PharmaTalkRadio

Unlocking Unstructured Data with AI for Optimized Protocol Development

In this podcast, Mike Eckrote, SVP, Strategic Solutions at Advarra, talks about how artificial intelligence is being used to pull insights out of structured and unstructured data sources to help sponsors avoid protocol amendments and delays.   More specifically, Mike discusses:   * How Advarra is leveraging past IRB data sources to identify common causes of site burden, study delays and amendments  * What questions sponsors should be asking of AI vendors, to pick the correct partner  * How sponsors have responded to the insights surfaced by this technology   * Why sponsors must adapt to a flexibility mindset in order to truly make changes with downstream impact

Bridging Access Gaps: Sponsor-Led Enablement of Research-Naïve Sites to Expand Patient Reach

Tapping into research-naïve sites offers a strategic opportunity to expand patient access. That’s exactly what Endo did when faced with challenges activating sites for their orthopedic study. This case study shares how Endo enabled a new site through hands-on mentorship, infrastructure support, and trust-building— resulting in sustainable partnerships and broader patient reach. * How naïve sites can help address access and enrollment bottlenecks * How to support inexperienced sites with the right sponsor-led infrastructure * What it takes to shift internal expectations and foster lasting site partnerships Speakers: Carrie Lewis Executive Director, Clinical Program Optimization, Endo Suzy Montayne Site Relationship Manager, Endo Terry Oehler, DPM Founder & CEO, Colorado Clinical Research

Building Trust-Driven Partnerships: AstraZeneca’s Concierge Approach to Accelerating Site Activation and Enrollment

AstraZeneca’s US Site Engagement Leads will share how they are reimagining sponsor-site relationships through a trust-first, high-engagement operating model that emphasizes flexibility, responsiveness, and co-creation. This session will showcase how their embedded approach to collaboration has enabled faster site activation, stronger recruitment performance, and improved data delivery—backed by real metrics and lessons learned from a three-year initiative. Key topics include: * How continuous site feedback loops and flexibility with SOPs improved startup timelines * Metrics from a recent study showing impact: 30% faster budget negotiations, 27% reduced activation times, 68% of recruitment from 42% of sites * Tools and tactics used to build consistency, transparency, and trust across studies * Lessons learned and how the program has scaled globally Speakers: Shannon Edwards Site Engagement Lead, AstraZeneca Tina Nghiem Site Engagement Lead, AstraZeneca

Eli Lilly on Site Enablement: Co-Designing Solutions with Sites

A case study highlighting how Eli Lilly partnered with clinical sites to co-design practical, site-centric solutions that enhanced trial execution and operational efficiency. Fireside Guest: Shafaat Ali Khan Clinical Research Lead (CRL) Director – Investigator Engagement, Eli Lilly & Co Moderator: Jyoti Angal, PhD Director, Clinical Research, Avera McKennan Hospital & University Health Center

What a Strategic Partnership Looks Like in Practice: Inside the Takeda–Basil Collaboration That Delivered Tenfold Enrollment

This case study highlights how Basil Clinical Research and Takeda’s first-time partnership became the top global recruiter, exceeding enrollment goals by tenfold through proactive assessments, early collaboration, and inclusive design. Learn how Takeda’s shift from transactional to strategic, long-term partnerships made this success possible. * Identifying and partnering with highpotential sites * Incorporating site feedback and early collaboration to improve trial execution * Building trust and fostering long-term site relationships * Key actions that led to exceptional enrollment and trial efficiency Speakers: Brandon Doyle, MBA Associate Director, Study Site Engagement, Takeda  Mark Rapp, MD Principal Investigator, Basil Clinical Research