Compliance Program Management
In today's environment all companies should have a functioning compliance program. For smaller organizations these requirements need not be onerous and can be managed with part-time resources.
Fairmark works with clients in the later stages of clinical development to design and implement effective compliance programs in preparation for commercial launch.
Do we need compliance now?
Whistle blower lawsuits are pervasive
Government is looking for individuals and companies to prosecute as examples
Prosecutors have focused on both large and small companies
Functioning compliance program is expected by prosecutors
Most whistle blowers turn to the government only after first trying to address concerns with the company
COMPLIANCE PROGRAM
SERVICES
Compliance Program Design
• Code of Conduct
• Key Policies and SOPs
• Training Materials
• Hotline Implementation
• Management Plan
Compliance Program Management
• Employee Training
• Hotline Monitoring
• Annual Risk Assessment & Monitoring
• Investigations & Corrective Action
• Business Team Advise and Support
• Part-time Chief Compliance Officer
• “Sunshine” reporting
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