There are many governing bodies that require independent oversight of safety, post market surveillance, patient outcomes, and medical education. These primary governing bodies include the FDA (drugs, biologics, & devices), Centers for Medicare/Medicaid Services, and as of March 2008- Standard and Poor’s. With the signing on September 2007 of the Food and Drug Administration Amendments Act of 2007 (FDAAA2007) congress has expanded authority to the U.S. Food and Drug Administration (FDA) and commands comprehensive, objective risk-mitigation activities and post-market safety surveillance from pharmaceutical, biotech, and medical device companies.
WATERMARK started by providing independence IDMC and adjudication panel services. Today we still provide those core services but have also expended into niche risk-mitigation offerings for the pharmaceutical, biotech, and medical device industry. Because of our roots in the regulatory arena, we ensure all services we provide will keep the pharmaceutical, biotech, and medical device companies in compliance and are part of a comprehensive risk-mitigation strategy. With an ever changing regulatory environment, it is critical to have a partner that understands the guidelines and has the experience to support programs.
For information on our offerings, please select a link below:
During a Clinical Trial
- Independent Data Monitoring Committees (IDMC)
- Adjudication Panels
Post- Market Offerings
- Post-Market Safety Oversight (SOAR)
- Outcome Registries- development and administration (I-CARE)
- Speaker Bureaus
- Document Libraries
- Gift/Promotional Registries
- Medical Science Liaison Programs
- Compliance Training (OIG, PhRMA Code, AdvaMED, HIPAA, more…)
Additional Information
- Articles and Press Releases
- Contact Information
- Corporate Overview
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| Watermark Research Partners was recognized as one of the top 20 Woman Owned Business in the State of Indiana and one of the top 500 Woman Owned companies in the country for 2008.
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