The bioequivalence team is involved from protocol development through to the completion of clinical trial reports for regulatory submissions.
Royal International boasts a skilled team, with staff trained to international standards for conducting clinical studies.
The Bioequivalence team includes:
Clinical Operations Department: Spanning over 4500 sq. m., this state-of-the-art facility can accommodate more than 150 subjects. This department conducts the clinical phase of bioequivalence studies for Royal International. Responsibilities include recruiting healthy volunteers, performing screening activities such as counseling, collecting and summarizing screening data, and ensuring proper follow-up on abnormal medical results. They manage overall study operations, including safety monitoring, clinical data collection, protocol writing, study design, case report form creation, ethics committee submissions (protocols, CRFs, ICF), adverse event monitoring, and report preparation.
Bioanalytical Laboratory Team: This team performs assays for drugs and/or their metabolites in pharmacokinetic studies. They excel in developing and validating complex methods ahead of business requirements, with expertise in protein precipitation, liquid-liquid extractions, solid phase extractions, and derivatization techniques.
Pharmacokinetics Team: Responsible for designing bioequivalence studies based on the pharmacokinetics of the study drug, and writing bio-study protocols. Their expertise includes designing and managing data for multiple dose studies, parallel design studies, reference replicated design studies, and PK/PD studies.
