BSSI supports clients throughout the testing and development of biosimilars. With broad experience in this highly diverse field, BSSI is well versed in the distinct requirements for these products.
- Experimental study design
- Analytics for screening, optimization and validation
- Assay analytics including validation
- Equivalence testing
- Clinical protocol and study design, including sample size determination and randomization
- Statistical analysis plans
- Results reports including summary of safety and efficacy findings