The RADARS System aids in development of postmarketing surveillance studies required to meet regulatory and business needs, including formal study protocols and statistical analysis plans.
Assistance with development of formal epidemiological study per FDA guidance, FDA Advice Letters, and good pharmacoepidemiological practices.
Advisory Board Participation
The RADARS System provides consultation on strategy and risk management approach related to prescription drugs with abuse potential.
Advisory Committee Consultation
RADARS System offers consultation services as clients prepare for U.S. Food and Drug Administration Advisory Committee meetings.