# Investigational Drug Service Shared Resource

> **NIH NIH P30** · ROSWELL PARK CANCER INSTITUTE CORP · 2021 · $83,381

## Abstract

The goal of the Investigational Drug Service Shared Resource (IDS) is to provide a centralized resource for
comprehensive pharmacy support for all Clinical Investigators and patients enrolled in clinical trials at Roswell
Park. IDS establishes and implements processes and procedures that ensure study drug use is in accordance
with all federal, state, institutional, and sponsor regulations governing clinical research. The IDS provides a
wide array of services tailored to the clinical protocol-specific needs, including critically important services to
Roswell Park CCSG members that ensure regulatory rigor, high quality pharmacy services and including
preparation of investigational agents, and safety of clinical trial participants. The IDS is critical for facilitating the
conduct of treatment intervention clinical trials by maintaining regulatory rigor and subject safety. IDS has
been delegated all aspects of investigational drug management in order to ensure safe provision of study
medications to research subjects enrolled in treatment intervention clinical trials. Importantly, IDS leadership
and staff are members of the Early Phase Clinical Trial (EPCT) unit and can support the development of all
early phase translational trial development. In conjunction with Dr. Robert Bies (Bioanalytics, Metabolomics &
Pharmacokinetics Shared Resource), who is also a member of EPCT, IDS supports development of clinical
pharmacology aspects of CCSG program protocols. In the reporting period (2013-2017), the IDS served a total
of 73 Roswell users, of which 44 (60%) were CCSG members. The Specific Aims of the IDS are: 1) To
evaluate treatment intervention clinical trials for feasibility and facilitate protocol review: IDS participates in the
PRMS process for all treatment intervention clinical trials; 2) To manage investigational agents for all treatment
intervention clinical trials in accordance with Good Clinical Practice (GCP) standards: IDS has developed
standard operating procedures for ordering, receiving, storage, dispensing, preparation and destruction of all
study medications; 3) To provide clinical services essential for safety of patients participating in treatment
intervention clinical trials: IDS pharmacists ensure patient safety by (i) assessing for potential drug interactions
with investigational agents; and (ii) providing education for patients taking investigational agents at home to
ensure patient safety and data integrity. In alignment with Roswell Park's strategic plan to enhance innovative
cancer care especially in immunotherapy and precision medicine, it is anticipated that the complexity of
treatment intervention clinical trials will continue to increase over the next five years.

## Key facts

- **NIH application ID:** 10148656
- **Project number:** 5P30CA016056-44
- **Recipient organization:** ROSWELL PARK CANCER INSTITUTE CORP
- **Principal Investigator:** Barbara Todaro
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $83,381
- **Award type:** 5
- **Project period:** 1997-06-16 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10148656

## Citation

> US National Institutes of Health, RePORTER application 10148656, Investigational Drug Service Shared Resource (5P30CA016056-44). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10148656. Licensed CC0.

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