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Aligning AI Use Clinical Trials With FDA And EMA Expectations

By Jessica Cordes - May 7, 2026

Guest Column | May 7, 2026 Aligning AI Use Clinical Trials With FDA And EMA Expectations By Jessica Cordes, senior consultant, Clinical Excellence GmbH Even when strategic decisions, vendors, and data science teams sit in the United States, the moment

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I'm Jessica Cordes

I am a professional in Clinical Operations dedicated to helping you as a small Company

to conduct successful First-In-Human Clinical Trials and develop your Organization to abhiebe your Drug Development Goals.

With a Master's degree in Molecular Life Science and over 15 years of experience in Clinical Trials, whereas over 12 years in Oncology and

over 6 years in Cell and Gene Therapy, I have honed my skills in areas such as

Protocol Design, Site Selection and Site Feasibility, Patient Recruitment, as well as

Organizational Development and Leadership.

Aligning AI Use Clinical Trials With FDA And EMA Expectations

07.05.2026

Clinical Leader

FDA’s Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs

04.03.2026

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