Genetics Clinical Trials Office

The Department of Genetics and Genomic Sciences at the Icahn School of Medicine at Mount Sinai is paving the way for the future of genomic research and medicine at the largest and most diverse health care system in New York City. The Division of Medical Genetics has a substantial history of translational work and conducting clinical trials for patients with rare genetic disorders. Many of Mount Sinai’s clinical trials have led to approval of new treatments for patients by the Food and Drug Administration (FDA).       

The Clinical Trials Office (CTO) in the Department of Genetics and Genomic Science aids sponsors (industry, foundations) and investigators with navigating and conducting clinical research studies.

To date, we have performed more than 50 industry, National Institutes of Health, and investigator initiated studies. Our studies include groundbreaking DNA, RNA, and enzyme based therapies. We are committed to developing advancements in genetic medicine by offering new therapeutics to patients with rare genetic disorders.

Study Services

We have executed all types of clinical research studies. Whether your study is observational, a first-in-human trial, or a phase III pivotal trial, our team will help get you through start-up to closeout efficiently.

Our services include:

  • Completing confidential disclosure agreements
  • Conducting feasibility assessments
  • Protocol design
  • Coordinating site qualification and site initiation visits
  • Negotiating clinical trial agreements and study budgets
  • Providing research staff to successfully execute the study
  • Conducting regulatory submissions
  • Training study personnel
  • Promoting recruitment and retention of study subjects
  • Resolving operations or regulatory issues
  • Facilitating monitoring and audits, including FDA audits

 

Visit the intranet for information on internal investigator-initiated studies and contact the CTO Director at the Department of Genetics and Genomic Science to initiate a new study. The Office of Research Services outlines the details for industry initiated clinical research at the Icahn School of Medicine.