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Contract Research Organisation Audit

 

Reasons to Assign a CRO Audit

CRO audits are a vital part of your quality management, ensuring that your chosen strategic partner performing nonclinical and clinical studies and other critical drug, biotechnology, or medical device development services on your behalf are accordingly carried out within the life-sensitive business of health science, where a small error can yield harmful repercussions.

 

 

Ensuring

CRO audits ensure that the study data and results are credible and accurate and that the rights and well-being of study participants have been protected. CRO audits also ensure that your operational units including your external service providers, systems, processes, documents, and records comply with relevant requirements.

 

Anticipatory

CRO audits carried out by IASON consulting can help your organisation in identifying and solving research, study, and manufacturing deficiencies of your medical device, drug, or biotechnological product before they become unmanageable, time-consuming, or too expensive to be fixed.

 

IASON CRO Service in Detail

As experienced, reliable, and trusted advisor, IASON consulting conducts routine CRO audits, specifically and individually prepared according to general standards and guidelines of regulatory agencies (e.g. FDA, EMA) and your particular requirements as the sponsor (e.g. SOPs). Each audit includes the creation of a detailed audit report.

 

 

Routine Audit

The study-orientated audit focuses on ensuring that a site is complying with the respective protocol, SOP, GLP, GCP, and applicable regulatory requirements.

 

Audit Report

The Audit report is prepared by the auditor and handed over to the sponsor for further consideration. The report summarises all audit activities and audit observations, and it provides an independent and impartial evaluation of the audit results revealed by IASON consulting as an independent and impartial provider of consulting services.

Contact

Please do not hesitate to contact us to find out more about systematic and independent CRO audits carried out by IASON consulting.