Clinical Pharmacology of Miami
Clinical Pharmacology of Miami (CPMI) was founded to serve a real need for a high quality clinical research unit. We have the experience and facility to conduct safe, precise, well controlled clinical research with new and existing drugs.
The dedication of the staff at CPMI led by Dr Lasseter, Vice President and Medical Director, Stacy Dilzer, President, and Cooper Shamblen, VP of Clinical Operations, is evident in the success of CPMI. Together they have a strong clinical resume with over 100+ years of research experience.
Dr. Lasseter has been Principal Investigator of approximately 1800 clinical studies (over past 40+ years) of the safety and efficacy and mechanisms of action of Phase I, II and III drugs as well as bioavailability and pharmacokinetic studies in normal subjects and in special populations. Numerous clinical studies have been successfully audited by sponsoring institution audit teams and by Food and Drug Administration Audit Teams. Virtually all studies have been conducted under auspices of active IND applications and approximately 60 successful NDA’s have contained data generated by these studies. These include:
RSVP (Research Subject Verification Program) is a web based central database used to track the dosing dates of Phase 1 research subjects to prevent them from participating in multiple research trials simultaneously and from by-passing required protocol wash-out periods. Recently, Clinical Pharmacology of Miami, along with other Phase 1 research sites in South Florida, agreed to report the dose taken date(s) of subjects participating in Phase 1 drug studies to RSVP. By reporting these dates, sites on RSVP can access the subject registry at the time of screening to help determine the last time a potential participant received dosing of investigational medication. The subjects are identified by digitizing their fingerprint which generates a unique 9 digit number. The result of implementing RSVP, is that cleaner subject populations are selected for studies. Sponsors that contract sites using RSVP know their data comes by way of subjects that undergo thorough screening measures to eliminate participation in more than one study simultaneously or before an appropriate washout.
acrovastine, alendronate, amiloride, amrinone, arbutamine, atenolol, benzazepril, candesartan cilexetil, carteolol, caspofungin, ciprofloxacin, dofetilide, enalapril, encainide, eplerenone, recombinant erythropoietin, etodolac, famotidine, felodipine, finasteride, flecanide, fosinopril, galantamine, grepafloxacin, indapamide, irbesartan, leucovorin, lisinopril, losartan, meropenem, milrinone, moexepril, montelukast, nefazodone, nimodipine, nisoldipine, nitroprusside, nizatidine, oxaprozin, penbutalol, pinacidil, piperacillin, piroxicam, prazosin, ramipril, 13-cis retinoic acid, rofecoxib, sinemet CR, sirolimus, sitagliptin, sulindac, tegaserod, timolol, terazocin, tocanide, trandolapril, valsartan, venlafaxin, zafirlukast, zolmitriptan and zolpidem.
The CPMI Research Unit and location was carefully considered. Our facility was meticulously custom designed and constructed, employing all the knowledge of our experience. We are convinced that our 120 bed research unit is “State of the Art”. We are equipped with the experience, expertise and the research unit facility to meet the individual needs of each sponsor and research protocol.
The 24,000 square foot facility is not a hospital, it is not a hotel, it is not an ICU, but it is a custom designed Clinical Pharmacology Research Unit.
CPMI uses a validated environmental monitoring system to ensure the quality and integrity of all pharmacy room temperatures, refrigerated / frozen drugs and samples stored within the CPMI research facility.
Security Cameras are stratigically placed throughout the CPMI research facility, both inside and outside, to monitor and record all activity 24 hours a day, 7 days a week. Entry and Exit doors, including fire exits, are alarmed with audible sirens at all times to secure controlled access to and from CPMI.
Separation between volunteer inpatient and outpatient areas are strictly secured with locked doors accessible only by staff members with swipe-cards / push-button security codes.
Clinical Pharmacology of Miami is protected by a stand-by 40k watt natural gas generator. In the event of loss of Florida Power & Light power to the building, the strong, but quiet generator automatically detects the loss and starts providing power to all essential portions of the facility.
This includes: all the refrigerators, freezers, centrifuges, and security monitoring equipment. The natural gas supply allows the generator to work without interruption for an extended period of time.
- Screening Department / Interview / Exam Rooms / Prescreening lab & more
- Out-patient department
- Secure and monitored PK sample processing laboratory
- Secure temperature alarm monitored -20 and -70C freezers
- Secure alarm monitored pharmacy department
- Secure and monitored CRF / Record rooms
- Secure Entryways
- Standby Generator
- 120 clinical research beds
- 3 large PK bedded rooms
- 6 private research rooms (2 plus beds each)
- 2 very spacious recreational areas for volunteers
- Supervised Internet access areas for subjects
- Entire facility monitored by clinical staff, onsite 24 hours a day 7 days a week
- Security Video Monitor Recording 24 hours a day, 7 days a week
- Executive suites
- Conference rooms
- Record review rooms with monitors’ work areas
- Study coordinator / offices
- Women’s health examination areas and ultrasound equipment
- Data entry / regulatory affairs department
- Entire facility handicap accessible
- Spacious private parking
- QTc Clinical trial ECG monitored research areas equipped with individual telemetry units
Kenneth C. Lasseter, M.D
Kenneth C. Lasseter, M.D., is the Vice President and Medical Director of Clinical Pharmacology of Miami, LLC. Dr. Lasseter is a clinical pharmacologist certified by the American Board of Clinical Pharmacology, and is board eligible in Cardiology and Internal Medicine. Over the past 38 years, he has served as Principal Investigator on over 1,800 clinical trials and has contributed to approximately 60 successful NDAs. Dr. Lasseter has published over 300 articles and abstracts in the area of clinical pharmacology, and continues to be active in studies pertaining to development of safe and effective new drugs. Dr. Lasseter truly has a national and international reputation as an outstanding clinical pharmacologist and Principal Investigator.
Dr. Lasseter began his research career while at the University of Miami, School of Medicine. He has served as an Assistant and Associate Professor of Pharmacology and Medicine at the University of Miami, School of Medicine, and as an Adjunct Professor of Pharmacology at the University of Miami Miller School of Medicine. He is a frequent lecturer for post-graduate courses and medical programs. Dr. Lasseter earned his doctorate degree from the University College of Medicine in Gainesville, Florida. He completed his residency at University of Kentucky in Lexington, Kentucky and a postdoctoral fellowship in Clinical Pharmacology and Cardiology at the University of Miami School of Medicine, Miami, Florida.
Juan Carlos Rondon, MD, JD, CPI, FCLM
Dr. Rondon is a Principal Investigator and Sub Investigator at Clinical Pharmacology of Miami. He has experience in over 70 Clinical Trials. Dr. Rondon is a certiﬁed clinical investigator with extensive certiﬁcations in clinical research practices and code of federal regulations. Dr. Rondon was a lead investigator and principal investigator prior to serving at CPMI. He holds degrees from Nova Southeastern University and was a resident at Temple University.