# CLINICAL TRIALS MONITORING SERVICE

> **NIH NIH N01** · THERADEX SYSTEMS, INC. · 2024 · $8,245,870

## Abstract

This is a Research and Development Support contract.  The purpose of this acquisition is to assist the NCI in fulfilling its responsibilities to the Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) regulations as IND sponsor and funding agency.  The scope of the Clinical Trials Monitoring Service (CTMS) contract is to provide data management, quality assurance, clinical trial monitoring, and auditing capability for NCI sponsored clinical trials conducted by the NCI's Experimental Therapeutics Clinical Trials Network (ETCTN) at participating sites both domestically and internationally.  Additionally, the CTMS contract provides a mechanism for the auditing of biopharmaceutical manufacturing facilities to ensure compliance with current Good Manufacturing Practices (GMP) and compliance with Good Laboratory Practices (GLP) for laboratories performing integral assays.

## Key facts

- **NIH application ID:** 11082958
- **Project number:** 75N91022C00013-P00005-9999-1
- **Recipient organization:** THERADEX SYSTEMS, INC.
- **Principal Investigator:** BARRY ANDERSON
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $8,245,870
- **Award type:** —
- **Project period:** 2024-05-01 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11082958

## Citation

> US National Institutes of Health, RePORTER application 11082958, CLINICAL TRIALS MONITORING SERVICE (75N91022C00013-P00005-9999-1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11082958. Licensed CC0.

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