Therapeutic Expertise: Respiratory

RESPIRATORY SOLUTIONS

MERIT offers reliable, agile, and attentive centralized spirometry overreads. Our processes have been refined and standardized from our over 30 years’ experience conducting respiratory trials. This often results in competitive pricing and shortened timelines for our sponsors and partners. We prioritize a collaborative, partnership-driven approach for all projects with scalable solutions and personalized attention.

With MERIT, you benefit
from the following:

  • Agile team – gain fast and flexible responses from our tenured team
  • Collaborative, swift solutions – our qualified respiratory therapists can be contacted with one simple phone call or email
  • Easily configurable software – highly customizable workflows that help facilitate rapid study startup and enrollment
  • Continuous data access – all study stakeholders have access to the current study data on an ongoing basis

Some companies tend to overpromise and underdeliver, which puts your study success at risk. If you’re looking for a spirometry services provider that will value your partnership and make your study a priority, consider MERIT.

“MERIT was a very valuable partner in our phase 2/3 program as the central spirometry vendor. The oversight they provided to this important component of the program was a key factor in its success. To not use a vendor such as MERIT in a large respiratory program would make executing the studies much more difficult and greatly limit our confidence in the spirometry data.”

-SPONSOR, LEADING BIOPHARMACEUTICAL COMPANY

RESPIRATORY SERVICES

MERIT’s standardized collection and consistent interpretation of respiratory data enhances accurate, actionable outcomes. By centralizing your spirometry overreads with MERIT, you can be sure your data is in the hands of qualified respiratory therapists who are committed to personalized service. MERIT offers reliable solutions and a responsive partnership for Phase I-IV, pharmacokinetic, and bioequivalence respiratory clinical studies.

OUR CORE RESPIRATORY SERVICES

  • Centralized Data Capture
  • Spirometry Review & Grading
  • Configurable Software Solution
  • Spirometry Data Management
  • Instruction Manuals
  • Logistics & Site Support

SPECIALIZED DATA COLLECTION SERVICES INCLUDE:

Site Engagement Infographic

What if you could fully-engage sites in every stage of a respiratory clinical trial from startup to conductance to closeout so that your next study completed ahead of time and under budget? Take a look at a few metrics from one of our methacholine challenge bioequivalence studies.

SPIROMETRY SIMPLIFIED. Our qualified respiratory therapists can be contacted with one simple phone call or email. Sites get the swift assistance they need without waiting on hold or for a return phone call that never comes. Sponsors benefit with improved subject qualification and retention at screening and throughout the study.

RESPIRATORY EXPERTISE

Whether studying a novel treatment for COPD or performing a generic bioequivalence study for asthma, most pulmonary clinical trials include spirometry as a primary endpoint. Our expertise in centralized spirometry supports the actionable results required to move your trial forward, and includes:

Centralized spirometry overreads by Registered Respiratory Therapists (RRT) team using configurable, standardized grading to confirm & adhere to protocol and ATS/ERS standards

Uniformly sourced and rigorously tested equipment with study-specific manuals provided to each site

Proprietary spirometry software enables real-time acquisition of data, empowering faster quality control and a more efficient site query process

Hands on training for all users with clear instructional materials including manuals, videos, and webinars

RESPIRATORY STUDIES BY INDICATION

RESPIRATORY EXPERIENCE BY THE NUMBERS

RESPIRATORY CASE STUDIES

RESPIRATORY SOFTWARE

MERIT’s innovative software application, CompleClinical®, simplifies and streamlines the respiratory clinical trial process, improving the efficiency and accuracy of data capture, management, and grading of spirometry data. Our software features highly customizable workflows that help facilitate rapid study startup and enrollment. CompleClinical provides audit trail tracking and is HIPAA and 21 CFR Part 11 compliant.

RESPIRATORY DISEASE STATES

ASTHMA

Asthma is a chronic disease in which the airways in the lungs narrow and swell, causing labored breathing, wheezing, chest tightness, and cough.

COPD

Chronic Obstructive Pulmonary Disease (COPD) is a group of progressive lung disorders characterized by increasing breathlessness including emphysema and chronic bronchitis.

ALLERGIC RHINITIS

Allergic rhinitis is an allergic response to environmental allergens such as pollens, weeds, dust mites, pet dander, insects, and molds that causes sneezing, nasal congestion, itchy nose, and sore throat.

EIB

Exercise-Induced Bronchoconstriction (EIB) is a temporary narrowing and inflammation of the airways of the lung due to physical activity. Symptoms include shortness of breath, wheezing, coughing, and chest tightness.

CYSTIC FIBROSIS

Cystic fibrosis is an inherited life-threatening disease caused by a defective gene that affects cells that produce mucus, digestive juices, and sweat. It is a progressive disease that damages the lungs, pancreas, and other organs.

IDIOPATHIC PULMONARY FIBROSIS

Idiopathic Pulmonary Fibrosis (IPF) is a progressive and irreversible lung disease characterized by the development of scar tissue (fibrosis) in the lungs. The term “idiopathic” means that the cause of the condition is unknown. IPF is categorized as a restrictive lung disease due to the decrease in lung elasticity. Scarring of the lung tissue makes the lungs become stiff, therefore expanding less, and decreasing overall lung function and oxygen update.

Solution Guides

preview of solution guide pdf
MERIT Respiratory Solutions Guide
preview of solution guide pdf
MERIT Respiratory Partnerships Guide

Leadership

Services

Capabilities

Software

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YOUR PROJECT

Connect with us to learn more about how our expertise and approach can support bringing your product to market on-time and on-budget. Your success is our priority.