MERIT’s spirometry and MBPC expertise form the cornerstone for successful Phase III bioequivalence study for generic asthma treatment....
Therapeutic Expertise: Respiratory
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
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
RESPIRATORY CASE STUDIES
MERIT’s spirometry expertise and quality overreads lay the foundation for successful multi-study COPD drug development program....
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.
