Welcome to Clinical Research Specialists
Our research team is composed of medical professionals with over 40 years of clinical research experience. We believe that by providing disease-specific education, monitoring, and support, every volunteer will leave a clinical research trial with a better understanding of how to manage their illness.
Clinical Research Specialists, LLC, understands how important clinical trials are to our patients and our sponsors. We extend our services to research patients, sponsors, physicians, and CROs. We are committed to exceeding our enrollment goals.
Stages of Research
Once a medication, device or treatment has been developed, it must be tested. Clinical trials allow us to explore how a medical method interacts with the human body. Clinical trials are used to determine whether a specific method can be deemed safe and effective for human use. This mission is the basis of all 4 phases of a clinical trial.
First Safety Study with 20-100 healthy volunteers
Hundreds of volunteers receive multiple doses to study efficacy
Long term trial with thousands of volunteers to prepare for FDA approval
Post marketing, once the FDA approves the medication, device, treatment, etc.
Taking part in a clinical research study is entirely voluntary.
In order to ensure you understand what is involved with a clinical trial, participants receive an informed consent document.
This document provides an overview of the study procedures, a study schedule, and answers to common questions about clinical trials.
Currently Enrolling Studies
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants with Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis (FRONTIER 4)
ClinicalTrials.gov Identifier: NCT04631016
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Chronic Obstructive Pulmonary Disease and Chronic Bonchitis.
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.
A Multi-Centre, Single Arm, Open-Label Extension Study to Evaluate the Long-Term Safety of GSK3511294 in Participants with Severe Asthma with an Eosinophilic Phenotype
ClinicalTrials.gov Identifier: NCT04718103
This study will assess the efficacy and safety of GSK3511294 as an adjunctive therapy in participants with severe uncontrolled asthma with an eosinophilic phenotype despite standard of care (SoC) treatment with medium to high dose inhaled corticosteroid (ICS) plus at least one additional controller.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study
ClinicalTrials.gov Identifier: NCT04594369
The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.
A Phase III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Prm-151 in Patients with Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov Identifier: NCT04552899
This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).
ARISE – A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
ClinicalTrials.gov Identifier: NCT04677543
The primary objective of this study is to generate evidence demonstrating the domain specification via modern psychometric methods, reliability, validity, and responsiveness of Quality of Life – Bronchiectasis (QoL-B) and Patient-Reported Outcome Measurement Information System – Fatigue-Short Form (PROMIS F-SF 7a) in participants with newly diagnosed nontuberculous mycobacterial (NTM) lung infection caused by Myobaxterium avium Complex (MAC).
A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
ClinicalTrials.gov Identifier: NCT04677569
The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + Azithromycin + Ethambutol compared to the ELC (empty liposome control) + Azithromycin + Ethambutol on participant reported respiratory symptoms at Month 13.
SEER-Lung: A Prospective Blood Sample Collection Study to Develop and Validate a Panel of Protein-based Biomarkers in Patients with Pulmonary Nodules
The objective of this study is to develop a panel of blood-based protein biomarkers for the characterization of lung nodules in patients with intermediate risk lung nodules considered for biopsy. This is a prospective, multicenter minimal-risk sample collection study that will develop and validate the accuracy of a blood-based panel of protein biomarkers for use in patients with lung nodules who are considered for biopsy.
Future Enrolling Studies
Clinical research is the process of determining whether a medication, device, therapy or treatment is safe and effective for human use. These studies can be used to prevent, diagnose and treat illnesses
- Lung cancer
- Pulmonary hypertension
- Atrial fibrillation
- Rheumatoid arthritis
- Heart failure