- Conduct an expedited micronucleus (MN) assay in mice and comet assay in rats.
- Accelerate timeline to accommodate a meeting between the client and the FDA, leading up to NDA filing, leaving little room to deal with any unanticipated events.
- Work around effects induced by the test chemical that were observed in rangefinder studies, which hampered determination of maximum tolerated dose for use in the definitive studies.
- Coordinate QA facility inspection prior to start of study.
- Synchronize expedient analytical chemistry tasks with third-party lab.
- Successfully completed high-quality GLP- and OECD-compliant MN and comet studies within required timeframe, and provided an eCTD-formatted (Electronic Common Technical Document) final report.
- Reduced study costs and minimized timeline by creating a customized protocol that merged concurrent conduct of mouse MN and rat comet assays into a single study with a single protocol and report.
- Worked beyond normal hours to tackle issues promptly as they arose, keeping the project moving as quickly as possible (for example, rescheduling necropsy on a weekend to avoid delays).
- Coordinated extensive team (client, consultant, study director, technical staff, analytical lab), while maintaining close contact with client to provide status updates and results of each phase of the study, and quickly make requested revisions to study documents.
- Client and consultant were very pleased with both the scientific quality and turnaround time, and appreciative of ILS’ ability to overcome challenges and keep the submission on track.