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GLP Preclinical Study CROs evaluate drug candidates for safety and efficacy during the animal testing mandated by the FDA. Preclinical research services entail comprehensive in-vivo testing for PK/TK, toxicity, and biomarker endpoints before initiating first-in-human clinical trials. For example, Preclinical CROs offer dose range finding and repeated dose toxicity studies crucial for your IND application package. NorthEast BioLab provides high-value bioanalysis and preclinical research services to top biotech companies and academic institutes. Tap our veteran team to benefit from our experience of delivering excellent Preclinical Research Services on 100+ studies.
What is a Preclinical Study CRO?
Preclinical Study CRO: From Proof-of-Concept (POC) to IND Submission
Preclinical CRO is a support center offering expertise in research and development necessary for navigating a drug candidate through animal testing and advancing it into the clinical phase. Preclinical research services involve several studies critical to asses drug efficacy and safety in animal models and complete Investigational New Drug (IND) filing studies. Successful completion of the drug IND package is the first milestone towards clinical development.
Many drugs are rejected during the preclinical stage due to subpar treatment effects or adverse outcomes including toxicity. If these studies are not appropriately designed, your medication can be dismissed by the regulatory authorities in error. Hence, it is imperative to look for a preclinical CRO with competent personnel who have relevant scientific expertise as well as regulatory awareness.
Before a drug could be released in the market, a set of studies are conducted to predict its safety and efficacy in humans. These clinical studies are often conducted following intensive animal studies under the supervision of pharmaceutical scientists and experts. This animal testing must follow the ethics and regulations set for animal use in preclinical research. First in man study is designed based on the preclinical studies including first safe dose in phase I study.