Podcasts

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.

Facilitating Decentralized Clinical Trials with the Direct-to-Patient Trial Strategy

On a global scale, Frontage Central Lab Business is assisting clients with their drug development needs across all clinical phases. In this podcast, the Frontage Central lab team will discuss some of the best practices to keep in mind when choosing a lab partner for PK/PD and routine/specialty central lab support.

What Strategies Should Pharma and Biotech Firms Take to Adapt to the Evolving Central Lab Landscape in Post-COVID Era 

This podcast will discuss:
•	How partnering with specialized research organizations can help identify large, diverse patient populations to facilitate clinical studies designed around the patient 
•	How advanced study planning and communication with regulators can ensure more successful execution of decentralized and hybrid clinical trials
•	The importance of the patient-physician dyad in implementing successful research studies  


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