Post-marketing research (Phase IV trials) is necessary for many products; however, many life sciences companies are falling behind in completing their Phase IV trials on time.
What can they do?
To remedy this, many companies are allowing their medical affairs department rather than clinical development to take over their Phase IV clinical trial management.
How does that help?
This way, the Phase IV trials will get the attention they deserve; whereas, under clinical development, they are often pushed aside for other priorities. Under medical affairs, the trials will also be unified under one roof of communication. The team can plan and conduct the trials while gaining post-marketing information.
So, clinical development only needs to worry about Phase I, II, and III. Medical affairs can take over Phase IV, in addition to their less taxing Health Economics Outcomes Research and information system management duties.
For more information on issues like this, contact the Kulkarni Law Firm.