Bringing a new drug or medical device to market can take 20 years and cost as much as $1 billion. Research, product development, and clinical trials involve not only the sponsor's staff, but regulators, physicians, academic researchers, and patients. Throughout the process, information systems managers must maintain the flow of data between researchers and sponsors, as well as to the world's regulatory bodies. Experts in health economics and other fields analyze the market into which the product will be introduced. Specialists in preclinical evaluation, clinical trial design and implementation, and biologics production all play significant roles.

This lengthy, expensive, and complex process is broken into several stages. The first, called pre-clinical research, lasts one to three years and tests the drug in animals. If these tests indicate the product is safe, human clinical trials begin.

• During Phase I of human trials, the drug is tested on perhaps 20 to 80 healthy individuals. These tests determine the drug's basic safety and pharmacological data. Phase I lasts an average of six months to one year.
  
  
• Phase II involves testing with around 100 or 200 patients who suffer from the disease or condition the drug is meant to address. Phase II usually lasts between one and two years.
  
  
• Phase III is broken into two segments: Phase IIIa trials test the drug with several hundred to several thousand subjects to verify efficacy and safety on a larger scale. Generally lasting two to three years, Phase IIIa focuses on regulatory issues and is conducted at a variety of sites.
  
  Once Phase IIIa is complete, the drug's sponsor submits all pre-clinical, pharmacologic, efficacy, and safety data to local regulatory agencies. Information on the drug's composition and plans for producing, packaging, and labeling are also included. The resulting regulatory review can take up to 30 months to complete, sometimes more, depending on the country and type of drug.
  
  Meanwhile, Phase IIIb trials begin. Involving a large number of patients, Phase IIIb focuses on issues such as cost-effectiveness and efficacy compared with approved drugs in the same therapeutic class or that are used to treat the same disease.
  
  
• After the product has received regulatory approval, Phase IV trials begin. These address the safety and efficacy of uses beyond the drug's original application, test different dosage strengths and formulations - for example, a sustained release capsule or a flavored solution for children - or confirm extra-clinical benefits such as cost-effectiveness or improved quality of life. Phase IV trials also collect and analyze long-term safety data on patients treated in normal practice.