Research Center Profile:
Nutrition and Weight Loss
MD Clinical is a private, PI owned and operated clinical trials site conveniently located in a Luxury A, medical building in Hallandale Beach, FL that provides inpatient Phase 1 and outpatient Phase 2-4 care. This location serves the Miami-Dade and Broward counties in South Florida. We specialize in trials of new medications or new usage indications in internal medicine, neurological, or psychiatric disorders. The principal investigators Drs. Wilks and Safirstein are on-site full-time supervising all clinical research trials at the center. They have successfully conducted over 400+ clinical research trials. The site is especially renowned for its extensive experience and expeditious recruitment in trials for Phase 1 Healthy Subjects, Phase 1 Specialty Populations, Primary Insomnia, Restless Leg Syndrome, dementia, Alzheimer's disease, Migraine, Major Depressive Disorder, Anxiety, Attention Deficit Disorder, Post Herpetic Neuralgia, Painful Neuropathy, Arthritis, Hypertension, Obesity, Smoking Cessation, and Diabetes Mellitus. Our center has an extensive database with over 7,000 patients. The office has a complete, professional, full time certified study staff. Our center is independent and utilizes central IRB’s. Contracts, Budgets, and Regulatory Packets are turned around in 72 hours for an expeditious start up.
Number of Studies Conducted: 400
Number of Studies Actually Completed: 390
Number of Active Patients in the Database: 7000
Regulatory Submission Turn-Around Time: 1 Week(s)
Average Number of Total Patients Enrolled: 500
Average Percent of Total Patients Randomized: 80%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 95%
EDC Capabilities: Yes
Our Center is experienced with conducting studies in Healthy Phase 1, Disease Specific Phase 1, Alzheimer's Disease, Mild Cognitive Impairment, Primary Insomnia, Restless Leg Syndrome, Sleep Apnea, Depression, Anxiety, ADHD, ADD, Migraine Headaches, Diabetes Mellitus, Hypertension, Renal Impairment, Osteoarthritis, painful Peripheral Neuropathy, and other neurological and psychiatric conditions. Co-Presidents Drs. Wilks and Safirstein guide the operation with over 30 collective years of experience in conducting clinical trials. Both have successfully conducted over 400+ clinical trials ranging from Phase 1-4 and multi-indications. Clinical research support CRCC’s have 2-15 years of research experience.
Our Phase 1 capabilities include PK/PD studies, Proof of concept studies, Bioequivalence/ Bioavailability studies, Dose-Response, Dose-Escalation, Food Effect, Genotyping, Drug interaction studies, Drug metabolism, Safety & Efficacy, & Cardiac Safety & QTc.
Our Phase II-IV includes any of the above Phase 1 capabilities when required and psychometric capabilities for the proof of concept and efficacy portion required in CNS clinical trials. We are able to conduct various internal medicine indications and have specialty training in CNS to conduct psychological testing for all indications (Alzheimer’s Disease, Depression, Anxiety, & Sleep disorder), computer battery, and driving simulator programs. We have participated in actigraphy sleep studies, hormones stimulating ACTH, IV infusion, vaccine, and dim light requiring programs.
Our site utilizes Central IRB’s and Laboratories. We can also utilize our local laboratory for stat blood results.
Our center is a Luxury A, smart facility with state of the art technology. We are located in the heart of Hallandale Beach. It is easily access by major highways in the area and located within miles from Fort Lauderdale or Miami Airport. Our facility is locked down with only security access to areas within.
- 9,500 sq foot private facility
- Patient reception area
- 6 outpatient interview rooms for history taking and informed consent
- 3 Laboratory rooms for vitals, blood draws, ECG’s, and lab kit storage. Our patient exam tables are ADA compliant for the elderly and disabled. Our laboratory has refrigerators, freezers, both -20 and -70 that are monitored daily with temperature log collection. We further have a refrigerated centrifuge for PK samples, ECG machines, holter monitor capabilities, and telemetry capabilities. Lab processing area with CLIA waiver. We further have a crash cart and an AED on site with ACLS trained staff. All staff Hazmat-certified.
- Clean procedure rooms for LP’s and other procedures
- Nursing station
- 41 inpatient bed unit has 24 hour monitoring, full bathroom, patient day room, dining room, and food service.
- 8 private sleep laboratory rooms with Grass Polysymnography that converts to EDF format
- Secure electronic access to our drug room/pharmacy. It is climate controlled, monitored with daily temperature and humidity logs, and has double lock capabilities for both refrigerated and shelf drug.
- Private, locked study coordinating offices for source document, CRF, and regulatory binder retention.
- 8 comfortable, dedicated monitor rooms equipped with t lines, phone lines, and photocopy machines.
- 8 quite rooms for Psychometric/Psychological testing
- Executive Suites
- Spacious private parking
- Facility is handicap accessible
- Secure on site record storage
- Security monitoring command center
The Principal Investigators at MD Clinical are Drs. Wilks & Safirstein. Both Doctors are trained in GCP (Good Clinical Practices) and ICH guidelines. Both have participated in multiple pivotal multicenter as well as proof of concept clinical trials. Dr. Kerri Wilks and Dr. Beth Safirstein are board certified by the American Board of Psychiatry and Neurology. Both have been further trained and certified by outside agencies. Dr. Wilks is a Certified Principal Investigator (CPI) from the ACRP (Association of Clinical Research Professionals), and Dr. Safirstein is a certified clinical trial investigator from the University of Rochester School of Medicine and Dentistry and WIRB.
Our clinic has a full complement of CCRC certified study coordinators, master's level/PhD psychologist/raters, lab technicians, data managers, and support personnel. Our clinic follows strict HIPPA and PHI policies to protect the privacy of our study patients. We uphold strict safety policies for their added security.
MD Clinical serves the South Florida area. We are conveniently located on Hallandale Beach Blvd. in Hallandale Beach, Florida. This location serves the Miami-Dade and Broward Counties in South Florida. Our subject population is adolescent, adult, and elderly males and females. We have healthy normal’s and disease specific populations as listed in our clinical research experience section. Our database includes over 7,000 patients. Our bi-lingual staff proudly serves a large Hispanic population.
Please call our center at 954-455-5757 and speak to our patient recruiter for a comprehensive list. This is only a small sample of current enrolling trials.
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
the research center will then follow up with you.