QA Activities & Audit Services

CROss Alliance Quality Assurance Unit, enforces the highest quality standards to ensure that all the CRO activities are performed and the data are generated, recorded, and reported in compliance with ICH-GCP and the applicable regulatory requirement(s).

Quality is ensured through:


Documented, SOP based, work-flow;

Systematic, documented and effective controls of all study steps (from protocol to final report and archiving);

Systematic, documented subcontractors audits (e.g. analytical and clinical labs) to ensure reliability and compliance to the highest quality standards;

Continuous and documented training to ensure that the staff is always qualified and updated with the latest regulatory requirements;

Tight connection with Quality Associations (e.g. RQA formerly Barqa & Giqar);

As additional service, we provide audits to facilities, trials and registration dossiers to assess compliance with Clients requirements and/or national or international quality standards.

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