Research Personnel

Experience

PCCAB has been involved in research since 2005, and established a dedicated research department in 2008. Since 2008 we have conducted over 80 trials as part of NIH consortiums, (NHLBI, and NIA), and from over 30 different pharmaceutical and device companies.

PCCAB is unique in that it can offer trials and recruitment at multiple sites. Principal investigators are situated at multiple locations allowing us to determine the most appropriate central location for each trial. By referring patients to trials within our own practice we ensure maximal recruitment and patient satisfaction.

Because of our large patient pool we typically recruit patients from our own practice. This has led to a detailed prescreening process, leading to few screenfails and maximum enrollment.  Since 2008 we have maintained patients in our studies of up to 5 years at a rate of over ninety-five percent.

Research Team

• Research Director: David Highfield, Ph.D. Dr. Highfield has over 30 years of experience in everything from in vitro lab work to human subjects research, including teaching research methods at local universities.
• Lead coordinator: Diane Nguyen has experience in human clinical trials
• Multiple MDs are experienced in research as well and serve as the PI on all medical studies
  • Dr. Alan Schwartz: Sleep medicine
  • Dr. Mitchell Schwartz: Pulmonary Medicine
  • Dr. Brian Bohner: Sleep and Pulmonary medicine
  • Dr. Linda Barr: Pulmonary medicine
• Medical Assistants experienced in drawing blood for labs
• Several nurse practitioners.

Training:

• All personnel are trained in GCP and ethics. Retraining occurs every two years, and sometimes more often depending on the needs of the sponsor.
• All coordinators have IATA training every two years.
• Experience using a wide variety of EDC systems.

Services:

As a stand-alone physician practice we are able to prepare and submit contracts and IRB protocols within weeks rather than the months it takes to go through larger universities and hospitals.

• writing IRB protocols for smaller startup companies
• IRB preparation for large pharmaceutical companies
• regulatory preparation
• Informed consent form writing
• budget preparation
• contract negotiation

Equipment:

Equipment on site is calibrated yearly

• Centrifuge
• Refrigerated centrifuge
• Dedicated research refrigerator
• -20 freezer
• -70 freezer
• Scales
• BP monitors
• SpO2 monitors
• EKG machine.
• Handheld PFT machine,
• 3 PFT labs onsite ( plus experience using a wide variety of sponsor supplied PFT machines)
• Dedicated research exam room plus 15 other exam rooms
• Dedicated locking drug storage room with limited access.
• Dedicated sleep lab with 8 beds ( 4 at each location) using a Respironics Alice 6 system
• DME supplies

Contact information:

Diane Nguyen
Clinical Research Coordinator

515 Fairmount Ave Suite 500

Towson, MD 21286