Project study monitoring of Developmental and Reproductive Toxicology (DART) (eg, Embryo-Fetal Development [EFD], Fertility and Early Embryonic Development [FEED], Pre- and Postnatal Development [PPND]) and General Toxicology studies conducted at CROs:

• Input on study design and protocol

• Overseeing in-life and post-life phases of the study.

• Data review, report review from draft to finalization and Common Technical Document (CTDs).

• Site visits (as needed) for inspection of in-life processes ensuring compliance with Good Laboratory Practice (GLP) regulations (as appropriate), animal welfare standards, and Standard Operating Procedures (SOPs).

• Collaboration with CRO Study Directors to evaluate and interpret study results and maintain established timelines.

• Assist with evaluating DART technical capabilities for onboarding of new CROs.

Training services in all aspects of fetal morphology evaluations (multiple species).

Fetal morphology evaluations (eg, fresh viscerals, Bouin’s fixed heads, and skeletons).

  Peer review of fetal morphology findings.