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Ensuring high standards in clinical trial audits through expert assessment, regulatory compliance, and alignment with global best practices to maintain quality at every step.
The reliability of electronic data is utmost important in the digital age. CurexBio leverages cutting-edge EDC systems for clinical trials as a cornerstone of our quality and compliance strategy. These systems are not just for data capture; they are integral tools for ensuring high-quality, auditable, and secure clinical data.
Our chosen EDC systems for clinical trials are fully compliant with 21 CFR Part 11, the FDA regulation governing electronic records and electronic signatures. This ensures that all electronic data collected is trustworthy, reliable, and equivalent to paper records, providing an undeniable audit trail and enhancing the acceptability of your data by regulatory agencies.
CurexBio EDC system undergoes diligent data validation checks, ensuring real-time uniformity and range checks at data entry. This proactive validation minimizes errors and inconsistencies. Every action within the EDC system is documented in a comprehensive audit trail, ensuring regulatory scrutiny and transparency of clinical trial data, thereby ensuring accountability.
Our EDC systems prioritize the security of clinical trial data by implementing robust measures like user access controls, data encryption, and secure backups. Integral query management system accelerates organized communication between sites and data managers, allowing instant resolution of errors and quality compliance.
We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Streamline Your Drug Development with Curexbio CRO Expertise
1113, Silver Radiance 4 Sarkhej – Gandhinagar Hwy, Chanakyapuri, Ahmedabad, Gujarat 382481
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