- Clinical Research
MGC Diagnostics Clinical Research has been a global provider of Centralized Respiratory Services for adult and pediatric clinical trials since 1984. In the past 5 years, we have supported and provided equipment and services for over 50 studies and 1,500 sites, collected data from more than 10,000 subjects, and processed and reviewed over 50,000 flow-volume loops and 7,500 MIR Spirotel® eDiary sessions. The MGC Diagnostics Project Team is all Registered Pulmonary Function Technologists (RPFTs) with an average of 20 years clinical experience. With strict adherence to Quality Control processes and identifying cost-efficiencies upfront, our goal is to ensure that we deliver the highest quality data on time while offering the best possible pricing per study.
The MGC Diagnostics solution begins with a review of the protocol to determine the services and devices needed to collect, analyze and review data. Whether or not standardized respiratory devices are used, a centralized approach to review and analyze the data may still be attained with site-owned equipment.
Customized software will be programmed and implemented to ensure uniform measurements across all devices, and will include identical protocol inclusion and exclusion criteria and screen alerts. Protocol-specific training and User Manuals are also developed for the Investigators and Site Coordinators. The MGC Diagnostics Project Team will implement a Quality Test Review Plan, including protocol compliance monitoring for ongoing oversight of the study. Additionally, a protocol-specific Data Management Plan will be developed and implemented, ensuring accurate, secure and timely data transfers. Site and Customer Support lead the initial client meeting with an in-depth discussion of site locations, logistical considerations and site initiations and trainings. Continued throughout the study duration, the MGC Diagnostic Team is available 24 hours a day, 7 days a week, and 365 days a year.