Lifespan ClinTECH
Clinical, Translational, Environmental, and Community Health Center
Regulatory Services
The ClinTech regulatory support team can help you improve your clinical trials processes and the responsible conduct of human subjects research through interaction with local, state, and federal agencies.
Regulatory Areas of Focus
- Institutional Review Board (IRB) assistance: protocol development, form completion, consent forms
- Working with single IRBs to comply
- NIH requirements for multi-site clinical trials
- Data and Safety Monitoring Board (DSMB)
- Consultations regarding master contracts, FDA Investigational New Drug (IND) and Investigational Device Exemptions (IDE) filings
- Investigator training
- Patient recruitment