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Maintaining regulatory compliance and data accuracy in clinical trials is vital for any clinical research organization (CRO) striving for integrity and efficiency. This clinical trial QA and QC case study highlights how one CRO overcame growing challenges in ensuring consistent documentation, meeting strict international standards, and reducing the workload on its internal teams. By partnering with CORE® to build an offshore QA and QC team in the Philippines, the company improved compliance, accelerated submissions, and achieved measurable cost and performance gains.
The Importance of QA and QC in Clinical Trials
Quality assurance (QA) and quality control (QC) are the backbone of reliable and credible clinical trials, where even minor data discrepancies can cause delayed submissions, heightened audit risks, and compromised outcomes. A strong QA/QC function ensures full regulatory compliance with FDA, HIPAA, and ICH-GCP standards, delivers accurate and verified trial data that meet global expectations, and boosts operational efficiency by allowing internal teams to focus on high-value trial activities.
For this company, strengthening QA and QC was more than a compliance requirement; it was a strategic investment in long-term trial success. By leveraging managed QA and QC clinical research services, they were able to safeguard data integrity while keeping operational timelines on track.
The Challenge
The company encountered several operational and compliance obstacles, including:
- Data Inconsistencies: Repeated documentation errors delayed approvals and reduced data reliability.
- Compliance Risks: Heightened scrutiny from regulators increased the pressure for error-free submissions.
- High Internal Burden: Internal teams struggled to manage both operations and compliance responsibilities.
These challenges made it clear that a more scalable and specialized approach was needed to ensure consistent oversight and maintain audit readiness. The company sought a partner that could deliver compliance outsourcing for clinical trials while maintaining complete alignment with regulatory standards.
The Solution: Partnering with CORE®
To address these challenges, the CRO partnered with CORE for a fully managed QA and QC clinical research solution. Our offshore service provided a comprehensive setup covering recruitment, onboarding, HR, compliance management, and performance tracking, allowing the company to focus on achieving successful trial outcomes.
Our team structure and operational framework offered end-to-end coverage through our offshore QA and QC services in the Philippines, including:
- Quality Assurance: Overseeing systems, workflows, and documentation to ensure compliance with company and regulatory requirements.
- Quality Control: Reviewing data entries and reports to ensure precision and consistency.
- Audit Preparation: Maintaining audit-ready documentation aligned with FDA and ICH-GCP guidelines.
- Continuous Improvement: Identifying recurring process gaps and implementing long-term corrective measures.
The CORE® QA and QC specialists played a pivotal role in driving data accuracy in clinical trials and regulatory compliance within BPO industry standards. Their daily functions included reviewing and validating trial data, coordinating with sponsors and CRO teams, implementing automated monitoring tools, and preparing compliance reports for ongoing audits. Overall, this integrated approach demonstrated how partnering with a managed expert can streamline complex compliance needs into scalable, efficient operations that strengthen data reliability across clinical trials
Why the Philippines for Compliance Outsourcing?
Choosing the Philippines as the hub for compliance in outsourcing clinical trials offers several strategic advantages:
- Skilled Talent Pool: A workforce with strong backgrounds in life sciences, nursing, and pharmaceuticals.
- Regulatory Familiarity: Professionals experienced in international standards and compliance protocols.
- Cost savings offshore QA and QC: Up to 60% savings compared to onshore quality teams.
- Scalable and Flexible: Teams can be rapidly expanded based on study volume and audit timelines.
The combination of technical expertise and cost efficiency made the Philippines a leading destination for offshore QA and QC operations, ensuring both performance and profitability.
The CORE® Advantage
Our managed QA and QC clinical research solution delivered unmatched reliability and transparency. Key differentiators included:
- Proven Expertise: QA/QC specialists meeting compliance KPIs across diverse trial types.
- Managed Services: CORE oversees HR, payroll, operations, and compliance, minimizing administrative overhead.
- Performance monitoring in clinical research: Dedicated operations managers track accuracy, productivity, and adherence to global standards.
- Data Security: Teams operate from secure, CORE-managed office with reliable systems and data security.
These strengths positioned CORE as a long-term partner capable of scaling and optimizing QA and QC operations for global companies.
The Results
The partnership yielded significant improvements across key performance metrics:
- Improved Data Accuracy: Trial documentation error rates dropped by 45%.
- Accelerated Submissions: Streamlined QC workflows reduced regulatory approval timelines.
- Enhanced Compliance: Zero major audit findings across all supported trials.
- Cost Efficiency: Over 50% savings compared to in-house staffing.
- Reduced Internal Burden: Company teams reallocated efforts to strategic research and development.
These outcomes highlight how implementing offshore QA and QC services in the Philippines can significantly enhance operational results and compliance reliability in clinical trials.
Strengthening Clinical Research Operations
By leveraging our managed QA and QC clinical research solution, the company achieved measurable success in efficiency, compliance, and data integrity. The collaboration not only reduced internal strain but also improved oversight and accountability throughout each trial phase. Ultimately, this clinical trial QA and QC case study illustrates how offshoring compliance functions can support scalability, cost efficiency, and consistent quality for CROs operating globally.
Delivering Compliance, Accuracy, and Efficiency
Partnering with us enabled the company to transform its QA and QC operations into a sustainable, high-performance approach. Through specialized offshore teams and proactive performance monitoring, we ensured every trial phase adhered to the highest regulatory compliance standards.
Discover how our offshore QA and QC solutions in the Philippines can enhance your clinical trial operations and improve accuracy. Connect with us today to learn more about our expertise in managed QA and QC clinical research.
