Our Mission
InSite Clinical Research is dedicated to improving the mental health and quality of life for all humankind by contributing to the advancement of scientific knowledge by conducting high quality clinical research leading to the future treatments and cures of tomorrow.
Clinical Research Experience
Successfully completed clinical trials in the following CNS indications:
ADHD
(Children, Adolescents, and Adults)
Alzheimer’s Disease
(Early MCI, Moderate, and Severe)
Autism
Bipolar Disorder
Chemical Dependency
(Opioid, Alcohol, and Cocaine)
Chronic Pain
Generalized Anxiety Disorder
Major Depressive Disorder
Obsessive Compulsive Disorder
(OCD)
Schizophrenia
Schizoaffective
Tardive Dyskinesia
Successfully completed clinical trials in the following Medical indications:
Diabetes
Fibromyalgia
Hyperlipidemia
Insomnia
Migraines
Osteoarthritis
Smoking Cessation
(Adolescents and Adults)
Successfully completed clinical trials in the following arenas:
Bioequivalence Studies
Cognition Studies
Dose Rating
Drug Interaction Studies
First in Human Studies
Infusion Studies
Pharmacokinetics Studies
Phase 1 Studies
Proof of Concept Subjects
(single and multiple doses)
Safety and Efficacy
Placebo separation achieved in numerous completed clinical trials.
Successful completion of numerous clinical trials resulting in the final approval of the investigational product.
Investigator Background
Dr. Shiwach was trained in Psychiatry in the U.K. and at The University of Texas Southwestern Medical center in Dallas, TX, where he later served as a member of the faculty. As Medical Director of research at Terrell State Hospital in Terrell, Texas, Dr. Shiwach managed the research facility for five years while serving on the faculty of UT Southwestern Medical Center. Dr. Shiwach has published over 40 peer‑reviewed papers in various scientific journals and is Board certified in Adult Psychiatry. While at Terrell State Hospital, Dr. Shiwach served as the Principal Investigator for multiple sponsored clinical drug trials in Schizophrenia, Bipolar Disorder and Depression, Phase II through Phase IV.
Dr. Shiwach began his private practice in 2004 and currently heads InSite Clinical Research, a successful research site in DeSoto, Texas located south of Dallas and part of the greater Dallas/Fort-Worth Metroplex. Dr. Shiwach currently serves as the Medical Director at Hickory Trial Hospital in Desoto, TX, overseeing an adult inpatient psychiatric hospital and a day hospital program. He is currently conducting multiple studies in CNS/Psychiatric Disorders.
Access to local Mental Health Hospitals including Hickory Trail Hospital and Dallas Behavioral Health
Access to local outside vendors, e.g. MRI, PET and CAT scans, lumbar puncture, etc.
Access to Internal Medicine and other Specialty doctors for consults as needed
Overnight Clinical Research Unit
The Overnight Clinical Research Unit titled Serenity is our privately owned building located in a Medical Plaza surrounded by multi-specialty medical clinics south of the Dallas Metroplex. The facility is located in close proximity to Charlton Methodist Hospital and public transportation is easily accessible.
UNIT FEATURES:
- The Unit has 12 beds, with the flexibility to add additional beds as needed (up to 24).
- The Unit has two fully equipped PSG sleep labs that are Clinilabs Certified.
- Each room has its own handicapped accessible restroom and shower. All rooms are fully equipped with Cable TV and DVD capabilities.
- There is a large dayroom that includes: a 60” Television, Video game consoles, two computers, leather sofas and dining areas, and multiple other forms of entertainment. The dayroom is annexed by a large patio where patients can eat meals outside and enjoy other outside activities.
- All fire and OSHA regulations are current and up to date.
- Transportation is provided to patients as needed.
Trial Medication
- Double-locked medication storage room.
- Refrigerated storage.
- Temperature logs kept for all IP.
Institutional Review Board
- InSite Clinical Research uses a Central IRB for all clinical trials.
- Applications/submissions are completed either via on-line portal, e-mail, fax and/or courier.
Equipment
Physical exam room fully equipped
Centrifuges – refrigerated and ambient.
-20° C freezer with temperature monitor.
-70° C freezer with temperature monitor.
Digital synchronized clocks
Manual scales, digital scales, and electronic blood pressure machines.
Telephone, fax, and Wi-Fi capabilities throughout the building.
CCTV in all areas of facility, monitored by staff.
Backup generator.
Defibrillator
Study Participant Recruitment & Advertising
- Unless provided by the Sponsor, advertisements for study participants are created by our recruitment department in our Main Research Office and are approved by the Central IRB and Sponsor.
- InSite Clinical Research maintains a study participant database.
- InSite Clinical Research has a four-member recruitment team that relies on:
- Private Practice (Raj. Shiwach, MDPA), outpatient clinic.
- Advertisements: Social Media, TV, Radio, Print, and Flyers.
- Inpatient and Outpatient Hospital Referrals. Our staff has access to local Mental Health Hospitals in the local area with over a 200+ bed census.
- Boarding and Group Homes. Our staff has access to over 60+ homes in the surrounding areas.
- Community Outreach – Community events, Lunch and Learn programs, and NAMI events.
- Current Company Website: www.insiteclinical.com
Quality Assurance
Our Quality Assurance (QA) manager facilitates adherence to ICH/GCP/FDA guidelines and InSite Clinical Research SOPs.
Meetings are held on a regular basis to review ongoing activities and to discuss topics that include: Ongoing training and continued education, study enrollment, recruitment, and protocol amendments.
Main Research Office
941 York Dr., Suite 205, DeSoto, TX 75115
Phone: 972-283-6286
Fax: 972-331-8748
Overnight Facility
1008 York Dr., DeSoto, TX 75115
Phone: 214-420-1484
Fax: 214-420-9453
