top of page
Titelbild 1.2

Clinical Trials. Empowered.

Build Smart. Run Fast. Stay Compliant.

Empowering biotech startups with expert Clinical Operations support and a ready-to-use QMS — from study startup to trial rescue.

ARE YOUR CLINICAL TRIALS

FACING THESE ISSUES?

Regulatory Complexity slowing you down? We help you stay ahead.

 

CRO Performance Issues: Missed timelines, budget overruns, or limited transparency undermining your trial delivery?

 

Facing recruitment challenges: Are your sites losing momentum or interest?

 

Data Integrity Concerns: Inadequate oversight exposing you to compliance risks and regulatory findings?

 

Operational Gaps: Lacking in-house expertise to effectively manage vendors, systems, or complex trial operations?

 

Trial Rescue Services: Is your trial off track, underperforming, or at risk of failing key milestones?

Operational Gaps Holding You Back?

Cetacea delivers end-to-end Clinical Operations support tailored to your trial.

Quality Gaps

Slowing You Down?

Cetacea brings the processes, structure, and documentation your trial needs to move forward.

Cetacea steps in as your full-function

Clinical Operations department

whether you're starting fresh or need to get a trial back on track. From startup to rescue, we bring structure, strategy, and execution expertise. We manage timelines, vendors, quality, and compliance so you can focus on the science and your next milestone

Titelbild 2.png

WHAT WE DO AT CETACEA CLINICAL?

End-to-End Clinical Operations: From trial design to trial close-out.

Strategic Consulting: Ensuring efficient trial planning, budgets, and vendor selection.

CRO & Vendor Oversight: Managing external providers for maximum efficiency.

Trial Rescue: Fixing stalled or troubled trials to ensure regulatory compliance.

Quality Management System (QMS): A fully developed, ready-to-implement solution for Biotech startups.

THE IMPACT OF OUR WORK

Trials start faster & run smoothly.

Identifying and resolving potential pitfalls early.

Meeting regulatory expectations for reliable results.

Engaged investigators & optimized site performance.

Smart vendor selection & budget-friendly strategies.

IMPACT 2_edited.png

what our clients say

"Thanks to Cornelia’s structured approach, we were able to launch our first clinical trial faster and with a clear budget strategy. Her expertise was a game-changer for our startup."

- CEO, Biotech Startup

Titelbild 3_edited.jpg

our services

TAILORED SOLUTIONS FOR EVERY STAGE OF YOUR TRIAL

Startup Package

Strategic trial setup & vendor selection

Oversight Package

Hands-on CRO & site management

Rescue Package

Fast intervention to fix struggling trials

QMS Implementation

Ready-to-use Quality Management System

Custom solutions available

Contact us for a tailored approach

TITELBILD 5_edited.jpg

MEET CORNELIA BAUMGARTNER

With over 25 years in clinical research,

I specialize in helping biotech startups navigate their first trials and rescue struggling trials. My expertise spans strategic operations, CRO oversight, and regulatory compliance. I bring a hands-on, results-driven approach to every project—ensuring studies meet their milestones efficiently and successfully.

Founder | Clinical Operations Expert | Turning Complexity Into Clarity

CONTACT

​Ready to ensure your trial’s success? Get in touch today!

bottom of page