mKnal Global Solutions offer service "Clinical Development"

Provides end-to-end project and clinical management for biostudies, including CRO capacity assessment and qualification, full product assessment to gauge clinical and regulatory complexity, protocol review with recommendations on study design, statistics, and sample size, technical/scientific rationale for clearing regulatory hurdles, execution and management of Paragraph IV (first-to-file) bioequivalence waiver strategies, clinical data monitoring and quality assurance, bioanalytical audits and data verification for method development/validation and bioanalysis, and review of clinical reports for compliance.