Case Studies

Opportunity: Conduct ingredient safety assessments leveraging next generation tools. Fill data gaps for new ingredients lacking existing literature for assessing safety. Apply next generation approaches appropriately and proficiently to inform on potential safe use of new ingredients. Challenges: Perform systematic review for data and literature [...]

Opportunity: Perform toxicological assessments with cerebral spinal fluid (CSF) collected at termination Challenges: Ensure that RNA from CSF and tissue samples are of high quality and free of hemolysis, and that tissues have an RNA integrity number (RIN) greater than 8.5. Weigh and preserve eight [...]

Opportunity: Conduct in vivo studies involving submandibular injections of a gel-forming product. Previous efforts by the incumbent CRO had not met client expectations, specifically related to the quality and reproducibility of the results. The client was also confronted with a broad inability among providers to [...]

Opportunity: Conduct thorough search of publicly available literature to identify data that could impact human health or environmental risk assessments for genetically modified organisms. Submit evaluation results in the proper format and within the time requested. Challenges: Develop evaluation strategy that would meet client expectations. [...]

Opportunity: Conduct an expedited micronucleus (MN) assay in mice and comet assay in rats. Challenges: 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 [...]

Opportunity: Evaluate Tox21 and/or ToxCast high-throughput screening data for food-use chemicals using computational toxicology methods and in-house expertise. Clearly communicate data and analyses in reports and presentations. Identify, highlight, analyze and explain the most important findings from within a broad data set. Challenges: Identify and [...]

Opportunity: Thoroughly document and interpret the histopathologic effects resulting from exposure of an emerging occupational hazardous agent in wild type and genetically modified mice, focusing on the potential of the agent to induce both neoplastic and nonneoplastic lesions following long-term exposure. Deliver a clear, concise [...]

Opportunity: Extract RNA from human FFPE tumors to support development of novel chemotherapeutic agents. Accurately and thoroughly identify neoplastic cells in submitted tissue samples to recover sufficient RNA. Challenges: Process a large number of submitted samples with very short lead time. Adhere to extremely tight [...]

Opportunity: Test whether the genotoxicity observed following administration of a commonly used herbal supplement (reference extract) to mice and rats was potentially related to folate deficiency induced by the supplement. Use an in vitro micronucleus assay to investigate a possible mechanism of action for a [...]

Opportunity: Design a study to assess the mode of action (MOA) that leads to tumor development in rodents exposed to acrylamide. Publish data in the peer-reviewed literature. Provide data for use by international regulatory agencies as part of risk assessments. Challenges: Design an experiment identifying [...]