ABSTRACT
This chapter examines the interlinking complexities of research and development programme management within the pharmaceutical industry. It explains approaches for dealing with potential challenges and for delivering robust and auditable data to support product registration. In order to understand the complexities of programme management in the pharmaceutical industry, it is import to have a full understanding of the specific stages of each step of drug development and the outputs required from each step. Clinical pharmacology studies are conducted in the clinical setting involving human beings. They follow a strict process from phase I to phase III trials, designed to support registration of the drug for use on global markets. Many pharmaceutical companies outsource their phase III trials to a contract research organization (CRO). Leading CROs generally have the country infrastructure to support global phase III programmes across multiple indications, thus assuring that the sponsor is able to assess the efficacy and safety of their product in many ethnicities.
