we design research, drug development, team dynamics and much more.Join us as we discuss;Readying community clinics for clinical trials to expand research and engagementCombatting community misconceptions and embracing DCT opportunities The role of regulatory agencies in driving change

As a college student in Nashville, our guest answered a radio ad to participate in a clinical trial and was offered a part-time job filing regulatory documents and pushing papers.Now she’s a leader in the world of clinical biotechnology research and early-phase oncological development.Suzanne Kincaid, Chief Operating Officer at Aperio Clinical Outcomes, is excited to witness inspiring innovation and the rise of platforms that increase research capacity and offer vital centralized monitoring and analytics.Join us as we discuss:How high-tech site solutions improve workflow and allow researchers to spot crucial signals much earlierReal-time visibility supports frontier sites and helps CRAs focus on building relationshipsThe importance of decentralized and remote-enabled trials for increasing diversity, accessibility, and representationWhy networking and mentorship are critical for finding success and getting more talent into the research field

Technology has streamlined systems, eased technical processes and accelerated innovation, especially in recent years. But what’s to come is perhaps more exciting. Technology and innovation is set to open the world of clinical trials to be more accessible to each and every person around the world.On this episode, we’re joined by Susan Mauermann, Start-up Specialist and Jennifer Brown, Manager of Research Operations Quality & Effectiveness at Medical College of Wisconsin, experts who have first-hand experience in clinical trials from front to end. Join us as we discuss:Trends and operational hurdles in clinical trial spaces Expanding patient access to clinical trialsEnsuring investigators and sites are equipped with tools, too

Whether we like it or not, technology is becoming a part of our daily lives. This is no different in the clinical research industry as well. Our guest today joins us to talk about how innovation in clinical research starts with technology. Tyler Payne is the Director of Conduct Enablement, Clinical Trial Services at CVS Health. In this episode, Tyler gives insights into the clinical research industry and where things are headed in the next few years. Join us as we discuss:How Tyler got his start in the healthcare industry Some significant initiatives coming in the next few years that are going to disrupt how we think about clinical researchThe types of technology that facilitate optimization at scale while maintaining some level of personalization. Advice for people who want to get involved in clinical research

The clinical research industry is rapidly evolving, from virtual trials to precision medicine, with new trends emerging. Our guest today has over 20 years of clinical research experience and a passion for patient care and developing teams that thrive. Kimberly Jenkins is the Research Administrator at Cleveland Clinic, a multispecialty academic medical center that integrates clinical and hospital care with research and education. In this episode, Kimberly shares her clinical research journey and the direction of the industry. Join us as we discuss:Trends that are coming in the clinical research industry The types of skills and capabilities that Kimberly looks for when building a teamHow we can achieve more diversity, equity, and inclusion in the clinical trial marketHow to keep the human connection with the growing changes in medical technology

When you’re halfway around the world and you need to make a purchase, it’s as easy as pulling a plastic card out of your wallet and swiping. Why can’t we have the same simplicity with our healthcare data?  The answer is complex, according to Arlen Meyers, President and CEO of the Society of Physician Entrepreneurs. A medical doctor and a startup consultant, Dr. Meyers, discusses all the ways we can work toward ethical data exchange and improve on what he calls our “sick care system.”  Join us as we discuss:What interoperability for healthcare and clinical trial data meansBarriers to interoperabilityWhy physicians and business people must work together on data exchangeHow owning their data can empower patients in clinical trialsWhy technology is essential for data exchange between physicians, patients, and healthcare organizations

You wouldn’t take a drug if you didn’t know if it was going to help you. It might surprise you to hear millions of people do this every day. Not because they don’t care or don’t want to know, but because they live in a system that wasn’t built for them.  This is the reality for underrepresented communities and racial and ethnic minorities who have been all-but-locked-out of the clinical trial process.  Tiffany Whitlow, Co-Founder & Chief Development Officer at Acclinate, shares her insights about the depth of inequity in the clinical trials system and how we can fix it.  Join us as we discuss:How Tiffany co-founded a company made to bring DEI back into clinical trialsThe surprising statistics surrounding inequity in healthcareHow Acclinate is changing the system to bring clinical trials to those who need them mostWhat pharmaceutical sponsors and research sites need to do to increase clinical trial equity

Capping off season 2 of “The Next Phase,” this episode looks back at the insights and key learnings gleaned from conversations with industry experts as they’ve unpacked the innovations driving clinical research in a post-pandemic economy. Blake is joined by Florence Healthcare's co-founder and CEO Ryan Jones to discuss what’s happening in clinical research today and the innovations Ryan anticipates will have the biggest impact on the industry.

This episode dives into epidemiology and real-world evidence, as host Blake Adams and Paul Petraro, Global Head of Real World Evidence, Data Analytics, Value Evidence and Outcomes for Boehringer Ingelheim explore the evolution of real-world data, its use cases, and the need for trust and transparency when leveraging information across the clinical research industry.