Medicine Clinical Trials Office (MCTO)

The Medicine Clinical Trials Office (MCTO) currently manages more than 100 clinical trials within the Department of Medicine at the Icahn School of Medicine at Mount Sinai. Working closely with institutional committees, including the Program for the Protection of Human Subjects ( human-subjects), the MCTO maintains compliance with all institutional, state and federal regulations throughout the course of each study. The administrative infrastructure of a Clinical Trials Office allows our investigators to obtain approval for studies in a timely manner and supports institutional compliance with regulatory requirements. Additionally, Principal Investigators and their research teams are thereby able to focus on the scientific rigor and patient care side of research.

Specifically, the MCTO provides comprehensive services to support clinical investigators with:

  • Document preparation and submission to internal Department of Medicine Protocol Review Committee.
  • Protocol feasibility determination in collaboration with Investigators.
  • Financial Management throughout the lifecycle of the study.
  • Collaboration with sponsors and/or contract research organizations to prepare all pre-award documentation, including regulatory submissions.
  • Centralized processes and resources through 4 Core Teams: Regulatory Compliance, Financial Management, Clinical Coordination, and Research Operations.
  • Investigator Initiated Trial (IIT) development, activation, and management.

The Clinical Trials Office consists of Regulatory Compliance, Financial Management, Clinical Coordination, and Research Operations.

The Mount Sinai Health System (MSHS); Department of Medicine Protocol Review Committee (PRC) reviews all industry sponsored clinical studies conducted under the auspices of MSHS, regardless of whether the research involves use of the DOM Clinical Trials Office shared resources or not. All new protocols are reviewed and must receive full PRC approval in addition to the Program for Protection of Human Subjects (PPHS) approval before they can be activated. Ongoing studies will be monitored for protocol accrual.

The purpose and rationale for the establishment of a Protocol Review is to provide a process by which the quality and scientific value of clinical research studies are assessed and conducted at the Mount Sinai.

PRC Policies and Procedures


The MCTO has conducted over 600 clinical trials since 2004. The CTO staff have successfully implemented and coordinated many large, multi-centered clinical trials. The impressive investigator panel includes specialists conducting trials in numerous therapeutic areas. The site is well equipped to perform Phase 1 through Phase 4 studies, including first-in-human PK and PD protocols.

Research Experience

The CTO has conducted Phase I-IV studies in the following areas:


  • Diabetes
  • Obesity


  • Difficile Infection
  • Crohn's Disease
  • Irritable Bowel Disease
  • Pouchitis
  • Ulcerative Colitis
  • Fistulas


  • Cushing’s Disease
  • Hereditary Angioedema (HAE)
  • Primary Immunodeficiency (PID)
  • Urticaria

Infectious Diseases

  • Bacteremia
  • Human immunodeficiency virus (HIV)
  • COVID-19

Liver Disease

  • Autoimmune Hepatitis (AIH)
  • Drug Induced Liver Disease (DILD)
  • Hepatitis B Virus (HBV)
  • Hepatitis C Virus (HCV)
  • Nonalcoholic fatty liver disease (NAFLD)
  • Nonalcoholic Steatohepatitis (NASH)
  • Primary Biliary Cholangitis (PBC)
  • Primary Sclerosing Cholangitis (PSC)

Pulmonary Disease

  • Asthma
  • Chronic Obstructive Pulmonary Disorder (COPD)
  • Interstitial Lung Disease (ILD)
  • Interstitial Pulmonary Fibrosis (IPF)
  • Nontuberculous mycobacteria (NTM)
  • Sarcoidosis
  • Post-COVID Sequelae


  • Chronic Kidney Disease
  • Focal Segmental Glomerulosclerosis
  • Lupus Nephritis
  • End Stage Renal Disease


  • Amyloid Disease
  • Lupus Erythematosus
  • Rheumatoid Arthritis

Research Staff

  • 31 Clinical Research Coordinators, 3 Clinical Trial Managers, 2 Research Nurses, 1 Research Dietician
  • 2 Regulatory Compliance Coordinators, 1 Senior Regulatory Compliance Coordinator, 1 Regulatory Compliance Associate, 1 Regulatory Compliance Manager
  • 1 Finance Associate, 2 Financial Analysts, 1 Finance Manager
  • 2 Project Coordinators, 1 Research Program Coordinator, 1 Data Manager, 1 Program Manager
  • All staff have applicable clinical research certifications, and experience using a wide variety of systems for Electronic Data Capture, electronic patient reported outcome devices and apps ("ePROs"), Interactive Voice Response System (IVRS), and Interactive Web Response System (IWRS)
  • Current Investigators

Diagnostic/Clinic Equipment

  • Vital Sign Equipment (BP, Temperature, Respiratory Rate, Pulse Oxygen)
  • Calibrated weight scales (analog and digital)
  • ECG machines
  • Lab drawing and processing equipment
  • Centrifuges (Ambient & Refrigerated)
  • Freezers (0, -20, and -80 degree Celsius)
  • Access to Dry Ice
  • Extended stay capability-infusion rooms

Investigational Drug Service

  • Limited access, secure area with temperature controlled environment
  • Refrigerators and freezers are temperature monitored and alarmed
  • Dedicated research staff who perform accountability according to sponsor specifications

Learn more

The Staff directory is below:

Medical Director: Linda Rogers, MD
Tel: 212-241-5656

Senior Director: Michele Cohen, MS, CCRC
Tel: 212-241-7734

Director, Renalytix Program: Catherine Sinfield, PhD, MPH
Tel: 212-824-7746

Program Manager: Asher Leviton
Tel: 347-920-1830

Regulatory Compliance Manager: Nicole Lewis, CCRC
Tel: 212-241-0639

Finance Manager: Simon Luk
Tel: 212-241-7556

Clinical Trials Manager: Sari Feldman, MSW
Tel: 212-824-7669

Clinical Trials Manager: Ani Cotarlan, BPharm, MS
Tel: 917-583-0037

Clinical Research Manager: Tanjina Razzaque
Tel: 646-286-0194