Pediatric Clinical Trials Office

THE MINDICH CHILD HEALTH AND DEVELOPMENT INSTITUTE

The Pediatric Clinical Trials Office within The Mindich Child Health and Development Institute has emerged as a pivotal resource, addressing the research needs of investigators within the Mount Sinai Health System, particularly in the realm of pediatric clinical trials. Its inception in the aftermath of the pandemic surge in Fall 2020 underscores a strategic response to the evolving landscape of health care challenges.

A notable aspect of the Pediatric Clinical Trials Office's operational framework is its collaboration with the Clinical Trials Office in Internal Medicine. This collaboration extends its purview to the adept management of a spectrum of trials, encompassing investigator-initiated, industry-funded, and federally funded endeavors. Of particular interest is the Pediatric Clinical Trials Office’s commitment to facilitating extension trials, wherein the studies extend seamlessly from adult to pediatric populations. This nuanced approach speaks volumes about the adaptability and foresight in catering to the intricacies of diverse clinical research challenges.

Explore the Pediatric Clinical Trials Office

The objective of the Pediatric Clinical Trials Office is to provide research infrastructure for the process of moving projects from initial proposal through contract execution/internal review board approval. This includes review and execution of confidentiality disclosure agreements, cost and feasibility analysis, budget development and contract execution. In addition, this office provides ongoing financial, regulatory, and study oversight for all clinical trials.

Our services encompass assisting researchers in the Department of Pediatrics with a wide range of tasks, including:

Protocol feasibility determination in collaboration with investigators and senior leadership
Negotiating study budgets and contracts with sponsors
Providing 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 four core teams: Regulatory Compliance, Financial Management, Clinical Coordination, and Research Operations
Investigator-initiated trial development, activation, and management
Overseeing coordinator activities, including onboarding, cross-training, and mentoring

Happening Now

1425 Madison Ave, Room L3-90

New York, NY 10029

212-659-9443

Eyal Shemesh, MD

Michele Cohen, MS, CCRC

Yair Bitton, MBA, MPH, CCCRP

212-659-9443

Xueru Mu, CCRP

212-659-9423

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