Preclinical studies must generate the comprehensive data needed for a therapeutic candidate to begin in-human clinical studies. The quality of the information collected from these animal and cell line models is vital for FDA submission and approval. Brooks Life Science Systems offers consulting services that identify the appropriate testing, sample processing, and data analysis methodologies for preclinical studies. We also provide support for the collection, processing, and analysis of those samples, plus storage for archival purposes. As the challenges in preclinical research become increasingly complex, Brooks’ straightforward solutions simplify these problems to ensure the quality of your FDA submissions.
- Researchers identify appropriate molecular, pathological, and cellular analyses for models.
- Proper technology is selected and sample processing is developed and validated.
- Integrated analytical and functional quality control is established.
- Animal or cell line samples are processed and tracked.
Drug Development: Preclinical Research