The Mindich Child Health and Development Institute

The objective of the PCTO is to provide comprehensive research infrastructure to support the progression of projects from initial proposal through regulatory approval, study conduct, and ultimately to study close-out. This includes tasks such as reviewing and executing disclosure agreements, conducting cost and feasibility analyses, developing budgets, and ongoing support for study conduct, including clinical operation, financial management, regulatory compliance, and oversight of all aspects of clinical trials.

The PTCO consists of teams specializing in regulatory compliance, financial management, and clinical coordination. 

The Regulatory Compliance Team provides regulatory services that include:

• All Institutional Review Board submissions, which include:

  • Submitting the initial regulatory packet to the sponsor

  • Preparation and maintenance for the electronic regulatory binder

  • Submitting new Program for the Protection of Human Subjects (IRB) applications

  • Interacting with external IRB’s and with sponsor regulatory personnel

  • Preparation of informed consent forms

  • Continuation reports

  • Revisions and amendments

  • Final reports

  • Protocol deviations

  • Serious adverse events

Ongoing maintenance and compliance with the federal, state, and institutional regulatory requirements.

Study monitoring support, and support for auditing needs.

• • The Business Operations Team provides:

    • Budget analysis and negotiations

    • Contract negotiations with institutional policies

    • Grant start-up and ongoing management with institutionally-sponsored projects, officials, division, and department administrators

    • Monthly invoicing to the sponsor

    • Budget renegotiation and contract amendments 

    • Monitoring and management of grant expenses

  • The Clinical Coordination Team consists of clinical research coordinators and clinical research/trial managers, who work closely with investigators and sponsors clinical operations before and during study activation. Responsibilities include but are not limited to:

• Facilitate site qualification visits

  • Working with regulatory for site readiness and study maintenance

  • Attending investigator meeting(s)

  • Assisting investigators with prescreening and recruitment of subjects

  • Performing study/protocol procedures in a detailed, accurate manner

  • Data entry

  • Documenting and reporting adverse and serious adverse event(s)

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

Interested in collaborating with us? Contact us today to learn how we can support your research efforts and contribute to advancing pediatric healthcare.

  PCTO is open to providing support across the entire spectrum of pediatric research and has successfully collaborated with providers in the following therapeutic areas:

• Allergy and Immunology

• Gastroenterology

• Cardiology

• Endocrinology   

• Nephrology

• Infectious Diseases

• Pediatric ICU

• Neonatal ICU

• Rheumatology

• General Pediatrics

• Seaver Autism Center