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.
Study Focus
- Drug interaction
- Bioequivalence
- Dose escalation
- Bioavailability
- Safety and tolerance
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
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
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
Extensive subject database of healthy males and females
- Special populations include:
- Obesity
- Asthma
- Diabetes
- Hypertension
- Renal and hepatic disorders
Independent IRB for expeditious project start-up
- Protocol development and review
- Rapid turnaround, on-site meetings every 2 weeks
- Post-submission regulatory follow-up
If you are interested in contacting this center to discuss placing a clinical
trial there, please complete and send the E-mail form below. A representative from
the research center will then follow up with you.
