Services

Centralized Data Capture

Powerful Centralized Data Capture

Vitalograph's unique Spirotrac Software, in combination with expert over-reading, reporting and site training, maximizes overall data quality and reduces sources of variability or errors. Spirotrac provides standardized systems across all sites and 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 (ePRO).


24/7 Global Support

As a leading manufacturer of cardio-respiratory testing equipment and customized software, with global study experience, Vitalograph is 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 trained in the specifics of each protocol in order to deliver the best help desk support for our partners.

Global Support

Expert Training

Comprehensive Expert Training

Our expert training staff will design and deliver a custom training program focusing on 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 end-point measurements. Training can be delivered in person at investigator meetings, remotely or online.


Dedicated 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 with experience in the conduct of cardio-respiratory clinical trials.

Project Management

Reporting

Fast, Efficient Reporting

Our project team is able to provide sponsors, CRAs and site staff with real-time custom reports from the centralized study database. Reports are delivered directly to site systems, via email or accessible online using the Vitalograph VIEWER web portal.

Study specific metrics and data reports are available to sponsors at any time, by country, site and subject.


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 cardiac and respiratory testing. This expertise means we can offer guidance on the optimum data collection and logistical strategies to ensure a successful outcome for your trial.

Consultation

Systems and Processes

Rigorous Systems and Processes

Our robust Quality Management System (QMS) is designed to protect the data integrity and success of your trial. Features include:

  • Full compliance with ICH/GCP and ISO requirements
  • Fully validated data management systems with built-in fail-over systems at multiple Vitalograph locations - everything is automatically backed up and continues to operate seamlessly in the unlikely occurrence of an unexpected failure of any individual system
  • Automatic data back-up in all site devices including e-diaries
  • Encrypted data transmission system – highly secure, fast and cost effective via the clinic's broadband connection or via GSM from the patient's home
  • Web-based, on-demand access to data and reports - a powerful tool for monitoring the progress of your study using Vitalograph VIEWER

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 where study needs or budget constraints do not cover standardized equipment or specific device training.

The system can be tailored to suit your exact needs and its versatility can meet the requirements of any primary or secondary endpoint.

Web Services