# RhoFED CDSMC

> **NIH NIH U01** · RHO FEDERAL SYSTEMS DIVISION, INC. · 2024 · $256,112

## Abstract

PROJECT SUMMARY/ABSTRACT
Type 1 diabetes (T1D) is a debilitating autoimmune disease in which the body attacks and destroys the
pancreas’s ability to make insulin. It can cause long term damage to or even failure of various other organs,
leading to irreparable injuries such as blindness, amputation, and stroke. The NIAID Clinical Data and Safety
Management Center (CDSMC) currently provides support for 2 T1D studies. This support includes safety
monitoring and reporting, data management, and randomization support, all of which are key components to
designing and conducting studies that answer research questions important to NIAID. Rho Product Safety
takes the lead on reporting serious adverse events occurring in participants enrolled in these studies, both to
NIAID and appropriate health authorities, to help ensure the safety of participants. Data management creates
and maintains data collection systems that support data entry and cleaning study clinical research data.
Randomization support is provided using fully validated, 21CFR11-compliant self-service web-based study
configuration interface that supports a variety of randomization schema.

## Key facts

- **NIH application ID:** 11110962
- **Project number:** 3U01AI178773-02S1
- **Recipient organization:** RHO FEDERAL SYSTEMS DIVISION, INC.
- **Principal Investigator:** Peter N. Schmidt
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $256,112
- **Award type:** 3
- **Project period:** 2023-05-08 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11110962

## Citation

> US National Institutes of Health, RePORTER application 11110962, RhoFED CDSMC (3U01AI178773-02S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11110962. Licensed CC0.

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