Overview

Renstar Medical Research is located in beautiful north central Florida, one of the fastest growing retirement areas in the country. Renstar's research staff works with local physicians in private practice and community hospital settings to provide a multidisciplinary team focused on meeting enrollment goals while ensuring strict regulatory and protocol compliance. Renstar strives to be a valued resource to both the medical community and the pharmaceutical industry.

Renstar maintains the following full time dedicated in-house departments:

• Project management
• Quality control and remote data monitoring
• Recruitment
• Data management
• Regulatory
• Trial initiation
• Laboratory

Renstar offers the following benefits to sponsors and CROs:

• Commitment to high quality, regulatory compliance
• CITI GCP-trained, board-certified investigators
• CITI GPC, OSHA safety, ACLS, IATA training for clinical personnel
• Rapid study budget/contract negotiations and trial initiation
• Central IRBs for rapid regulatory submission turnaround
• In-house patient database with over 15,000 patient profiles
• Volunteers drawn from large local private practices
• Excellent community recruitment program
• Substantial experience with successful targeted advertising campaigns
• Active participation in community events, including providing disease-specific educational outreach programs

Research Experience

Renstar Medical Research has a proven reputation for providing high-quality clinical data and adhering to industry-established clinical research guidelines. Renstar is committed to meeting trial enrollment expectations and is consistently a top enrolling facility both nationally and internationally. Renstar has participated in more than 500 clinical research studies since its founding in 1998. Its multidisciplinary staff has more than 650 years of combined experience executing clinical research trials and has participated in phase 1 to 4 research in the following therapeutic areas:

• Acne
• Actinic keratosis
• Addiction
• Alzheimer's disease
• Atopic dermatitis
• Allergy
• Asthma
• Bioequivalence
• Biosimilars
• BPH
• Constipation
• COPD
• Dermatology
• Diabetes
• Diabetic neuropathy
• Devices
• Erectile dysfunction
• Female sexual dysfunction
• Fibromyalgia
• Healthy volunteers
• High cholesterol
• Hyperlipidemia
• Hypertension
• Insomnia
• Immunology
• Memory loss
• Men's health
• Migraine
• Mild cognitive impairment
• Neuroscience
• Nutraceuticals
• Obesity
• Osteoarthritis
• Osteoporosis
• Overactive bladder
• Pain management
• Postherpetic neuralgia
• Premature ejaculation
• Psoriasis
• Psychiatry/psychology
• Radiology
• Rheumatoid arthritis
• Sleep disorders
• Smoking cessation
• Ulcerative colitis
• Urology
• Vaccines
• Weight loss
• Women's health

Facility Description

Onsite

• Climate-controlled, secure drug-storage area
• Laboratories with centrifuge
• Phlebotomy area
• Remote data entry
• 24-hour ambulatory monitoring
• Temperature-monitored freezer/refrigerators (-20°C and -70°C)
• On-site, long-term storage
• Excimer laser
• IV infusions

• 10-bed, phase 1 unit with crash cart meeting ACLS criteria
• Patient Wi-Fi
• Electrocardiograms
• Blood pressure/temperature/pulse
• 24-hour visit facilities with TV and DVD
• Dedicated space for monitor visits with high-speed internet
• Scale
• Stadiometer
• Serial PK draws

Offsite

• Echocardiogram
• Bone Mineral Density
• Endoscopy
• Ultrasound
• Inpatient facilities (two hospitals
  within two miles of facility)
• X-Ray
• PET

• MRI
• Colonoscopy
• Treadmill stress tests
• Pulmonary function testing
• Urinary flow and prostrate ultrasound
• Catheterization laboratory
• Interventional radiology services

Investigator Experience

Affiliated Investigators

Allergy/Asthma
Thomas Johnson, MD
G. Edward Stewart, MD

Dermatology
Frederick Behringer, MD
Ashley Cauthen, MD

Dietary Counseling
Joy Semelka, MS, RD, LD, CDE

Endocrinology & Metabolism
Sidney E. Clevinger, MD

General/Internal Medicine
Sidney E. Clevinger, MD
Frank Fusco, MD
John Nardandrea, MD
David Oliver, DO
Mark Patterson, MD

Neurology
Anette Nieves, MD
Katherine Standley, DO

Opthamology
Seaborn Hunt, ⅠⅠⅠ, MD

Urology
Charles T. King, MD, FACS

Psychiatry/Psychology
Timothy Byrd, MD

Pulmonary Medicine
Raj Karunakara, MD

Staff Expertise

Managerial
Joseph Sorrentino, RPh MAcc
President, Clinical Pharmacist

Mary C. Brantley, BSN, RN, CCRC
Vice-President of Clinical Operations

Aaron Campo, BS
Chief Operating Officer

Permanent, full-time staff include registered nurses, licensed practical nurses, a paramedic, a registered respiratory therapist, a registered radiology technologist, regulatory specialists, clinical research assistants, data specialists, recruitment specialists, quality control specialists and pharmacists, with a combined total of 350 years of clinical research experience.

All clinical staff hold ACLS certification for patient safety. In addition, most of our study coordinators are either ACRP- or SOCRA-certified.

Other Information

Renstar Medical Research understands that the clinical research industry is constantly changing. Renstar is committed to remaining knowledgeable by utilizing resources from DIA, ACRP, SCRS and other appropriate sources to facilitate the continued education of its staff. Renstar is dedicated to providing superior patient care, accurate data collection, rapid reporting and open communication with its sponsors and investigators.