CRO Selection & Qualification Auditing
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CRO Selection & Qualification Auditing

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Clinical & Bioanalytical Phase

CRO Selection & Qualification Auditing

Appropriate CRO selection is the first step towards increasing chances of a successful outcome. There is a need of mapping your requirements and CRO capabilities to check the perfect fit. Probably you need to check on this on a case-by-case basis.

 

1. We provide this service to our clients to help them in selecting the best CRO for each product; based on our experience with the CROs working in MENA region, taking into consideration the type of product, type and design of the study, the API, and the previous history of the CRO with similar products/studies.

 

2. We also provide quality audit to assess the CRO qualification regarding, facilities, quality system, data integrity, IT, organization, and personnel. This is to ensure that BE studies will be conducted, and the data will be recorded, analyzed, and accurately reported

 

According to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP) and the applicable guidelines and regulatory requirements.

 

According to our SOPs, our experienced auditors, using carefully designed checklists to perform the auditing activities that include but not limited to:

 

• Review SOPs to ensure that procedures and systems used in the conduct of the study are in compliance with applicable guidelines and regulations.
• Assess compliance with the GCP and GLP guidelines.
• Review the Site Master File and organization chart, qualifications, and training of the CRO project team members, workload and turnover rate.
• Assess the Quality Management System, including Quality Manual and Policy
• Review QA unit reporting structure and auditing practices.
• Review calibration and maintenance plans and procedures.
• Assess vendor qualification and managements.
• Assess computer system procedures and documentation including those for security, backup and recovery.
• Assess prior regulatory inspection history and interpretation