Radiopharma Clinical Operations & Quality Expertise

Providing hands-on operational and quality support for radiopharmaceutical and oncology clinical trials, from early study set-up to daily study conduct and inspection readiness. Expertise includes CTIS and regulatory submissions, site activation, monitoring activities, TMF/QMS oversight, vendor coordination, protocol deviation and CAPA management, as well as support for decentralized radiopharmacy and imaging studies.

Particular experience in supporting biotech and radiopharma start-up companies requiring flexible, pragmatic and high-level operational expertise to build and maintain compliant clinical trial processes in fast-moving environments.

Working in close collaboration with ClimSquare as needed, we offer a complementary “binome” approach providing a broad and flexible package of expertise in clinical operations, quality and study execution — serving as an agile and cost-efficient alternative to large CRO structures while maintaining high quality standards and close sponsor interaction.