Clinical Research Specialists, LLC provides extensive service to our sponsors, physicians, CROs and research patients. We are committed to enrolling qualified patients, providing high-quality data and exceeding our enrollment goals.
Our team has a combined 40 years of clinical research experience in adult and pediatric studies.

Our clinical trial experience includes:

  • Allergy

  • Asthma

  • Bronchitis

  • Bronchiectasis

  • Cardiovascular Disease (CAD)

  • Chronic Obstructive Pulmonary Disease (COPD)

  • Gastrointestinal Disorders

  • Idiopathic Pulmonary Fibrosis

  • Mycobacterium avium Complex (MAC)

  • Lung Cancer Screening

  • Pulmonary Arterial Hypertension (PAH)

  • Osteoarthritis

  • Pain Management

  • Pulmonary Nodules

  • Rheumatology

We are currently partnered with a private practice, Florida Lung Asthma, and Sleep Specialists (FLASS), and we look forward to partnering with other private practice specialists in the near future. We screen and select our study patients using the FLASS database, as well as outside referrals and advertisements.

Additionally, we have three Advanced Registered Nurse Practitioners (ARNPs) on staff to assist in ensuring our volunteers receive exceptional, compassionate care. We also have two dedicated full-time Clinical Research Coordinators (CRCs), and one Assistant CRC.

Facility Description

Clinical Research Specialists, LLC is an outpatient facility. We are uniquely located one mile from Florida Hospital Celebration Health. Our site has the ability to accommodate small inpatient studies at our 2-bed facility.

Our specialized equipment includes (but is not limited to):

  • 4-bed sleep lab
  • On-site lab with IATA trained research personnel
  • -20 ºC freezer
  • -80 ºC freezer
  • 2-8  ºC Refrigeration (locked)
  • Study drug cabinets (locked)

Site Metrics

  • Number of Studies Conducted: 18

  • Number of Studies Fully Completed: 11

  • Number of Active Patients in Database: 44,000

  • Regulatory Submission Turn-Around Time: 14-28 Days

  • Average Number of Total Patients Enrolled: 7

  • Average Percent of Total Patients Randomized: 75%

  • Avg Percent of Completed Studies Met Enrollment Goals: 75%

Site FAQ

  • EDC Capabilities

  • X-Rays on-site

  • Sputum collection single sample or serial collection

  • Wi-Fi access

  • Pharmacokinetic experience

  • Serial Spirometry

  • CPET administration

  • CT Scan

  • 6-Minute walk designated area

  • Echo

  • Pulmonary function test

Completed  Studies

Pulmonary Hypertension

Pulmonary Arterial Hypertension/ Parenchymal Lung Disease:

TITLE:  A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease

PROTOCOL NO.:    RIN-PH-201

This study is investigating a medicine called inhaled treprostinil (brand name Tyvaso®).  In this form, inhaled treprostinil or placebo will be referred to as “study drug.”  Placebo is made to look exactly like inhaled treprostinil but does not contain the active ingredient (treprostinil).  Instead, it will pass through your body without affecting your symptoms of PH or any other body system.  The study drug is given by inhaling (breathing in) the medicine into your lungs using a machine called a nebulizer (inhaling device).  The nebulizer changes the medicine into a mist for you to breathe into your lungs.

Inhaled Treprostinil works by keeping the pulmonary arteries open and working properly so there is less strain on the heart.

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Protocol E2006-G000-303

Title:   This is a long-term (approximately 1 year), multicenter, randomized, controlled, double-blind, parallel group study of two doses of lemborexant and placebo in approximately 900 male or female participants with insomnia disorder. Approximately 40% of participants will be age 65 years or older. The study will last a maximum of 59 weeks and will include a Screening Period, an approximately 54-week Treatment Period (during which study medication will be administered), and a 2-week Follow-up Period. All participants will receive lemborexant for at least 6 months and will receive placebo at some point during the study. Participants will not know which medication they receive (lemborexant or placebo), and will not know the timings at which the medication will change.

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Study details

Categories:

Human Clinical Trail

PROTOCOL NO.: Ajinomoto AminoIndex™ 2015-01

TITLE: A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology

This is a prospective, multi-center study to evaluate the diagnostic performance characteristics of the AminoIndex™ technology among patients at high risk of developing lung cancer as compared with standard lung cancer screening and diagnostic procedures including low-dose CT, high-dose CT, biopsy, and histopathology.

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