Expanded Commitment to a Sustainable Future
U.S. Testing and Regulatory Solutions Now in Greenfield, IN
Expanded U.S. capacity and high-quality study execution conducted by expert study directors at our expanded Greenfield, Indiana site.
Bringing clarity and logistical excellence to DART
Over 40 years’ experience in developmental and reproductive toxicology, building vital scientific insights, validated technologies and comprehensive historic datasets
Leverage the expertise of a large and experienced team of study directors, senior scientists, behavioral specialists, specialized reprotoxicology animal technicians, repro necropsy specialists and fetal pathologists to deliver study success
State-of-the-art, AAALAC-accredited facilities with high animal welfare standards ensuring the integrity and reliability of your studies
There is well established evidence that some chemicals can impact the sexual function, fertility and development of animals. As scientific knowledge and technology advance, regulators demand new types of data derived from studies that minimize animal use in line with the 3Rs— Replacement, Reduction, Refinement. Developmental and reproductive toxicology (DART) is therefore still an evolving field which is under constant public scrutiny.
DART studies often need multiple groups of adults and off-spring and a large range of varied endpoints. More complex studies, like OECD 443, have additional breeding phases that can be triggered by effects observed during the conduct of the study which adds to the already complicated nature of the study. You will be investing a lot in DART studies, so you need to be confident of reliable outcomes that will satisfy regulatory requirements.
Behavioral, histopathological, anatomical and chemical endpoints can be required for DART studies. You need a validated team with the necessary expertise, facilities and equipment to conduct these assessments. Analytics in offspring and fetuses can be difficult as chemical assays must detect the low concentrations that occur in young animals. This is especially problematic for thyroid hormone testing for endocrine disruptor endpoints. In addition, it is important to ensure Historical Control is available for newer tests like endocrine disruptor endpoints.
DART studies are complex because they involve the mating of animals and management of multiple groups of adults and offspring. As the day of mating during the pairing period varies, DART study logistics can be unpredictable. The study start may span several days and involve peaks in test requirements related to peaks in mating and littering. This can cause you serious resource challenges over the course of a study.
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We understand the importance of DART studies to the commercial success of your chemical. We’ll work in partnership with you to help you meet all your regulatory DART requirements in a cost-effective way. That means using the scientific creativity and strategic insight of our study directors and regulatory experts to design and plan joined-up study programs. Our expert study planners and specialized reprotoxicology animal technicians will execute your study efficiently and to high animal welfare and GLP standards. Regardless of your DART needs, we can help tailor a solution suited to you.
Our expertise in histopathology, animal behavior and analytics, means our team is equipped and capable of assaying all DART endpoints. As leaders in many DART assessments, for example, thyroid hormone analytics, you’ll benefit from our scientific insight and innovative approaches.
Our dedicated teams can conduct a suite of DART studies including:
Our dedicated teams can conduct a suite of DART studies including:
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