Why Protocol Complexity Is Slowing First Patient In – And How Small Sponsors Can Fix Start-Up Inefficiencies

by Jessica Cordes  - July 23, 2026

Guest Column | July 23, 2026

Why Protocol Complexity Is Slowing First Patient In – And How Small Sponsors Can Fix Start-Up Inefficiencies

By Jessica Cordes, senior consultant, Clinical Excellence GmbH

Clinical trial start-up inefficiencies are rarely caused by a single bottleneck. Yet when timelines slip, discussions often focus on individual delays such as contract negotiations, ethics approvals, or site activation. What is frequently overlooked is a more fundamental issue: the increasing complexity of clinical trial protocols and the way this complexity cascades across all start-up activities.

For small and emerging biotech companies, this issue is particularly critical. 

Please read the full Clinical Leader Article.

About the Author

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Jessica Cordes is Managing Director of Clinical Excellence GmbH. She has 15+ years in clinical operations and previously served as Head of Clinical Operations at Immatics Biotechnologies and Medigene Immunotherapies, leading first-in-human cell & gene therapy trials.

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