Cetacea Clinical GmbH

Startup

Cetacea Clinical GmbH is your dedicated Clinical Operations Department — ready when you are. With more than 25 years of experience in clinical operations and regulatory compliance, Cetacea Clinical supports biotech sponsors and small pharma as a trusted, flexible partner.

At the heart of our services is a fully developed, inspection-ready Quality Management System (QMS) that can be deployed immediately. This proven framework helps sponsors meet ICH-GCP E6(R3) and global regulatory expectations from day one, giving you a head start on quality, compliance, and operational excellence — without building from scratch.

Cetacea Clinical can operate as your complete Clinical Operations Department, seamlessly managing trial planning, execution, vendor oversight, eTMF setup, archiving, and team training. Or, if you prefer a more boutique approach, you can pick and choose the exact services you need — from study rescue to targeted sponsor oversight — tailored flexibly to your requirements.

We believe your trial is too important to leave to chance, and your data is too valuable to risk. Let’s work together to ensure your study is documented, managed, and delivered with the highest standards of quality, compliance, and confidence.