Protocol review
Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions, taking into consideration ethical issues, to ensure data integrity and the safety of trial subjects. Qinecsa’s expert team provides global protocol review services, supported by partnerships with epidemiologists, biostatisticians, and a wide network of consultants and established vendor partners.
Collaborative protocol review to identify and mitigate potential risks early in the drug development process.
Process
Comprehensive protocol management services, authoring, quality review against source documents, and medical review along with scheduling kick-off meetings to facilitate setting up of objectives, processes, and timelines.
Expert team
Proven expertise in preparing protocol synopsis, study design objectives/ endpoints, identify inclusion/exclusion criteria, undertake sample sizing considerations, and statistical planning.
Collaboration
Our experts collaborate closely with sponsors and investigators to ensure that critical milestones are met and there are no study delays or wasted resources.