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Clarity, Focus, and What Comes Next

Thank you for being part of the Ascendia Clinical community. We’re grateful to work alongside sponsors, partners, and industry leaders who share a commitment to thoughtful execution, clear decision-making, and progress across clinical development. Your engagement and perspective continue to shape the conversations we focus on and the insights we share.

In this edition of our newsletter, we’ll highlight updates across several areas of our work. In Community News, we reflect on timely industry moments and conversations shaping the clinical landscape. Our Team Spotlight shares perspectives from the people and partnerships driving our work forward.

Over the past quarter, our team has been navigating real-world challenges alongside our peers—from weather disruptions that tested operational resilience to in-person discussions at SCOPE 365 in Florida.

Looking ahead, we’re introducing Ascendia FLEX—a flexible, tiered approach to clinical support designed to deliver the right expertise at the right time, without unnecessary complexity or long-term overhead. In parallel, we’re advancing our AI work from strategic thinking into practical, real-time application within clinical operations.

Thank you for staying connected and for being part of these conversations. We look forward to continuing the work ahead—together.

Ascendia Clinical
In this newsletter
you can expect:
Community
News
Team Spotlight
The Clinical
Current
Making Q1
Count

Community News

Sponsors Re-Evaluating CRO and FSP Models

Across the industry, sponsors are re-evaluating traditional CRO and FSP engagement models. Rather than defaulting to large, all-encompassing partnerships, teams are increasingly prioritizing flexibility—bringing in the right expertise at the right moment to address specific operational, quality, or oversight needs.

This shift reflects a broader focus on impact over scale, with sponsors seeking experienced leadership that can adapt as studies evolve.

As trial complexity increases, many organizations are finding that targeted, flexible support models offer greater control and an efficient use of resources throughout the study lifecycle.

Ascendia FLEX™ was designed with this reality in mind—providing scalable, right-sized leadership and operational support aligned to each study’s specific needs and inflection points.

Collaborator Spotlight

Leesa Gentry is Chief Clinical Officer at RenovoRx, with nearly 30 years of experience leading clinical research across pharma, biotech, and CROs.

Having held senior roles at Evotec, PPD, OmnicareCR, and Otsuka, Leesa brings a rare, end-to-end perspective on trial execution.

We had the great honor of hosting Leesa on The Clinical Current podcast, where she shared practical insights sponsors can apply immediately.

The Clinical Current Podcast

In our latest episode of The Clinical Current, we sat down with Leesa Gentry for a practical conversation on trial execution and leadership.

Together, we explored what trial execution looks like beyond theory—how decisions actually get made under pressure, where operational friction shows up first, and why leadership and focus matter more than ever.

Up next, we’ll continue the discussion with a roundtable episode featuring QACV, exploring quality, oversight, and execution from multiple perspectives.

Making Q1 Count

If you’re responsible for protecting timelines, quality, and decision-making across a study, our recent three-part blog series was written with you in mind.

Making Q1 Count focuses on how sponsors can use the first quarter of the year to create clarity before pressure builds. The series explores practical ways to establish operational oversight early, identify risk while there is still time to act, and improve execution through proactive inspection readiness and smarter patient recruitment prescreening.

It concludes by reframing Q1 as a strategic decision window—one that allows you to prioritize what truly matters, align resources intentionally, and avoid reactive course correction later in the year.

The goal is simple: help you move into the rest of the year with more control, fewer surprises, and greater confidence in how your study is being run.

Thank you for reading!
ASCENDIA CLINICAL
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Ascendia Clinical delivers expert consulting solutions for the Biotechnology and Pharmaceutical industries, with a focus on integrity, collaboration, and results. Partner with us for tailored strategies that drive your success.

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