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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 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. CRO audits also ensure that the rights and well-being of study participators have been protected.

 

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 needs (e.g. SOPs) as the assigning sponsor. Each audit includes the creation of detailed audit reports.

 

 

Routine Audit

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

 

Audit Report

The Audit report is a written report from the monitor to the sponsor after site visit. It contains the written evaluation of the results of the systematically carried out audit 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.