Facilitating Clinical Research Relationships.
Dennis P. Swanson has over 30 years of academic medical center experience as both a clinical research investigator, in the area of radiopharmaceutical development, and a regulatory compliance officer.
Areas of expertise include:
- Human subject protection programs
- Institutional Review Board (IRB) operations and regulations
- Radioactive Drug Research Committee (RDRC) operations and regulations
- Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications
- NRC regulations (21 CFR Part 35)
- Academic institution issues related to:
- Investigator-industry conflicts-of-interest
- Industry clinical trial contracts/agreements
- Use of external, central IRBs for industry-sponsored clinical trial approvals
- HIPAA Privacy Rule regulations and human subject research
Please be patient as we finalize the development of our website, in the meantime please use the contact information listed below to contact me with questions or information/background request. |