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The Clinical Trials Overview

1. Research Support

  • Experienced Investigators
  • Protocol Consultation
  • On-site investigational pharmacy
  • Experienced, dedicated, study coordinators

2. Budget/Contract 

  • Staff experienced in creating and negotiating budgets and contracts 

3. Quality Assurance 

  • Compliance with Food and Drug Administration (FDA) and Code of Federal Regulations (CFR) requirements
  • On-site IRB with biweekly scheduled meetings
  • Experienced regulatory affairs coordinator to prepare IRB submissions and maintain regulatory documents
  • Standard Operating Procedures consistent with regulatory requirements
  • Good Clinical Practice (GCP) trained staff with certification
  • Centralized scheduling of meetings for site assessment, initiation, and study monitoring visits
  • Study report preparation and submission
  • Subject Identification and Recruitment
  • Potential participant databases 

4. Research Facilities 

  • Extensive clinical and academic research facilities
  • Dedicated laboratory, monitor rooms, patient exam/treatment rooms and waiting areas
  • Secure research drug storage and dispensing areas 
  • Phlebotomy and laboratory analysis services available

5. Data Management and Reports

  • High quality clinical and research data
  • Secure data storage environment
  • Report and manuscript writing

Our Physicians

Office Locations

  • Dermatology Clinical Research Unit
  • Herbert Irving Pavilion, 12th Floor, Room 1264
    161 Fort Washington Avenue
    New York, NY 10032

  • Tel: 212-305-6953
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  • ©2009. Columbia University Medical Center, Department of Dermatology, New York, NY.