MGC Diagnostics: Project Management Team

Project Management Team

Each member of the MGC Diagnostics Project Management Team is a Registered Pulmonary Function Technologist (RPFT) with more than 20 years of extensive clinical experience. The Team works with the client to ensure efficient and precise protocol review and study management. Sharing best practices enables the Team to function seamlessly across various departments including: Project Management, Technical and Customer Support, Education and Training, Software Development and Data Management.

ATS/ERS Standards provide guidelines for attaining accurate, consistent, and quality data. For over 35 years, MGC Diagnostics through its subsidiary Medical Graphics Corporation has manufactured research-quality respiratory devices in compliance with these guidelines. The Company is positioned to continue to meet these regulatory requirements and provide customized software that adheres to stringent protocol requirements. MGC Diagnostics also offers flexible equipment purchase or rental options.

MGC Diagnostics device selection offers basic spirometry testing as well as Peak Flow with MIR Spirotel® eDiary and Diffusion Capacity and Lung Volume testing. Set-up of equipment can be demonstrated at the Site Investigator Meeting via webcast or depending on the device(s) used in the study, comprehensive on-site installation may be required. Maintenance of the equipment is also provided for the duration of the study.

MGC Diagnostics through its subsidiary Medical Graphics Corporation has been manufacturing medical devices for over 35 years and providing equipment for clinical trials since 1984. The Company has been the clear choice of providers for 36 of the Top 40 Respiratory Teaching Hospitals in the United States.

Each study is assigned a dedicated Clinical OverRead Team member who then becomes an integral member of a larger Project Management Team. This process ensures consistency for all test reviews for the duration of the study. During the study start-up time frame before First Patient First Visit (FPFV), the assigned OverRead Team member is fully engaged in developing a protocol-specific OverRead Plan for the study.

All Pulmonary Function Tests (PFTs) are reviewed for quality and acceptability based on ATS/ERS guidelines and study protocol requirements. Data queries are generated for submission to the sites and responses are tracked and managed for timely query resolution. Reports can be customized and returned to the sites via fax or online within 24-48 hours. Feedback to sites regarding the quality of data is provided on a continuing basis to help improve site performance. All PFT efforts are first evaluated for acceptability. Acceptable efforts are next evaluated for repeatability. Each test will then be given a quality score which can be visible to the client and/or site as part of MGC Diagnostics on-going Quality Review process.

When purchasing or renting a MGC Diagnostics system for clinical trial, we offer complete system training with centralized and on-site support programs. This service comes with the assurance that our goal is to deliver the ultimate in quality service and accurate reliable research data.
 
A vital component in acquiring the best quality pulmonary function data is the training aspect for site Respiratory Technicians in order to properly coach their patients through the PFT testing. The data quality is highly dependent on the cooperation of the patient and proper instruction. In most respiratory trials, the Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) parameters are study endpoints and are subject to slight variations in the performance of the maneuver.

MGC Diagnostics primary focus is providing clients with a variety of training and educational options to fit each study’s logistical and financial need; including on-site Investigator meetings and web-based modules. Early on, during the initial client meeting, MGC Diagnostics will customize training materials and plan for equipment logistical support for training meeting(s). MGC Diagnostics will train each of the site technicians and/or coordinators. Site Certification is available during the Investigator Meeting, on-site, or on-line via our web-based modules.

MGC Diagnostics is committed to supporting research sponsors and clinical sites through quality service and technical support. With Regional Service Engineers stationed throughout the country and application Support Specialists in our home office, we provide experienced staff to answer your technical questions on a global 24/7/365 basis, via our toll free service line. The Support Specialists are trained on the specifics of your protocol during the study start-up and are an integral member of the Project Management Team.

Technical Support can also be contacted via the internet using our Online Support. Customer Support can provide remote desktop access and respond to incoming requests for assistance within 2 minutes, to ensure timely follow-up with the site.

standardization

ATS/ERS Standards provide guidelines for attaining accurate, consistent, and quality data. For over 35 years, MGC Diagnostics through its subsidiary Medical Graphics Corporation has manufactured research-quality respiratory devices in compliance with these guidelines. The Company is positioned to continue to meet these regulatory requirements and provide customized software that adheres to stringent protocol requirements. MGC Diagnostics also offers flexible equipment purchase or rental options.

MGC Diagnostics device selection offers basic spirometry testing as well as Peak Flow with MIR Spirotel® eDiary and Diffusion Capacity and Lung Volume testing. Set-up of equipment can be demonstrated at the Site Investigator Meeting via webcast or depending on the device(s) used in the study, comprehensive on-site installation may be required. Maintenance of the equipment is also provided for the duration of the study.

MGC Diagnostics through its subsidiary Medical Graphics Corporation has been manufacturing medical devices for over 35 years and providing equipment for clinical trials since 1984. The Company has been the clear choice of providers for 36 of the Top 40 Respiratory Teaching Hospitals in the United States.

overread

Each study is assigned a dedicated Clinical OverRead Team member who then becomes an integral member of a larger Project Management Team. This process ensures consistency for all test reviews for the duration of the study. During the study start-up time frame before First Patient First Visit (FPFV), the assigned OverRead Team member is fully engaged in developing a protocol-specific OverRead Plan for the study.

All Pulmonary Function Tests (PFTs) are reviewed for quality and acceptability based on ATS/ERS guidelines and study protocol requirements. Data queries are generated for submission to the sites and responses are tracked and managed for timely query resolution. Reports can be customized and returned to the sites via fax or online within 24-48 hours. Feedback to sites regarding the quality of data is provided on a continuing basis to help improve site performance. All PFT efforts are first evaluated for acceptability. Acceptable efforts are next evaluated for repeatability. Each test will then be given a quality score which can be visible to the client and/or site as part of MGC Diagnostics on-going Quality Review process.

training

When purchasing or renting a MGC Diagnostics system for clinical trial, we offer complete system training with centralized and on-site support programs. This service comes with the assurance that our goal is to deliver the ultimate in quality service and accurate reliable research data.
 
A vital component in acquiring the best quality pulmonary function data is the training aspect for site Respiratory Technicians in order to properly coach their patients through the PFT testing. The data quality is highly dependent on the cooperation of the patient and proper instruction. In most respiratory trials, the Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) parameters are study endpoints and are subject to slight variations in the performance of the maneuver.

MGC Diagnostics primary focus is providing clients with a variety of training and educational options to fit each study’s logistical and financial need; including on-site Investigator meetings and web-based modules. Early on, during the initial client meeting, MGC Diagnostics will customize training materials and plan for equipment logistical support for training meeting(s). MGC Diagnostics will train each of the site technicians and/or coordinators. Site Certification is available during the Investigator Meeting, on-site, or on-line via our web-based modules.

support

MGC Diagnostics is committed to supporting research sponsors and clinical sites through quality service and technical support. With Regional Service Engineers stationed throughout the country and application Support Specialists in our home office, we provide experienced staff to answer your technical questions on a global 24/7/365 basis, via our toll free service line. The Support Specialists are trained on the specifics of your protocol during the study start-up and are an integral member of the Project Management Team.

Technical Support can also be contacted via the internet using our Online Support. Customer Support can provide remote desktop access and respond to incoming requests for assistance within 2 minutes, to ensure timely follow-up with the site.

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MGC Diagnostics and its affiliates are equal opportunity/affirmative action employers committed to cultural diversity in the workplace and complies with Executive Orders 11246 and 13496 and hereby provides notice of its compliance with FAR 52-222-26, 29 CFR Part 471, Appendix A to Subpart A, 41 C.F.R. 60-1.4, 41 C.F.R. 60-250.5, and 41 C.F.R. 60-741.5.