At ObelysQ, audits are planned and conducted using a risk-based, regulator-focused approach tailored to the specific context of each program, organization, and development stage. We begin by understanding your regulatory exposure, trial design, vendor landscape, and inspection history to define clear audit objectives and scope. Our audits are performed by senior quality professionals with hands-on operational and inspection experience. During the audit, we focus on what truly matters: patient safety and data integrity and we ensure that all gaps and risks are identified.
We were unhappy with the outcome of investigator site audits conducted by our CRO and reached out to ObelysQ to support our urgent auditing needs in Europe. We appreciated having direct access to quality professionals—not just project managers. The outcomes of their audits were very impactful.
Clinical Quality Lead, Mid-size Biotech, Boston Area
ObelysQ audit reports are complete and clear, with findings prioritized based on regulatory risk and inspection impact. Beyond reporting, we actively support clients in defining robust, pragmatic CAPAs, ensuring findings are not only addressed but sustainably resolved. Our clients value that our audits drive real improvement, strengthen inspection readiness, and provide management with the clarity needed to take informed decisions.
Case Study
Overview: A French pharmaceutical company preparing for a marketing authorization application needed to ensure its pharmacovigilance system was fully compliant with Good Pharmacovigilance Practices (GVP). To assess readiness and identify potential gaps, the company engaged ObelysQ to conduct independent GVP audits.
Challenge: The pharmacovigilance system had expanded rapidly, involving multiple vendors and affiliates. Concerns included:
- Consistency of safety data management
- Robustness of signal detection and risk management processes
- Completeness and traceability of PSMF documentation
With limited internal audit capacity and an upcoming regulatory submission, the company required an expert external review under tight timelines.
Results: ObelysQ deployed senior GVP auditors who conducted a series of targeted audits covering core and support PV processes. We delivered prioritized findings and pragmatic, regulator-focused recommendations. The client closed critical gaps ahead of submission and subsequently passed a regulatory inspection with no major findings.
Overview: A US-based biotech needed assurance that its key vendors—including CROs, laboratories, and eCOA providers—were compliant with GCP and GcLP requirements. ObelysQ was engaged to perform a series of vendor audits.
Challenge: The company relied on a complex ecosystem of vendors delivering critical services across regions and technologies. Internal teams lacked the bandwidth and specialized expertise to audit this diverse vendor landscape comprehensively and consistently.
Results: ObelysQ auditors with deep expertise in vendor auditing developed risk-based audit plans tailored to each vendor’s role. The audits identified major compliance gaps and operational risks. ObelysQ supported the biotech to ensure that robust CAPAs were identified and implemented.
Overview: A European biotech running a multi-country Phase II clinical trial required investigator site audits following concerns raised during routine monitoring.
Challenge: The sponsor suspected variability in protocol adherence, source data documentation, and informed consent practices across sites.
Results: ObelysQ conducted focused, on-site GCP audits using a risk-based approach aligned with inspection expectations. Our auditors identified systemic issues and site-specific risks. The sponsor implemented corrective and preventive actions with support from ObelysQ. One of the audited sites was inspected by Health Authorities with no major finding.
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