Report Abstract
A review of all regulatory activity in the area of clinical
development provides insights into compliance risks. This information can be used to:
- Evaluate and review risks for clinical investigators and CRO's
- Develop effective strategies for managing clinical initiatives
- Establish improved monitoring programs
- Ensure proper investigational review board (IRB) involvement and review
- Effectively report key clinical information to regulatory authorities
Commonalities exist in regulatory activity for drugs, biologics and
devices regarding causes of regulatory citations. These commonalities further highlight areas of ongoing risk for clinical
research/development and provide a means of proactively addressing clinical process gaps. Additionally, regulatory trends
highlight areas of concern for clinical investigators and CRO's. This provides sponsors with greater insights into the regulatory
risk of organizations whose services are outsourced as part of clinical.....
Report is 11 pages of value added, informative compliance details. Price $125.00.
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