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
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.
what our clients say
Ulf Grawunder
(PhD) CEO from T-CURX
"Working with Cornelia on setting up Phase 1 clinical trials across two companies and two different drug modalities (at NBE Therapeutics for ADCs, at T-CURX for CAR-T therapies) has been and still is a very rewarding experience. Her depth of knowledge, strategic thinking, and hands-on attitude have made her an invaluable partner and paved the way to a smooth initiation of our clinical trials. She ensures operational excellence, knows how to manage the various stakeholders, incl. CROs, investigators, regulators, etc. and keeps all required documentation and processes under control. Simply put, she gets things done — and she does it very well"
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!