Our product suite for commercial supporters helps our clients meet critical requirements to document the compliance of their independent medical education (IME) activities with established regulatory guidance.
Supporters of IME must adhere to industry guidelines relative to standards of commercial support across all activity types. According to the Office of the Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers:
- Pharmaceutical manufacturers should have no control over the speaker or content of the educational presentation.
- Compliance with such procedures should be documented and regularly monitored.
Additionally, Corporate Integrity Agreements (CIAs) have required some supporters to have additional compliance monitoring systems in place.
Our turn-key services offer you the confidence to ensure that:
- Educational activities supported by your company are consistent with the grant request, compliant with accreditation standards, abide by regulatory guidelines, and meet all appropriate codes of conduct
- Your Corporate Compliance Program monitoring requirements and specific Corporate Integrity Agreement (CIA) requirements, if applicable, are being satisfied
- Your educational activities can be benchmarked against our historical database
We’ll help you monitor the full range of educational activities you support, including:
- REMS Activities
- Satellite Symposia
- Large Multi-session Conferences
- Enduring Materials
- Patient Education Materials
Our current suite of services includes three rigorous approaches to achieving the above objectives: