Quality Assurance Department

At Ethicare Clinical Trial Services, our Quality Assurance (QA) Department is dedicated to maintain the highest standards by operating independently to ensure strict compliance with projects, protocols, SOPs, and regulatory requirements, while prioritizing subject safety and the integrity of data. Backed by an experienced team, we provide end-to-end support for regulatory inspections—including TGA, FDA, WHO, MHRA, EMA, Kazakhstan and other authorities—covering preparation, hosting, management, and closeout. Each year, we successfully facilitate numerous client audits with minimal to no findings, reinforcing inspection readiness and building confidence at every step. Our QA function also carries out detailed assessments of vendors and Contract Research Organizations (CROs) to confirm adherence to rigorous quality standards. By remaining independent from project operations, the QA department ensures objective evaluations that strengthen transparency and integrity. This comprehensive QA framework ensures that every study conducted at Ethicare embodies excellence in quality, regulatory compliance, and an unwavering commitment to patient safety.

  • System and Vendor Audits involve comprehensive evaluations across all key functions—including Pharmacovigilance, Clinical Trials, Pharmacy, Data Management, etc. Along with thorough assessments of vendors’ processes, systems, and compliance with both contractual obligations and regulatory requirements.
  • Good Clinical Practices: We are committed to upholding the highest standards of Good Clinical Practice (GCP), a cornerstone in protecting the integrity, safety, and reliability of clinical trials. GCP provides a robust framework that guides the design, conduct, monitoring, and reporting of clinical research, ensuring every study is carried out with the utmost ethical and scientific excellence. At the core of our approach lies an unwavering dedication to quality in every aspect of our work.
  • At ECTS, we provide Quality Audit Services andGood Clinical Practice (GCP) Consulting and Documentation Review to help ensure compliance and integrity in clinical research. Our audits cover investigator sites to check compliance with GCP guidelines and trial protocols, and detailed checks of Trial Master Files (TMFs) for accuracy, completeness, and regulatory compliance. Alongside audits, we also review protocols, SOPs, and essential documents to make sure they meet GCP requirements and offer consulting support to ensure full compliance with international regulations. This combined approach helps our clients improve quality, maintain transparency, and stay compliant throughout their clinical operations.
  • Good Pharmacovigilance Practices: At ECTS, we demonstrate our commitment to patient safety through robust Good Pharmacovigilance Practice (GVP) solutions, carefully monitoring, analysing, and reporting safety data to ensure strict compliance with regulatory requirements while safeguarding public health. In line with this commitment, we take pride in delivering Pharmacovigilance (PV) system and process audits that empower our clients to consistently achieve successful outcomes, combining proactive strategies, advanced technology, and a culture of continuous improvement to provide strong support in navigating the complexities of PV compliance.
  • Mastering Pharmacovigilance Audits with a Risk-Based Approach involves using a structured methodology to identify and prioritize high-risk areas within the Pharmacovigilance system, where risk is defined by the likelihood of an event occurring that could affect key objectives, considering both its severity and the chance of it going undetected. This approach ensures focus on critical areas such

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