Be More Diligent. Get More Done.
GOOD CLINICAL PRACTICE
When implementing quality decisions and compliance solutions for your Good Clinical Practice (GCP) investigations, Kymanox draws on its extensive life science and translational medicine experience. We prioritize patient safety and utilize expert project management to ensure scope, schedule, budget, and risk are tracked and communicated throughout your clinical programs.
GCP Compliance Solutions
The Kymanox approach to GCP is synchronized with FDA and EMA statutes and relevant industry guidelines — and also with patient centricity. Kymanox understands your business; we find collaborative, cost-effective solutions focused on the entire lifecycle, from pre-clinical through commercialization and post-marketing activities.
The Kymanox GCP Compliance Team provides services in the following areas:
- Clinical Quality Management System Development and Optimization
- Third Party Audits of Global Clinical Research Organizations (CROs), Investigator Sites, Central Laboratories, and Clinical Trial Supply and Distribution Centers
- Good Documentation Practices and Data Integrity Implementation and Monitoring
- Procedure Development, Training, and Implementation Based on Our www.KymanoxWORKS.com Good Clinical Practice Toolkit
- Clinical Trial Material and Investigational Medicinal Product Support
- Clinical Compliance Gap Assessments
- Vendor Management of Contracted Services and Review of Quality Agreements
- Regulatory Inspection Readiness (e.g., FDA/EMA Mock Audits)
- Seamless Integration with Kymanox Clinical Affairs Support and Clinical Decision Making
Enhanced Regulatory Interactions
With Subject Matter Experts (SMEs) that are Medical Doctors, Public Health Professionals, Biomedical Scientists, Statisticians, Software Validation Engineers, and Global Quality Assurance and Regulatory Compliance Professionals, the Kymanox team eliminates the ambiguity surrounding regulations, published guidance, and study protocol requirements. Kymanox ensures regulatory body expectations, internal processes, and clinical outputs are clear and, most importantly, well-documented. With the support of Kymanox, your interactions with governing regulatory bodies are more predictable, efficient, and productive with fewer nonconformities, questions, and delays. Together with you, we help implement a GCP quality framework that produces documentation to support Right First Time (RFT) regulatory submissions with properly documented and summarized findings from well-controlled clinical studies.