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Phase IV or Post Marketing Surveillance Trials (PMS) are studies which are performed after a drug is approved for sale. Such studies are done to determine if a drug or treatment is safe over time, or to see if a treatment or medication can be used in other circumstances.
Another type of Post Marketing Surveillance Trials are registry studies which determine epidemiology of a disease and ways of standard treatment. The results of such studies are used to determine the need for a certain medication in different areas; this is necessary to begin marketing of an approved drug in a new region, or to begin development of a new drug to satisfy unmet needs of contemporary medicine.
SynRG extensive experience in PMS trials allowed us to analyze a large number of such studies. As a result, we have organized a special department which deals specifically with Phase IV/PMS studies.
All Post Marketing studies are, of course, different, but they have many characteristics in common:
- Limited budgets for both monitoring and data management
- Limited monitoring
- Multiple centers in remote locations
- High patient volume
- Paper CRF and paper query workflow
- Large amount of data to proceed
The characteristics listed above represent challenges in the Phase IV studies management. However, as these studies are mostly surveillance studies (whether or not they deal with the existent drugs or condition surveys), these challenges can be met using the same methodology approaches. Such approaches developed by SynRG Phase Fou® specialists allow our Sponsors to cut time and money in their marketing research.
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