Integrated Quality Assurance Process
YOLARX strives to ensure that high quality standards will be applied to all the work undertaken throughout the study and to delivery of the final report or even manuscript. Our quality assurance process includes enforcing the use of formal procedures for testing and validating all software developed in the project, document control, and by developing early in the project quality guidelines that affect all work and procedures that need to be implemented.
Through training, expert advice, or research, we demonstrate our understanding of the process by which evidence is reviewed by regulators and payers.
Our work will meet the challenges of the most critical and demanding peer review process. We follow the most up-to-date guidance documents and regulatory requirements:
- EU template for RMP
- ENCePP Guide of Methodological Standards
- Good Pharmacoepidemiology Practice guidance
- Good Pharmacovigilance Practice
- Good clinical practice (21 CFR part 11)
- ICH E2E
- New EU Pharmacovigilance legislation etc.