GCP and GVP auditing

ObelysQ can help you identify which sites should be audited in order to maximize your efforts.

Do not hesitate to leave your audit program in our hands. We will bring to the table our expertise, flexibility, and pragmatism.

ObelysQ will deliver your audit report in a timely fashion and will provide guidance to help resolve the issues identified. We can also ensure the follow-up of the corrective and preventive actions on your behalf.

• Routine audits
• For-cause audits
• Targeted audits

ObelysQ can conduct pharmacovigilance audits.

Whether in house or outsourced, we can help identify GVP compliance gaps.

• PV processes
• Affiliates
• Vendors

ObelysQ can perform qualification/routine/for-cause audits of your vendors to ensure that your company’s interests are best served.

Let us help you identify the best fit for your project according to your needs and means.

Vendor oversight will be evaluated during health authority inspection, so it is important that you have proper control over all delegated tasks.

• Central Laboratories
• Central Assessment/Review Facilities (ECG, Imaging)
• Homecare Providers
• Site Management Organizations
• Clinical Research Organizations
• Interactive Response Technology
• Patient Reported Outcomes Service Providers

ObelysQ will help you evaluate your Quality Management System and processes, and assess whether they comply with regulations, are in line with best business practices and whether they are adhered to.

Tip: One of our clients's preferred choice is the full clinical trial audit, reviewing all processes for you key trials!

• Process audit
• Quality Management System audit
• TMF audit
• Document audit
• Database audit
• Affiliate audit