Therapeutic Expertise: Respiratory

RESPIRATORY SOLUTIONS

MERIT offers reliable, agile, and attentive centralized spirometry expertise. 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

Tell us about your project


    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 review 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 INCLUDE:

    • Centralized Spirometry Services
      • Spirometry QC & Reading
      • Standardized Equipment
    • Data Acquisition and Review
      • Spirometry Data Management
      • Configurable Software Solution
    • Site & Study Management
      • Training, Logistics, & Support

    SPECIALIZED DATA COLLECTION SERVICES INCLUDE:

    Serial Spirometry

    Reversibility

    MBPC

    FeNO

    DLCO

    Exercise Challenge

    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 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

    CARDIAC SAFETY SERVICES

    MERIT provides standardized collection and review of cardiac safety data, often an important safety endpoint in respiratory trials. For example, many respiratory trials require a normal ECG at screening at a minimum, and others require certain QTcF or QTcB cutoffs for inclusion/exclusion criteria.

    ADVANTAGES TO MERIT’S CARDIAC SAFETY SERVICES:

    • Easily collect ECGs and spirometry in the same system
    • High quality capture
    • Electronic, centralized ECG system
    • Fully traceable 21 CFR Part 11 compliant system
    • All ECG data can be accessed anywhere in the world
    • MERIT team of cardiologists for expert central review

    ECGs are captured directly via USB, and ECGs are transmitted as soon as the site saves the tracing. An ECG auto-interpretation is immediately available and allows for quick identification and response to any errors.

    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.

    WHY MERIT?

    Transparent communication with prompt access to in-house experts

    Deep bench of experienced and tenured staff trained in industry sponsored clinical trials, with a dedicated team for every project

    We are often able to provide competitive pricing and shortened timelines for our sponsors and partners through efficiences gained from decades of experience

    Proven track record supporting FDA approval of numerous products

    MERIT’s innovative respiratory software application, CompleClinical®, simplifies and streamlines the pulmonary clinical trial process, improving the efficiency and accuracy of data capture, management, and grading of spirometry data

    Personalized attention, scalable solutions, and reliable clinical trial endpoint services

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

    Management

    Services

    Capabilities

    Software

    TELL US ABOUT
    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.