Podcasts

Allucent’s Katy Moore, Pharm. D., R.Ph. President, Clinical Pharmacology Modeling and Simulation, offers insightful commentary for small and mid-sized biotechs developing scientific breakthroughs. Learn from Katy’s expertise how applying modeling and simulation can improve drug development and help bring new therapies to light.

Thinking Big for Small and Mid-Sized Biotechs: How Applying Modeling and Simulation Technologies Can Improve Drug Development

If the last few years have taught us anything, it’s that so much more can be achieved when all players in the life sciences and pharmaceutical industries work together in a truly collaborative way. The opportunity for the clinical development industry is to take what we have learned about how we can work together and use this to continue to drive progress. To strategically support clients, at ICON, this means partnering with sponsors in a way that goes beyond a traditional CRO. It means being a trusted partner.


The Evolving Relationship Between Sponsors and the Contract Research Organizations

Europe’s new Medical Devices Regulation (MDR) is four times longer than the previous Medical Device Directive, and it has raised the bar for clinical evaluations. It’s imperative that manufacturers proactively identify the gaps in their data and take the necessary steps to fill them — from pre-clinical through post-market. Many companies are unprepared for this task. Our guest, Dr. Kim van Noort, will walk us through some of the biggest challenges that MDR poses, and tell us how to overcome them. 

The MDR: Navigating Europe’s New Standard for Medical Device Safety

Sponsors and CROs have historically been responsible for ensuring full chain of custody for their own clinical supply even though the clinical supply is typically outside of their control.  It is the burden of the Sponsors and CROs to determine the most efficient way to do that. An eClinical Supply Chain Management platform provides Sponsors and CROs with the assurance that they are meeting their regulatory requirement of full chain of custody and more importantly ensures that all needed clinical supplies are available and all samples get where and when they are needed. 

The impact an eClinical Supply Chain Management platform can have on your next clinical trial

Overcoming Technology Challenges in Decentralized Clinical Trials 

First-in-human (FIH) is a critical milestone for companies pursuing medical device development. Medical device developers often experience great pressure to shorten timelines and get to the clinic. However, it is important to keep certain aspects top of mind to have a successful FIH clinical experience.

Key Considerations for Interventional Medical Devices Undergoing First-in-Human Studies

R&D growth from biotech and emerging biopharma companies is strong. With that comes a transformation of the end-to-end services needed to meet the strategic, clinical, and operational needs of these smaller companies. Join this podcast to learn about clinical development and outsourcing trends that emerged in 2021 and a discussion of what to expect in 2022.

Trends in Biotech Clinical Development Podcast

Making Every Connection Count-Powering Clinical Trials with the Right Connected Devices and Better Data

Kurt Mussina, MBA, president of Frenova Renal Research, explains how the site landscape is changing for clinical research. He has years of experience leading a global network of investigators, patients and data scientists involved in clinical studies. He brings a unique perspective to what the major problems in clinical research sites are, including private equity and industry consolidation. Refreshingly, he provides solutions Frenova is implementing that will promote better clinical research sites.

The Changing Landscape of Clinical Research Sites With Frenova Renal Research

A direct-to-patient (DtP) clinical trial design, where investigational medicinal products (IMP) and clinical supplies are shipped or delivered directly to patients, fits within a decentralized clinical trial (DCT) model. Although patients, sites, and sponsors can all benefit from this trial design, there are unique complexities to DtP trials, that can be managed with advanced technology. Learn about this trial strategy, the unique challenges, what the industry is doing to address these challenges and how technology can help facilitate adoption of this trial design.

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