Phase 1 trials, be they conducted on healthy volunteers or patients, focus on generation of initial knowledge on tolerability, safety and PK/PD.. These trials determine the maximum tolerated dose without unacceptable side effects and may involve some risks, even after passing preclinical testing. While typically conducted with healthy subjects, Phase 1 trials may include severely or terminally ill patients. The process takes several months, and around 70% of experimental drugs successfully advance beyond this initial phase.
CVBF offers training modules tailored to Phase I Unit staff, focusing on the Italian Medicines Agency (AIFA) requirements.
This module covers AIFA’s determinations and insights from past inspections.
Our activities include thorough reviews of existing documentation, personnel, facilities, and equipment, along with assistance in preparing essential documentation and standard operating procedures (SOPs).
Elevating Clinical Trials through Auditing
CVBF’s dedication to excellence extends to auditing, ensuring that every aspect of clinical trials complies with protocol, good clinical practices and applicable regulations. Our experienced auditors provide comprehensive system and study auditing services, strengthening the quality and reliability of your trials.
At CVBF, we are not only dedicated to advancing medical research but also to ensuring that every phase of clinical trials is conducted with the highest standards of quality guaranteeing that data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Partner with us, and together, we will contribute to the advancement of healthcare for all.
If you have a specific question or request, contact us at [email protected]