Clinical Research - For Sponsors

Overview

The Institute for Clinical Research at Holy Name Medical Center provides investigators, facilities and services that seek to advance patient care through clinical research. High quality clinical trials are conducted to test new medications, devices, diagnostic modalities and treatment protocols. Because of the Institute's size and scope, it can offer sponsors high quality data and accruals more expeditiously and efficiently than academic clinical research centers.

The Institute is currently conducting both inpatient and outpatient Phase II - IV studies in multiple therapeutic areas in a state-of-the-art facility that meets regulatory and industry standards.

The Institute provides:

• Dedicated research staff & units
  • Central Clinical Research Unit (CCRU)
  • Oncology Clinical Research Unit (OCRU)
  • Clinical Research Nurse Managers
  • Clinical Research Nurse Coordinators
  • Certified Clinical Research Coordinators – CCRC
  • Dedicated Research Pharmacists

• Physician-Investigator Pool
  • Access to a medical staff of several hundred board certified physicians in all the major medical and surgical specialties
    • Well–trained investigators in CITI training
    • Participation in the Shared Investigator Platform

• Track record of high recruitment & retention into clinical trials

• Dedicated research laboratory & continuously monitored refrigerator/freezers (-80)

• Dedicated binder storage that meets federal & industry requirements

• Dedicated study monitor space

• Dedicated patient rooms with calibrated equipment
  • Access to outpatient infusion suites
  • On-Site imaging services
  • Local state-of-the-art hospital laboratory

• Research Quality Assurance & Improvement Program
  • Focus on data quality and integrity
  • Not-for-Cause and For-Cause auditing

• Human Subjects Research Program
  • Regulatory oversight
  • Central & Local IRBs

• Central Research Administration
  • Centralized start-up
    • Efficient and streamlined single point of contact for budgets, contracts, and regulatory submissions
  • Research Finance
  • Electronic Remote Management System
    • Clinical Trials Management System
    • Electronic Binders – [e-Reg]
    • Remote EMR access for monitors