Quality at CRONCOX isn't a department — it's the operating model. Our entire delivery is engineered to pass regulatory inspection without a moment's preparation.
The foundation of all clinical operations at CRONCOX. Every team member is GCP-trained, certified, and re-trained annually. SOPs map directly to ICH-GCP principles.
Electronic records and signatures fully compliant. Audit trails are continuous and tamper-evident. System validation lifecycle documented (IQ/OQ/PQ).
Computerized systems aligned to EMA's Annex 11. Risk-based validation, supplier qualification, and change control built into every system.
Patient data protection by design. Pseudonymization, lawful basis documentation, data minimization, and subject rights workflows in place.
Full alignment with India's CDSCO requirements under Schedule Y and the New Drugs Rules. SUGAM portal experience.
CDASH for collection, SDTM for tabulation, ADaM for analysis. Define-XML and Reviewer's Guide built into every submission package.
CRONCOX's quality management system is built around continuous compliance — not annual scrambling. Internal audits, CAPA management, deviation tracking, and document control operate on rolling cycles.
Role-based access. Multi-factor authentication. Quarterly access review. Audit trails on all GxP system access.
AES-256 at rest. TLS 1.3 in transit. End-to-end encryption for all PHI transfers. Encrypted backups stored offsite.
Continuous incremental backups. RPO < 1 hour. RTO < 4 hours. Disaster recovery rehearsed quarterly.
GAMP 5 framework. URS, FS, DS, IQ, OQ, PQ, and PVR for every GxP system. Continuous validation maintenance.
Complete, tamper-evident, secure timestamped audit trails on all data changes. Per 21 CFR Part 11 §11.10(e).
Documented BCP, regular tabletop exercises, geographically separated data centers, and 24/7 incident response.