Blog Articles with Clinical Research Insights

FDA’s Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs

By Jessica Cordes - March 4, 2026

Guest Column | August 12, 2025 AI-Enhanced Clinical Project Management For Cell And Gene Therapy Clinical Trials By Jessica Cordes, senior consultant, Clinical Excellence GmbH The pace and complexity of clinical trials have accelerated significantly in recent years, particularly for

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Why The EU Biotech Act Matters To The U.S.: A Clinical Perspective

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Regulatory Pathways – With Real-Life Examples – For Successful CGT Clinical Trials

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AI-Enhanced Clinical Project Management For Cell And Gene Therapy Clinical Trials

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What Sponsors Must Know About Digital Systems And AI Compliance

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Everything To Know About Long-Term Data Collection For Cell And Gene Therapy Trials In The EU

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From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials

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.