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(305) 420-5636
For Industry Sponsors & CROs

Your Phase I–IV Research Partner in South Florida

A dedicated clinical research facility led by Edward Mezerhane, MD, FAASM, FACP, DABOM, CPI — conducting pharmaceutical and medical device trials with a DEA Schedule I–V researcher license and a built-in patient referral pipeline.

0+
Trials Led by PI
0+
Clinical Patients / Year
I–V
DEA Researcher License
Phase I–IV
Trials Conducted
Sponsors & CROs

Trusted by Industry Leaders

PharmaDev has conducted pharmaceutical and medical-device studies for leading global sponsors and emerging biotech across sleep medicine, obesity, and metabolic disease.

  • Eli Lilly
  • Novo Nordisk
  • Takeda
  • Alkermes
  • Harmony Biosciences
  • Bayer
  • Axsome Therapeutics
  • LivaNova
  • Nyxoah
  • Centessa Pharmaceuticals
  • Apnimed
  • Mineralys Therapeutics

Logos and trademarks are the property of their respective owners and reflect studies conducted at PharmaDev. Shown for identification purposes only and does not imply endorsement.

Principal Investigator

Edward Mezerhane, MD, FAASM, FACP, DABOM, CPI

Involved in clinical research since 2017 and PI on 45+ clinical trials. He maintains an active Sleep Medicine practice of 13 years that sees over 10,000 patients per year — a continuous, pre-qualified source of study participants.

ABIM Board Certified — Internal Medicine

Board certified in Internal Medicine by the American Board of Internal Medicine (ABIM).

ABIM Board Certified — Sleep Medicine

13 years of clinical Sleep Medicine practice; expertise in OSA, CSA, narcolepsy, idiopathic hypersomnia, insomnia, and circadian rhythm disorders.

ABOM Board Certified — Obesity Medicine

Diplomate of the American Board of Obesity Medicine (ABOM), extending capability into metabolic and weight-management trials.

Certified Principal Investigator (CPI)

CPI designation demonstrating mastery of GCP, ICH guidelines, FDA regulations, and trial oversight.

Competitive Advantage

Why PharmaDev vs. Generic Research Sites

Direct Patient Access
Affiliated practice (Sleep Medicine Specialists of South Florida) sees 10,000+ patients/year — a continuous, pre-qualified patient stream with no third-party recruitment.
Affiliated Specialist Network
Five-physician multi-specialty referral network spanning Pulmonary, Neurology/Psychiatry, ENT, Sleep Surgery, and Cardiology.
DEA Schedule I–V License
Researcher license enabling controlled-substance studies that most community sites cannot support.
Miami Market
Diverse Miami-Dade population enables enrollment of underrepresented and Hispanic demographics.
Site Capabilities

Full-Service Research Infrastructure

Designed to meet sponsor and regulatory requirements from site initiation through closeout.

Regulatory & Compliance

  • IRB-approved study infrastructure
  • FDA 21 CFR Part 11 compliant
  • GCP-trained research staff
  • Protocol deviation tracking
  • Audit-ready documentation

Patient Recruitment

  • Built-in practice referrals (10,000+ pts/yr)
  • Five-physician affiliated specialist network
  • Bilingual staff (English/Spanish)
  • Community outreach programs
  • Digital screening tools

Data & Operations

  • EDC system proficiency
  • Real-time enrollment reporting
  • Source document verification
  • SAE/AE reporting protocols
  • Lab & diagnostics coordination

Trial Types Supported

  • Phase I–IV clinical trials
  • Device studies
  • Observational studies
  • Registry studies
  • Compassionate use programs

Turnaround

  • < 30-day site activation
  • Rapid protocol feasibility review
  • Same-week patient pre-screening
  • Monthly sponsor reporting
  • 24/7 PI availability for SAEs

Therapeutic Focus

  • Sleep disorders (OSA, narcolepsy, IH)
  • Obesity & metabolic disease
  • Hypertension & cardiovascular risk
  • Type 2 diabetes
  • Chronic disease management
Facility & Equipment

Purpose-Built for Clinical Research

Dedicated monitoring, laboratory, and pharmacy space — plus access to an AASM-accredited sleep laboratory. All equipment is calibrated yearly, with cloud-based temperature monitoring and automated excursion alerts.

2 examination rooms

Conference room

CRA / CRO monitoring area

CRC work area

Laboratory area

Pharmacy — room-temp & refrigerated (DEA I–V)

8-bed sleep lab (AASM accredited) across 2 facilities

Battery back-up on all critical equipment

−80°C Ultra-Low Freezer

Long-term biological sample storage.

−20°C Freezer

Frozen sample and reagent storage.

2–8°C IP Refrigerator

Vaccine / investigational product cold storage.

Refrigerated & RT Centrifuges

4°C refrigerated centrifuge plus room-temperature centrifuge.

PFT / Spirometry

Pulmonary function and spirometry testing on site.

Sleep Lab (Seizure-Capable Montage)

8 beds total; 2 fully dedicated to clinical research.

12-Lead EKG

Electrocardiography for cardiac safety assessments.

IV Infusion Suite

Two IV infusion pumps with dedicated infusion chair.

Cloud-Based Temp Monitoring

Automated excursion alerting across all temperature-controlled units.

Research Personnel

An Experienced, Dedicated Team

From a CPI-certified PI to fully research-dedicated coordinators and regulatory staff.

Edward Mezerhane, MD, FAASM, FACP, DABOM, CPI

Principal Investigator

Triple board certified in Internal Medicine, Sleep Medicine & Obesity Medicine. Researcher since 2017; PI on 45+ trials. 13-year Sleep Medicine practice.

Patricia Sanchez, PA

Sub-Investigator

Fully dedicated research Sub-I supporting protocol execution, assessments, and participant safety.

Olivia Falcon, CCRC

Site Supervisor / Regulatory Specialist

Certified Clinical Research Coordinator. In research since 2012, coordinating over 100 clinical trials.

3 FTEs
Clinical Research Coordinators
1 FTE
Research Nurse
Affiliated Multi-Specialty Network

A Five-Physician Referral Network

Affiliated specialists extend our reach across therapeutic areas — supporting recruitment, co-management, and protocol-specific referrals.

Veronica Palmero, MD

Pulmonary Medicine

Associate, Sleep Medicine Specialists of South Florida

Idriz Kovacevic, MD

Sleep Medicine, Psychiatry, Neurology & Addiction Medicine

Associate, Sleep Medicine Specialists of South Florida

Julio Barcena, MD

Cardiology & Heart Failure

Partner, Top Cardiology Miami

Felipe Martinez, MD

ENT & Allergy

Partner, South Florida ENT Associates

Rolando Molina, MD

ENT & Sleep Surgery

Partner, South Florida ENT Associates

Start the Conversation

Submit an RFP or Site Inquiry

Discuss protocol feasibility, site qualification, or request a site file. We typically respond within 1 business day.

Or contact us directly: (305) 420-5636 · Fax: (305) 420-5540 · info@pharmadevresearch.com

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