SQA 2025 -- Vulnerable populations are groups of people that are at an increased risk and require additional protections when conducting clinical trials. There are many vulnerable groups in the population, but this poster will focus on children, older adults, pregnant women and people with rare diseases.

SQA 2025 -- It is an industry expectation that sponsors will conduct a quality audit for contract research organizations (CROs) performing preclinical studies. As a client audit host, there are things you can do to support a successful audit. Preparation for the audit ahead of time is key. What can be done to prepare for a sponsor audit?

SQA 2025 -- The purpose of the phase audit is to monitor each study to provide assurance to test facility management. The phase audit report is sent to both the study director and to test facility management.

SQA 2025 -- A nonclinical laboratory study was conducted following the Sponsor-approved protocol and the data has been collected. As the Study Director tabulates the data and draws their conclusions, the Sponsor asked to review drafts of the main study report and all principal investigators/contributing scientist reports.

SQA 2025 -- ISO/IEC 17025:2017 is a quality management system (QMS) that describes the general requirements for the competence of testing and calibration laboratories. Who does this apply to? Why is it important? What are the requirements? What are the benefits of a quality system based on ISO 17025?

SQA 2025 -- The goal of assuring the integrity of data never changes, when conducting audits. Multiple approaches may be utilized based on the type of study conducted. Compendial methods that a lab conducts routinely have different risks than a complex, one-time study.