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CTS Operations

Extensive experience in end-to-end management of clinical trial supply. Coordination with CMC, Clinical, DM, QA/QP, and CMO/third-party depots.


GxP System Validation

Computer system and equipment validation framework to ensure compliance with current EMA and ISPE guidelines, and in line with your QMS system.   

Experts in IRT/RTSM system requirements, operations, and UATs to ensure suitability against study design. Development and execution of system test scripts.

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System Vendor Selection

Requirement specification and vendor selection projects of GxP systems and outsourcing of GMP/GDP activities.

Drug Supply Forecasting

SaaS solution provider of a clinical trial supply forecasting tool. An intuitive platform that integrates with all IRT systems.


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Process Optimisation

Executes your QMS and SOP writing projects with broad experience in best practices from leading pharmaceutical and biotech companies. 

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