Abstract: A method of managing a clinical trial where the clinical trial involves a follow-on biological (FOB) substance, the method comprising: receiving subject data at a computer system as the subject data becomes available, the subject data indicating effects of the administration of the FOB substance in the clinical trial; storing the subject data in a database; and making coded data electronically available to an authorised independent monitor, the coded data being based on the subject data and indicating effects of the administration of the FOB substance in the clinical trial but having subject-identifying information omitted therefrom, wherein the coded data is made available once the subject data is stored in the database.