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Quality Assurance & Compliance
Systems That Keep Every Study Accountable.
Our Quality Assurance (QA) Department is responsible for establishing and maintaining systems that ensure clinical research activities are conducted consistently, ethically, accurately, and in compliance with applicable regulations, guidelines, protocols, and standard operating procedures (SOPs).
A typical QA audit at Clinwave follows a structured path: audit planning, preparation, audit execution, findings, audit report, CAPA (Corrective and Preventive Action), CAPA follow-up, and closure — so that any gaps are identified and resolved systematically.
All our QA systems are compliant with applicable local and international regulations, giving sponsors confidence in the integrity of every study we support.
Our Quality Assurance Services
In-House Auditing Capability, Full Compliance Coverage.
Clinwave has in-house capabilities to perform a wide range of audits and compliance reviews, covering sites, vendors, documents, and internal SOP adherence.
Site & Vendor Audits
On-site investigator audits and vendor audits to verify consistent, compliant study conduct.
Document & GCP Compliance Review
Document audits of protocols, clinical study reports and essential trial documents, plus GCP compliance review.
IRB / EC Audits
Reviewing adherence to Institutional Review Board and Ethics Committee requirements throughout the study.
Drug Accountability & Internal Audits
Drug accountability reviews, study document reviews, and internal audits for area-specific SOP compliance.
Every audit follows the same disciplined path — planning, preparation, execution, findings, and a formal audit report.
Findings are addressed through CAPA and CAPA follow-up, with closure confirmed once corrective actions are verified.
Frequently Asked Questions
Establishing and maintaining systems that ensure clinical research activities are conducted consistently, ethically, accurately, and in compliance with regulations, guidelines, protocols, and SOPs.
Audit planning, preparation, audit execution, findings, audit report, CAPA, CAPA follow-up, and closure.
Site audits, vendor audits, document audits, GCP compliance reviews, IRB/EC audits, on-site investigator audits, drug accountability reviews, and study document reviews.
Findings move into CAPA (Corrective and Preventive Action) and CAPA follow-up until the issue is resolved and the audit can be closed.
Yes, all our QA systems are compliant with applicable local and international regulations.