The Neuroscience Research & Clinical Trial unit at Hawaii Pacific Neuroscience is one of the most sought after clinical trial site in the US for neuroscience conditions because of its reputation for excellence in clinical care and operational excellence in research and clinical trials. Hawaii Pacific Neuroscience is the leading and one of the largest provider of neuroscience care in Hawaii and the practice is growing with over 2500 NEW patients every year. The clinical trial site has a reputation for patient recruitment and retention, standardized streamlined electronic database with close to 10,000 patients in the practice, standardized prescreen procedures. The facility encompasses over 7,000 square feet of office space with 24 exam rooms including dedicated clinical trial facility and exam room including in-house centrifuge, subzero refrigerator, one temperature controlled, locked drug storage room and file storage (short term and long term storage), reception area, private waiting room, large parking area and adequate work space for site and monitor visits. Facility is in same building with overnight medical and nursing care for overnight patients and less than 0.5 mile from emergency room. Facilities are fully handicap accessible and offers cable TV, available Wi-Fi, DVD and book library, ensuring the comfort of patients. Facility is open Monday -Saturday, 8:00am-5:00pm. All subjects can call facilities main number after-hours in case of emergency and will be contacted by an On-Call Physician, otherwise subjects are instructed to dial ‘911’ if an event is life-threatening. Site is available to receive, store and acknowledge study drug in IWRS Monday-Friday. If the designated staff member is not available there is always back-up staff available to receive, store and acknowledge study drug in IWRS Monday-Friday. IP is stored on shelves in a separate room in the office behind a single locked door requiring hard key access. The IP storage room is temperature controlled 7 days/week Monday-Sunday with a min/max digital thermometer. The temperature is manually recorded daily on a paper log five days a week. There is an alarm for temperature excursions. The site IP dispensing practice is to follow protocol procedures regarding IP dispensing. The min/max digital thermometer is calibrated yearly, January 2016 will be the next calibration date. The site has the following equipment: Manual Blood Pressure Cuffs, Digital Weight Scale, -20 Freezer, Ambient Centrifuge, 12 Lead ECG machine.
The equipment listed above is calibrated manually; documented with a sticker on the equipment and documented in a log on site. The site has availability of dry ice daily or weekly and laboratory personnel are IATA certified. Site staff Coordinators have experience with several EDC systems and iMedidata. Site coordinators can comply with eCRF completion guidelines and respond to EDC queries in a timely manner. Site staff has experience with several IWRS systems including BioClinica. The site prefers a wired LAN transmission of ECG and Spirometry data.
Principal Investigators: Kore Liow, MD is a board certified neurologist with over 15 years clinical research experience. In the past 15 years, has served as PI or site PI for over 40 clinical trials in neuroscience including Epilepsy, Dementia, Parkinson’s Disease, stroke studies among others sponsored by the industries, NIH, CDC and others. Dr. Liow has over 20 years’ experience with completion of various rating scales for neurologic disorders in clinical trials. He dedicates over 50% of his time in clinical research. Dr. Liow received his Neurology training at University of Utah and completed a fellowship in Epilepsy Research Branch, NINDS, NIH.
Sub-Investigators (SubI): Panida Piboolnurak, MD is a board certified neurologist with over 10 years of clinical research experience. She has served as an investigator for neuroscience clinical trials including Parkinson’s disease, dementia and others. She completed neurology training at Cornell University and fellowship in Parkinson’s and Movement Disorders at Columbia University in New York and is specially trained in Parkinson’s related ratings like UPDSR and PD Diary for over 10 years. David Kaminskas, MD is a board certified neurologist with special interest in headache and stroke as well as general neurology. Irisa Devine, MD is a board certified pediatric neurologist trained at Mayo Clinic with fellowship training in pediatric epilepsy, neuromuscular diseases, pediatric EEG and EMG. Patricia Borman, MD is a board certified family medicine physician and geriatrician skilled in basic medical exam, EKGs. Tiffany Sandoval, PhD, Licensed neuropsychologist skilled and experienced in ratings in clinical trials. Thomas Harding, PsyD, Licensed neuropsychologist skilled and experienced in ratings in clinical trials.
PI and SubIs are experienced investigators with average of more than 10 years of clinical trial experience in neuroscience.
The PI and SubIs are supported by a team of full time dedicated research staff. Team is managed by a full time dedicated Clinical Research Project Manager who has over 5 years of experience in clinical research and who has served as clinical research coordinator (CRC) for over 60 trials including 2 FDA audits who will oversee a team of CRCs including an APRN and an RN. All staff are cross-trained on all studies so there is no issue with time out of office. PI delegates responsibilities per study protocol and scope of staff. Coordinators usually oversee patient’s visits, with PI supervision and ultimate responsibility. PI is very involved in each visit, completes and reviews the consenting process for most visits. All physical exams completed by PI or Sub-I, delegation log describes in more detail per study. PI is 100% available to research facility, and always available at all CRA visits. PI undergone research fellowship training at NINDS, NIH and has extensive experience with FDA regulated studies and SubIs and staff involved with research has current certificates for ICH-GCP training. PI and Sub-Investigators will have no restrictions related to their professional practices if they participate in this study.