BASi Clinical Research Unit
302 West Fayette Street
Baltimore, MD 21201 USA
Phone: 410-385-4503
Fax: 410-385-1957
E-mail:
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Center Overview
Clinical Research Experience
Facility Description
Investigator Experience
Staff Expertise
Patient Demographics
Other Information
Contact Information

 

Center Overview

BASi supports Phase I/IIa clinical trials with three separate clinical units with a total of 96-beds, and a 10-bed Critical Assessment/First-in-Man unit, full-service Clinical Trials Management Division, Data Management, Statistics, and Regulatory Report Writing functions, all based in Baltimore, Maryland. The company also offers highly sophisticated GLP and GMP Bioanalytical Services, including 50 LC/MSMS systems, GMP pharmaceutical analysis, methods development and validation, drug safety and ADME studies, as well as stability testing and storage and in-life preclinical and toxicology services.

Clinical Research Experience

Study Focus

  • Drug interaction
  • Bioequivalence
  • Dose escalation
  • Bioavailability
  • Safety and tolerance

Facility Description

First-in-Man Unit

  • 10 beds
  • 10 bedside cardiac monitoring units
  • Continuous 12-lead ECG
  • SaO2
  • Invasive/non-invasive BP
  • Central monitoring/observation
  • Infusion technology
  • Bedside O2

Phase I and Phase IIa Unit

  • Three independent clinical units
  • Mixed-gender capabilities
  • 96+ beds

Clinical Diagnostic Laboratory

  • Partnership with a large local central lab
  • High throughput capacity with rapid turnaround
  • Electronic transfer of lab results and on-site reporting

Investigator Experience

Specialty Board Certification

  • American Board of Internal Medicine
  • Internal Medicine / Medical Oncology

Active Medical Licensure

  • Pennsylvania (1974-present)
  • Maryland (1976-present)

Professional Positions & Appointments

  • Principal Investigator, BASi CRU (Bioanalytical Services, Inc.)
  • Executive Director, National Science Advisory Board for Bio-security, National Institutes of Health
  • Associate Chief Medical Director, Veterans Health Administration
  • Director, Office of Health Technology Assessment, U.S. Public Health Service
  • Director of Medicine Staff, Office of the Commissioner, Food and Drug Administration
  • Chief of Oncology, Kaiser-Permanente, northern Virginia
  • Medical Officer, Internal Medicine and Medical Oncology, U.S. Navy, National Naval Medical Center, Bethesda, MD and Naval Regional Medical
    Center, Portsmouth, VA

Staff Expertise

Experienced physicians, nurses, pharmacy personnnel, biostaticians, CRAs and research assistants

  • Dedicated project teams
  • 24-hour medical coverage
  • On-site data management group
  • Independent quality assurance unit

Patient Demographics

Extensive subject database of healthy males and females

  • Special populations include:
  • Obesity
  • Asthma
  • Diabetes
  • Hypertension
  • Renal and hepatic disorders

Other Information

Independent IRB for expeditious project start-up

  • Protocol development and review
  • Rapid turnaround, on-site meetings every 2 weeks
  • Post-submission regulatory follow-up

Contact Information

For more information, please contact:

Patrick R. Ayd
Executive Director
BASi Clinical Research Unit
302 West Fayette Street
Baltimore, MD 21201 USA
Phone: 410-385-4503
Fax: 410-385-1957
E-mail:

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    Last updated on February 19, 2008

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