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Services

  • Centralized Data Capture

    Powerful Centralized Data Capture

    Vitalograph Spirotrac Software in combination with expert over-reading, reporting and site training maximises overall data quality. Our objective is to maximize the percentage of 'acceptable' sessions (as defined by ATS/ERS guidelines).

    Spirotrac Software provides the investigator with a user-friendly and intuitive data collection platform that results in accurate and reliable data collection. Data is sent automatically and securely to the Vitalograph Data Management Centre for review by expert Over-Readers. Both our generic and customized data reports are then disseminated via web-based reporting, providing fast, seamless assessment of data quality to the sites and the sponsor. The data can also be transmitted directly to the sponsor's own data management system and can be integrated with an e-CRF system in the required format.

    Spirotrac Software in combination with expert over-reading, reporting and site training maximises overall data quality. Spirotrac can be customized for each study with specific feedback tailored to the protocol to facilitate a wide range of measurements and data collection parameters including spirometry, DLCO, FENO, ABPM, Holter, cough, cardiac safety and patient reported outcomes (PRO).

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  • Global Support

    24/7 Global Support

    As a global manufacturer of cardio-respiratory testing equipment and customized software, Vitalograph are well placed to understand the modern day challenges and logistical implications of running multi-national trials. Our expertise is complemented by a customer focused, 24 hour, multi-lingual support team service trained in the specifics of each protocol in order to deliver the best support for our customers.

  • Expert Training

    Comprehensive Expert Training

    Our expert training staff will design and deliver a customized training program covering the relevant testing guidelines and regulations, protocol specific testing and test quality requirements for your trial. Our training programs are designed to enhance technician proficiency, resulting in decreased risk of protocol infringements, improved data quality and higher confidence in your endpoint measurements. Training can be delivered in person at investigator meetings, remotely or online.

  • Project Management

    Customized Project Management

    Our project management expertise ensures that studies run to scope, schedule and budget with ongoing assessment and management of risks. Each study is assigned a dedicated and skilled project manager supported by a project delivery team, experienced in the conduct of cardio-respiratory clinical trials.

    • Study management: project management, project analysis and reporting
    • Consultation: protocol review and electronic quality review of pulmonary function tests and query resolution
    • Development of requirements for study-specific software design
    • Data Management: database design, validation, maintenance and reporting
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  • Reporting

    Fast, Efficient Reporting

    Our project team are able to provide sponsors, CRAs, and site staff with up to the minute reports from the centralized study database delivered via email or accessible online using the Vitalograph VIEWER web portal.

    In order to monitor subject enrolment, study technician performance and subject compliance, study specific metrics and data reports are available to the sponsor at any time, by country, site and subject. All Vitalograph reports can be customized to your requirements and typically include:

    • Cardiac and respiratory testing QA review
    • Site technician performance
    • Subject visit status
    • Subject alerts
    • Subject compliance
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  • Consultation

    Consultation Services

    Vitalograph collaborates closely with a wide range of international cardio-respiratory experts and regulatory bodies on the development of performance standards and regulatory requirements for medical devices and the conduct of respiratory testing. This expertise means we can offer you guidance on the optimum data collection and logistical strategies to ensure a successful outcome for your clinical trial.

  • Systems and Processes

    Rigorous Systems and Processes

    Our robust quality management system (QMS) is designed to protect the integrity and success of your trial.

    • Compliant with ICH/GCP, and ISO requirements
    • Fully validated data management systems with in-built in redundancy at multiple Vitalograph locations – everything is automatically backed up and continues to operate seamlessly in the unlikely occurrence of an adverse event
    • Automatic data back-up in all site systems including e-diaries
    • Encrypted data transmission system – highly secure, fast and cost effective via a local broadband connection from clinic or home
    • Web-based, on-demand access to data and reports – a powerful tool for monitoring the progress of your study using Vitalograph VIEWER
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  • Web Services

    Web Services - PFT Web Capture System

    This innovative web portal and electronic data capture system provides web services for effective monitoring of the study by study managers and CRAs. PFT Web Capture is designed to provide fast, secure data capture with centralized QA review without the need to invest in standardized high cost capital equipment or lengthy training.

    The system can be tailored to suit your exact needs and its versatility can meet the requirements of any primary or secondary endpoint. Vitalograph provides custom step-by-step software for each site to quickly complete a web page either on or off line. This data can include reports, graphs and images produced by equipment already in use at the site, whether electronic or on paper. The Vitalograph team checks that data entry from each site is correct before the new data is accepted into the central database on the web server. In this way clean data is captured throughout the study with fast data-lock after LPLV.

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