What is Phase IV clinical trial?

Phase IV studies, often called Post Marketing Surveillance trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.

Phase II/IV 

You have spent millions of dollars and years of hard work bringing your product to the drug development process. Phase II - Phase IV clinical trial requires significant investment that you want to guard by choosing right CRO partner. From randomized to double-blind, placebo-controlled studies or other designs - for simple or complex trials - Clintrac team of experts is prepared to conduct your project on-time and on-budget.

Clintrac focuses in the planning management, implementation, and analysis of Phase II-IV clinical trials, ranging from small studies to multifaceted, multinational projects. We be acquainted with your exceptional needs and acclimatize to meet them.

One of most considerable differences between Phase I-III and Phase IIIb/IV trials is the need to enroll significantly larger numbers of patients for the late-phase studies to produce the required volume of data. While a Phase III trial might include as few as 1,200 patients and less than 80 sites, a Phase IV safety or marketing study could encompass 4,000 or more patients at hundreds of sites. We have conducted a vast number of Phase II/III studies in a comprehensive scope of therapeutic areas like Oncology, Respiratory, CNS, Cardiovascular, Diabetes etc.

We've structured ourselves as a customer-centric organization with a very perceptible and involved senior leadership team to adapt processes to deliver on your objectives cost-effectively.