Guest Column | May 7, 2026 Aligning AI Use Clinical Trials With [Read article]
Clinical Leader
Jessica Cordes
Empowering Your Clinical Trials
with Expertise and Innovation.
Accelerate your Clinical Trial Success – even in the most Complex Environments with Cell and Gene Therapies.
You often face high-stakes challenges:
Struggling to meet patient recruitment targets Pressure to deliver high-quality data packages on time Gaps in GCP compliance and operational structure Teams needing practical training and support under tight timelines
At Clinical Excellence GmbH, I help you overcome these hurdles with strategic consulting, hands-on support, and targeted training – tailored to the unique demands of cell and gene therapy trials.
Hi, I'm Jessica.
I am a Clinical Operations Professional with over 15 years of experience in Clinical Trials, including more than 12 years in Oncology and over 6 years in Cell and Gene Therapy.
With a background in Molecular Life Sciences and a strong focus on First-In-Human clinical trials, I help small biotech companies:
- Develop organizational structures that support growth
- Plan and execute clinical trials efficiently
- Build internal expertise through training and SOP frameworks
- Reach recruitment goals on time and within budget
I can help You with
Your Organizational Development In Clinical Research
Set up efficient teams, workflows, and training programs
Your AI Transformation in Clinical Research
Create an AI-First Strategy compliant with regulations
Your Clinical Operations Strategy
Individualize your plans to reach your company goals and clinical trial targets faster
Your Clinical Operations Interim-Management
Supporting and leading your clinical operations team
Your Clinical Project Management
Operational oversight to keep your trials on track
Your Clinical Trials With Cell And Gene Therapies
Specialized knowledge for your clinical trials with advanced therapy
Your SOP Framework
From industry standard to individualized processes
Your Clinical Research Training
From GCP refreshers to tailored internal training
Testimonials
Mrs. Jessica Cordes conducted a 1.5-day in-house training course for T-knife to refresh the regulatory requirements in GCP, GCLP and ATMPs. Mrs. Cordes made this somewhat dry topic interesting with examples and exercises and encouraged the participants to ask questions and engage in discussions. This also demonstrated Mrs. Cordes' in-depth knowledge and extensive experience. The training was therefore very well received by the participants, and we will certainly commission her again for a GCP refresher training course.
Dr. Petra von Stein (Director Quality)
Latest Insights
Clinical Leader
FDA’s Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs
Guest Column | March 4, 2026 FDA's Draft Guidance On Bayesian Methods: [Read article]
Clinical Leader
Why The EU Biotech Act Matters To The U.S.: A Clinical Perspective
Guest Column | January 7, 2025 Why The EU Biotech Act Matters [Read article]
Clinical Leader
Regulatory Pathways – With Real-Life Examples – For Successful CGT Clinical Trials
Guest Column | October 24, 2025 Regulatory Pathways - With Real-Life Examples [Read article]
Explore our Clinical Excellence Community
Clinical Operations Roundtable
a quarterly roundtable with your industry peers
Let's support each other!
- Expand your Clinical Operations Network
- Discuss Clinical Trial Challenges
- Share Experiences between Industry Peers
- Discuss Industry Best Practices
- Align on Optimizations and Innovations
- Get an Overview of updated/new Guidelines
Clinical Operations Spotlight
a bi-weekly newsletter with relevance
Unlock the Power of spotlighted Information.
- Stay ahead with essential Guidelines, expert Tips, and Practical Solutions
- Enable a smoother Clinical Trial Oversight, enhanced Efficiency, and strategic Decision-making
- Get navigated through the evolving landscape of Good Clinical Practice
and benefit from my expertise!
You have generated promising preclinical data.
Now, you want to investigate your Lead Candidate in the First-In-Human Clinical Trial.
Which Goals will you achieve if you recruit your Patients In-Time by using an experienced consultant?
We will review together Your status quo and identify YOUR demands.
We will then prepare an Action Plan to achieve YOUR goals within agreed timelines, budget, and quality.
You are interested in a structured approach with fact-based decision-making?
Do you want to get experienced support to generate your required Clinical Trial Data Package In-Time?
Book an Introductory Meeting now.
© Copyright 2026 - Clinical Excellence GmbH. All rights reserved.