CRO / IRB

If you are developing a drug, biologic, or medical device, you are likely familiar with contract research organizations and institutional review boards. We help IRBs and CROs understand compliance issues. We also help sponsors understand the important roles that CROs and IRBs will play in the development of your product.

Contract research organizations are able to provide vital services for sponsors of medical products including monitoring and auditing clinical trials, packaging and distribution of investigational products, and statistical analysis of results.  Institutional review boards are charged with ensuring the rights and safety of experimental subjects.

• Draft And Negotiate Contracts Between Sponsors And CROs
• Help Sponsors Evaluate Troubling CRO Monitoring Or Audit Reports
• Assist CROs In Conducting Audits
• Draft Informed Consent Forms In Compliance With FDA And HIPAA Regulation
• Write Effective Standard Operating Procedures For CROs and IRBs