Mr. Belson frequently advises clients on drug clinical trials, both in the U.S. and internationally. He has been the primary or sole legal advisor on numerous clinical trials, including multiple Phase III studies. He assists clients in setting up and operating all phases of clinical studies. His experience covers numerous therapeutic areas, including neurological, cardiovascular, addiction treatments, oncology and rare genetic disorders.
Mr. Belson’s clinical trial experience includes the following:
- Negotiating agreements with Contract Research Organizations (CRO’s) and involving individual clinical trial sites
- Preparing agreements with manufacturers, packagers, sample storage facilities, software firms, biostatisticians and others who support clinical trials
- Negotiating agreements with Institutional Review Boards (IRBs)
- Reviewing informed consent forms for clinical trial subjects
- Advising clients on HIPAA and other data privacy matters affecting clinical trials
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