Research Center Profile:
SHANTI Clinical Trials
Neurology
Pharmacology/Toxicology
Psychiatry/Psychology
This is a day and night private practice of a group of psychiatrists California Board Certified with a diversified pool of 8000+ mentally ill patients. Established in 1992 this probably is one of the busiest out-patient psychiatric practice in the County of San Bernardino, CA. Presently there are a multitude of physicians in the group.
Satish M. Sood, PhD. (Director Clinical Research): Primary contact person for the studies and supervising all clinical trials at the site.
Harbans Multani, M.D. (California Board Certified): Principal Investigator in ADHD study Depression study and two studies of schizophrenia and Bipolar I disorder.
Faisal Qazi, D.O. (California Board Certified): Neurologist: Director Headache and Cerebrovascular Disease Program, Member Board of Directors Autism Support and Advocacy Group, Epilepsy Center-Patient Advocacy and support Foundation Group. Principal Investigator for Stroke study.
Salvador E. Lasala, MD Child, Adolescent and Adult psychiatry (Principal Investigator)
Warris Richard Walayat, M.D. Child, Adolescent and Adult Psychiatrist, Sub-Principal Investigator in two studies of schizophrenia and depression study.
We actively performed research and clinical trials for more than eight (8) years. The Director Clinical Research, Satish M. Sood Ph.D. has 33+ years of research experience thus enhancing our credentials.
Our current/latest involvements in the past about 3 years are:
| Adult Studies | Child & Adolescent Studies |
|---|
| |
| 1) Total Adult Depression Studies = 4 | 1) Depression for Children = 1 |
| 2) Total Adult Schizophrenia = 5 | 2) ADHD for Children = 3 |
| 3) Total Adult ADHD = 1 | 3) Bi-Polar for Children = 1 |
| 4) Total Adult Migraine = 1 | |
| 5) Total Adult Stroke = 1 | |
| 6) Total Adult Opioid Dependency = 1 | |
We have 4 active studies now. We are also collaborating/have collaborated in the past with NIH, NIMH, National Institute of Neurological Disorders and Stroke (NINDS), Yale University, University of North Carolina & Duke University on different clinical trials.
Our site has been approved by most of the major pharmaceutical industries.
Our research center has worked with Mc Neil, Eli Lilly, Point, CNS Response, Somerset and Brain Resources.
Since 1988, Dr. Sood was on the Faculty School of Medicine, Loma Linda University, Loma Linda, CA 92325, actively involved in research, have numerous publications in journals of repute and have a total research experience of 33+ years and joined this psychiatry group about 5 years ago as Director Research.
The Facility covers 6,000 sq. ft. area with ample parking space, a comfortable waiting room, patient check-up rooms, and secure storage procedures for investigational chemical entities, and documents.
On the ground floor we have our office, two private screening rooms, an EEG lab, a lab for the phlebotomist and enough storage and working space for the staff. A large reception room, for greeting prospective subjects as well as subjects already in current trials. Screening rooms are used for all study procedures to ensure that subject information is kept confidential. Our lab technician is well trained and certified. In the lab we have centrifuge, facilities of doing EKG’s, and for r-EEG, blood draws as well as certain sample preparation arrangements. We have four telephone lines so no waiting for incoming subject phone calls.
There is a locked room for medications, and specimen freezers. We have both a -10 degree and -20 degree freezers. All medications are kept in locked cupboards, under double lock where only authorized personnel have access. A temperature log is properly maintained on daily bases. In this room there is a back up arrangement for any power failures. We have two fire proof cabinets also for study drug storage.
We also have a specific room with high speed internet access, for monitoring visits. Each staff member has its own personal computer with a DSL connection, protected by password. All staff maintains high standards of privacy and confidentiality.
This technologically adept institution positions itself toward future research opportunities complete with ECRF capabilities, experience with IVRS systems and consistent blinding processes. We have centrifuges, -20 degree freezers, EKG machines EEG machines and access to MRI, other metric equipment, on site clinical laboratory and much more.
The site affiliates with a dynamic, on site fitness facility complete with a dedicated expert trainer.
FDA inspection held on December 15, 2010 to January 7, 2011 and got the clearance report that we adhered to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.
All the physicians and the research staff have certification for GCP & Human Subject Protection Training.
The study coordinators are experienced and have medical background. Each study has a back up study coordinator. The data management personal is highly qualified.
We have a diversified pool of 8000+ mentally ill patients with approximate demographics,
- Schizophrenia: 1500
- Attention Deficit/ Hyperactivity Disorder: 2000
- Major Depression Episode: 2000
- Bipolar Disorder 1000
- Epilepsy 500
- Mixed: 1000
- Male: 55% Female: 45%
We use central IRB.
We out source Clinical trials to INDIA. We have 2 offices in India with highly qualified & dedicated staff, very strong network of Physicians and Hospitals.
Additional Email Address:
s.sood@hotmail.com
If you are interested in contacting this center to discuss placing a clinical
trial there, please complete and send the email form below. A representative from
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