At Pomat Health, quality is not just a checkbox; it is the foundation of everything we do. As a full-service Contract Research Organization (CRO), we collaborate with pharmaceutical, biotech, and medical device companies to deliver clinical trials with the highest levels of safety, ethics, and regulatory compliance.
From protocol design and trial monitoring to data handling and regulatory submissions, our focus remains constant: to uphold the highest standards of integrity and operational excellence.
Our Commitment to Quality
Our approach is built on a comprehensive Quality Management System (QMS) that aligns with international guidelines such as ICH GCP E6 R2, ISO 9001, and regulatory frameworks established by NAFDAC, NHREC, FDA, EMA, and others. These standards guide our commitment to participant safety, data credibility, and full regulatory compliance.
We focus on three essential pillars of quality:
1. Quality Assurance
We emphasise a forward-thinking approach that includes regular audits, Standard Operating Procedure reviews, vendor assessments, and continuous staff development. This allows us to identify and resolve potential issues before they affect trial integrity.
2. Quality Control
Our rigorous quality checks cover all stages of clinical trial execution. These include data verification, source document review, and continuous tracking of protocol adherence. This ensures that all outcomes are accurate, consistent, and dependable.
3. Continuous Improvement
We believe that quality is a journey, not a destination. Using methodologies such as Plan Do Check Act, Lean, and Six Sigma, we routinely evaluate and enhance our processes. Corrective and Preventive Actions, audit insights, and stakeholder feedback help us drive meaningful improvements across all operations.
Navigating Operational Challenges
We understand the demands of managing evolving regulations, complex data collection environments, and multiple trial sites. To meet these challenges, we utilize electronic QMS platforms, apply risk-based monitoring strategies, and invest in continuous training to strengthen our team’s capabilities.
Integrity and accountability are central to our system. Our operations are designed to maintain inspection readiness at all times, ensure accurate and complete documentation, and foster consistent quality growth across every function.
At Pomat Health, quality is more than a standard. It is our identity. We are dedicated to advancing research that leads to better health outcomes around the world.
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