Phase IV

Phase IV Study Solution

A Phase IV study is a clinical trial designed to capture specific information about an approved drug product. These studies may be initiated independently to pursue additional product claims and indications or to capture real-world experience and safety data. In other cases, a post-approval study may be required to address a specific requirement of the FDA.

Phase-IV studies typically involve a broader range of investigator sites than pre-approval trials, requiring a more intuitive and scalable architecture capable of training multiple investigators and delivering results quickly while promoting the level of visibility needed for project managers and monitors to make real-time decisions regarding their research.

Due to recent safety concerns of some marketed products, there has been increased interest to ensure pharmaceutical companies conduct as much research as possible to assess a drug's safety both before and after it enters the market.

Frequently, the scale and breadth of phase IV research can drive up costs considerably. This is especially true in studies involving several hundred investigators and several thousand study subjects. Under these circumstances, TEMPO can dramatically reduce the study costs and management hurdles associated with paper-based data collection methods, and also provides a lower-cost alternative to non-integrated software solutions offered by current vendors.

How TEMPO Can Help

Through TEMPO, our integrated clinical research software platform, Clinipace can balance the needs of sponsors and investigators by providing the complete technology and support infrastructure to collect and manage study data and associated business processes.

• Clinical research solution hosted in top-tier data center
• Study set-up and support
• Data collection and trial management tools
• Reporting
• Logistics/Workflow Management

Benefit to the Site

Phase IV studies commonly utilize practicing physicians who may be first time investigators and new to clinical research. It is important to ensure a good experience for the investigator as well as meet study objectives for the sponsor. TEMPO was designed with both the investigator and sponsor in mind, providing investigator sites with the ability to focus on science and medicine while reducing the administrative issues related to study participation. Other efficiencies provided by TEMPO include:

• IRB communications
• Reduced study monitor site visits
• Increased accuracy
• Adverse event reporting

Benefit to the Sponsor

The most important benefit to the sponsor is the ability to have access to real-time management reports from all sites worldwide. Sponsors using TEMPO can immediately access critical information including: