Cross discipline review and guidance on pharma, biotech, med-tech products requires cross functional skills and expertise.
During the review we includeanalysis of target or disease condition, current treatment options. Analysis of product quality/raw materials, adequacy of manufacturing.
Analysis of general nonclinical pharmacology/toxicology information to support the claims. General clinical pharmacology such as generated or known information on absorption, distribution, metabolism, and excretion, drug-drug interactions, pharmacodynamic considerations.
Clinical/statistical analysis for claimed or targeted efficacy, including protocol evaluation for adequacy of study designs, study population, baseline characteristics, endpoints for efficacy/safety, and appropriateness of tools used and statistical methods.
