GCP and GVP auditing

The audits will allow the identification and the evaluation of risks and areas for improvement, which will maximize inspection readiness and process improvement. 

ObelysQ can help you having meaningful and impactful audits. At an early stage, we can help you establish an audit strategy which will ensure an efficient use of your resources. You can also ask ObelysQ to conduct the audits on your behalf, our team has experience with various types of indications, dosage forms, vendors, and systems, and this on all continents!

Investigator site audits

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

GVP audits

ObelysQ can conduct pharmacovigilance audits.

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

  • PV processes
  • Affiliates
  • Vendors

Vendor audits

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

Systems audits

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