Access to Novel Medical Products with Dr. Alison Bateman-House
Clinical Trial Podcast | Conversations with Clinical Research Experts
Release Date: 11/05/2023
Best Practices for Clinical Trial Budgeting
Clinical Trial Podcast | Conversations with Clinical Research Experts
Clinical trial budgeting remains one of the biggest bottlenecks in study startups, driving delays, rework, and frustration across sponsors, CROs, and research sites. In this episode of the Clinical Trial Podcast, recorded live at Research Revolution, a clinical research conference hosted by Florence Healthcare, we take a hard look at why clinical trial budget negotiations continue to break down—and what experienced operators are doing differently. This conversation brings together sponsor, site, and consultant perspectives to unpack the real drivers of delay, including slow escalation...
info_outline
Risk Based Monitoring in Clinical Trials with Artem Andrianov
Clinical Trial Podcast | Conversations with Clinical Research Experts
Risk-based monitoring has been discussed in clinical research for more than a decade, yet many organizations still struggle to implement it in a meaningful and effective way. In this episode of the Clinical Trial Podcast, we sit down with Dr. Artem Andrianov, a leading expert in clinical data quality and risk-based quality management, to unpack what risk-based monitoring really means in today’s regulatory landscape. Artem has over 25 years of experience in the pharmaceutical industry and is the CEO and cofounder of Cyntegrity a company that specializes in data driven risk management...
info_outline
Leading a Clinical Research Organization in the European Union with Dr. Philip Raeth
Clinical Trial Podcast | Conversations with Clinical Research Experts
In this episode of the Clinical Trial Podcast, host Kunal Sampat sits down with Dr. Philip Räth, Managing Director of Palleos Healthcare, to discuss leading Clinical Research Organization (CRO) in the European Union (EU). Managing a Clinical Research Organization is far more than project oversight. CRO leaders juggle sponsor expectations, site relationships, internal talent, regulatory demands, and profitability. A strong CRO partner can jumpstart a clinical trial for industry or academic sponsors that have limited infrastructure. A mismatched CRO, on the other hand, can derail timelines, add...
info_outline
Sponsor, Site, and Technology Vendor Collaboration with Mike Wenger
Clinical Trial Podcast | Conversations with Clinical Research Experts
To get more insights about clinical research technology from a vendor’s perspective, I invited Mike Wenger on the Clinical Trial Podcast. Mike Wenger is a software developer with over 15 years of experience creating innovative solutions in clinical research. At the Michael J. Fox Foundation for Parkinson’s Research, he worked to connect Parkinson’s patients with clinical studies. He later developed Citeline Connect, bridging patient recruitment companies with pharmaceutical organizations, and founded VersaTrial to streamline clinical trial site workflows. Mike is...
info_outline
Inspection Readiness with Donna Dorozinsky
Clinical Trial Podcast | Conversations with Clinical Research Experts
To discuss what inspection readiness entails, I invited Donna Dorozinsky, Founder & CEO of Just in Time GCP to the show. Donna is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. Her vast experiences dealing with small to large pharmaceutical companies, academic centers, regulatory agencies, clinical research organizations, and investigator sites provides her with the knowledge to assist research...
info_outline
Clinical Trials in Saudi Arabia with Dr. Majed Al Jeraisy
Clinical Trial Podcast | Conversations with Clinical Research Experts
Saudi Arabia’s modern healthcare system, diverse patient population, and research-savvy healthcare professionals make it a great place to conduct clinical trials. To learn more about the clinical trial requirements in Saudi Arabia, I invited Professor Majed Al Jeraisy on the show. Dr. Al Jeraisy is an Associate Professor of Pharmacy Practice, College of Pharmacy, King Saud Ben Abdulaziz University for Health Sciences and Pediatric Clinical Pharmacy Consultant in King Abdullah Specialized Children Hospital. He was appointed as the chairman of the research office at King Abdullah...
info_outline
Cardiology Clinical Trials with Dr. Gregg Stone
Clinical Trial Podcast | Conversations with Clinical Research Experts
To learn more about this important field of cardiovascular clinical research, I invited Dr. Gregg Stone on the podcast. Dr. Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY. He has served as the national or international principal investigator for more than 150 national and international multicenter randomized trials and studies (many of which have led to new device...
info_outline
Clinical Trial Insurance with Dan Fuld
Clinical Trial Podcast | Conversations with Clinical Research Experts
In this episode, you will learn about what type of insurance (if any) is needed to conduct a clinical trial. We also discuss different insurance provisions, choosing the right insurance partner, regulatory requirements that dictate insurance and much more. Dan is a seasoned insurance professional with 10+ years of underwriting and broking experience. Dan and his team also assist in the implementation of alternative risk mitigation strategies, and see themselves as strategic partners to those in the life science space. Dan graduated from the Katie School of Insurance at Illinois State...
info_outline
Diabetes Clinical Trials with Dr. Stayce Beck
Clinical Trial Podcast | Conversations with Clinical Research Experts
To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. on the podcast. Dr. Beck currently oversees clinical operations, clinical strategy and science, biometrics and human factors at Dexcom Inc, a leading manufacturer of continuous glucose monitors (CGMs) Prior to joining Dexcom, Dr. Beck worked at Food and Drug Administration for over ten years, spending time as a scientific and regulatory reviewer, a chief of the Diabetes Diagnostic Devices Branch, and Deputy Office Director of Personalized Medicine and...
info_outline
Access to Novel Medical Products with Dr. Alison Bateman-House
Clinical Trial Podcast | Conversations with Clinical Research Experts
Providing patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike. To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison Bateman-House, PhD, MPH, MA, an Assistant Professor in the Division of Medical Ethics at NYU Grossman School of Medicine. Dr. Bateman-House is co-chair of the Working Group on Compassionate...
info_outlineProviding patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike.
To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison Bateman-House, PhD, MPH, MA, an Assistant Professor in the Division of Medical Ethics at NYU Grossman School of Medicine.
Dr. Bateman-House is co-chair of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies ethical issues concerning access to investigational medical products and which consists of patient advocates, clinicians, members of industry, current and former FDA staffers, lawyers, and academics, among others.
She advises biopharmaceutical companies, patient advocacy organizations, governmental, and non-governmental entities about clinical trial design and non-trial access programs, and she serves as ethicist for numerous data safety monitoring boards overseeing clinical trials.
She has published and spoken extensively on non-trial access to investigational medical products, equity in clinical trials, individualized therapeutics, the history and ethics of using humans as research subjects, and public health ethics.
Sponsor(s):
This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com
This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at https://www.slopeclinical.com/