QA for Clinical Trial Data
Proactive QA produces clinical trial data that facilitates product approval
Ensuring high-quality data is derived from clinical trials requires a multi-faceted approach. The UBC Quality Assurance team:
- Advises clients on data verification best practices
- Partners with other UBC teams to develop clinical trial protocols that adhere to international regulatory guidelines
- Develops informed consent forms (ICFs) appropriate to the therapeutic area, drug class, product label, subject/patient and conform to national and international regulatory guidelines
- Proactively monitors updates to location, national and international regulatory requirements and updates UBC standard operating procedures to be compliant
- Ensures trial sponsors have access to technology that facilitates data collection while protecting patient privacy
- Educates UBC staff and provides tools to ensure clients are provided the best quality oversight
Monitoring changes in global and country regulatory requirements can be a full-time job. UBC employs quality assurance and regulatory experts who monitor changes to regulatory requirements and ensure our processes are updated accordingly. This alleviates the burden on our clients and ensures clinical programs are designed following the most current regulations.
Commitment to Success
UBC is audited approximately 70 times each year and consistently clients find no critical issues. In addition, UBC has passed numerous FDA audits on behalf of our clients and the Agency to ensure programs are conducted in compliance with regulatory requirements.
Put our quality assurance experts to work for your trial. Contact us to learn more.