Clinical Research

A global provider of Centralized Respiratory Services for adult and pediatric clinical trials since 1984.

The Project Management Team

Each member of the MGC Diagnostics Project Management Team is a Registered Pulmonary Function Technologist (RPFT). The Team works with the client to ensure efficient and precise protocol review and study management. 

Each study is assigned a dedicated Clincial OverRead Team member for the duration of your study. Having a dedicated team member assigned to your study will ensure consistency for all test reviews.

Clinical Research Solutions – How it works

The MGC Diagnostics Project Team begins with an initial in-depth client meeting discussing site locations, logistical considerations and site initiations and trainings. These periodic meetings will occur throughout the study duration.

The project kicks-off with a review of the protocol to determine the services and devices need to collect, analyze, and review data. Standardized respiratory devices or site-owned equipment is used to collect data, which is then reviewed using a centralized approach. 

We use a customized approach with every project. 

Our software is custom programmed and implemented for each study to ensure uniform measurements across all devices, and will include identical protocol inclusion and exclusion criteria and screen alerts. We develop protocol-specific training and user manuals for the Investigators and Site Coordinators. 

You can be confident with the quality of the data collection and management.

The MGC Diagnostics Project Team implements a Quality Test Review Plan, including protocol compliance monitoring for ongoing oversight of the study. Additionally, a protocol-specific Data Management Plan is developed, ensuring accurate, secure and timely data transfers. All Pulmonary Function Tests (PFTs) are reviewed for quality and acceptability based on ATS/ERS guidelines and study protocol requirements. Feedback to sites regarding the quality of data is provided on a continuing basis to help improve site performance.

The MGC Diagnostics Project Team is available for support 24 hours a day, 7 days a week, and 365 days a year.

Technology

We offer highly customizable devices and software configurations and solutions. We offer flexible system purchase or rental options for your clinical research study.

Spirometer
The CPFS/D USB™ spirometer has measurement accuracy and performance that meets ATS/ERS standards and is Title 21 CFR Part 11 and HIPAA compliant. With a full audit trail component, role-based security and electronic signatures, the CPFS/D USB™ spirometer is a complete, research-quality device. Having a Windows®-based platform, it is easy to use and upgrade, and supports the integration of other test devices such as Peak Flow with MIR Spirotel® eDiary.
> Learn more about the CPFS/D USB spirometer

Plethysmography
The Platinum Elite™ body plethysmograph is an accurate, compact and comfortable device with complete spirometry, RTD™ real-time diffusion with multi-gas technology and lung volumes via body plethysmography. The Platinum Elite™ body plethysmograph is the ‘Gold Standard’ to measure residual volume, functional residual capacity and total lung capacity.
> Learn more about te Platinum Elite body plethysmograph

Complete Pulmonary Function Test
The Ultima PF™ pulmonary function system is a complete pulmonary function device with RTD™ real-time diffusion with multi-gas technology and lung volumes via N2 washout. MGC Diagnostics offers the latest technology saving the client time and money. The Ultima Series™ cardiopulmonary diagnostic systems are available in desktop or mobile configurations.
> Learn more about the Ultima PF pulmonary function system

FOT
With just normal breathing from the patient, the Resmon™ Pro V3 can measure the mechanical properties of the respiratory system and provide a simple, effort-independent assessment of airways obstruction, characterizing peripheral, and central or heterogeneous patterns. The Resmon Pro V3 is ideal for virtually any testing environment—including pulmonary laboratories, private offices, on-site school or workplace settings and sites for clinical trials or research studies.”
> Learn more about the Resmon Pro V3 FOT system