QUALITY ASSURANCE

Ensuring quality is paramount in drug development, and at LBR, it's ingrained within every facet of our clinical studies, spanning from inception to completion. We conduct internal audits throughout the study lifecycle, ensuring consistent and high-quality performance across all operations.

Our staff is experienced in conducting various types of audits, including routine QA site audits, for-cause site audits, and site inspection readiness audits for FDA/EMA inspections. We also conduct vendor qualification audits across a global footprint, encompassing regions such as the Americas, Europe, Eastern Europe, Asia, India, Australia, and Africa.

Our quality assurance audits are planned in collaboration with our clients, ensuring alignment with their specific areas of concern or interest. Throughout the audit process, our auditors collaborate closely with sponsors, reporting findings and compiling comprehensive audit reports for review and action.

Upon agreement on findings, they are subjected to thorough review and closure processes, ensuring that any identified issues are effectively addressed and resolved to uphold the highest standards of quality and compliance.