Clin-SKA

Clin-SKA is a freelance clinical operations and quality consultancy founded by Catherine Ska, supporting radiopharma, biotech, pharma, academic and non-profit sponsors across all phases of clinical development.

With more than 25 years of experience in clinical research, Clin-SKA provides hands-on operational, regulatory and quality support for clinical trials, with a strong focus on radiopharmaceuticals, oncology and molecular imaging studies. Services include clinical project management, CRA activities, CTIS and regulatory submissions, site management, TMF and QMS oversight, audit and inspection readiness, CAPA management, vendor coordination, and GDPR/data protection support.

Clin-SKA also has extensive experience supporting radiopharma start-up companies in the set-up, activation and conduct of early-stage and multicentre clinical trials, providing flexible operational support adapted to growing organizations and limited-resource environments. These activities are performed in close collaboration with ClimSquare, combining complementary expertise in clinical operations, quality and study execution.

Clin-SKA is recognized for bringing structure, stability and pragmatic solutions to complex or under-supported clinical trial environments while maintaining a strong focus on patient safety, data quality and inspection readiness.