How CORE® Improved Trials: A Clinical Trial QA and QC Case Study

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.

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.

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.