Vitalograph Clinical Trials Services

Cardio-respiratory device manufacturer and service provider for your clinical trial needs.

Our heritage

We at Vitalograph are proud of our 50-year heritage as a world-leading respiratory specialist. Our pioneering spirit has led us to develop a number of innovative respiratory devices, including the first ever spirometer designed for use in primary care. This same commitment to innovation is reflected in our wide range of clinical trials services. Vitalograph has continued to be privately owned since the day the company was founded. This continuity of management has resulted in a clear and consistent corporate vision, as well as a reassuring speed of response that comes from a stable and financially strong organisation.

Our future

Today, Vitalograph is a leading global provider of respiratory products and services with offices and a network of expert distributors around the world. Employing over 200 employees dedicated to cardio-respiratory diagnostics and clinical trials, Vitalograph works in close collaboration with a wide range of international respiratory experts, pharmaceutical companies and CROs to ensure the efficient capture of high-quality cardio-respiratory data around the world.

We also continue to improve the quality of spirometry worldwide through our involvement in the development of CEN and ISO performance standards for respiratory measuring devices. Since 2006, we have been involved in over 50 clinical trials, delivering spirometry equipment to over 3,000 sites in over 50 countries, and we continue to grow from strength to strength.

Our people

Our people are committed to delivering the highest possible standards of customer care and are constantly seeking new ways to improve our service. In addition to friendliness, professionalism and flexibility, our highly-trained clinical trials team provides a breadth of experience in the delivery of multi-centred global trials, on time and within budget. They also have an in-depth understanding of ICH-GCP and the ATS/ERS requirements for pulmonary-function testing in clinical trials.

We are committed to providing the highest level of service and equipment for clinical trials, to meet the endpoints and measurement outcomes of your respiratory study, including:

Centralised PFTs and data capture services:

• Equipment rental or purchase for clinic and home based measurements
• Spirotrac® spirometry and In2itive™ e-Diary
• Integrated challenge testing

SpO2 NIBP:

• Integrated ECG services with over-reading by expert cardiologists
• Integrated FeNO data capture
• QA review by world-leading PFT experts to maximise data quality and provide detailed feedback on all tests
• Complete data reporting including our secure web-based, on-demand, VIEWER™ reports portal
• Project and data management, including protocol review, software customisation, 24/7 support and training services
• Stand-alone equipment for non-centralised studies

Our rigorous systems and processes

We have developed a wide range of sophisticated systems and processes to protect the security and success of your trial, including:

• Secure data transfer of trial data from clinic or subject’s home for home-based spirometry recording and patient reported outcomes
• Vitalograph recently passed its first routine inspection by The Medicines and Healthcare Products Regulatory Agency (MHRA). The Agency reported zero critical findings and zero major findings. Vitalograph was one of only 5% of CROs to pass with this degree of success. In addition to this audit success, the latest FDA routine inspection of the Vitalograph research and manufacturing facility in Ireland was also a great success, again with zero deficiencies {483s} raised
• Mirrored data management system at a second Vitalograph location whereby everything is automatically backed up, continues to operate seamlessly in the unlikely event that the primary system fails
• Automatic data backup memory card in all site systems and in the In2itive e-Diary, makes it simple to create alterations in the event of a fault and restore with all data intact
• Web-based, on-demand access to data and reports: a powerful tool for monitoring the progress of your study using the viewer

Project management

Our project management expertise ensures that studies run to specification and schedule and that all steps involved in successful completion are conducted with ongoing analysis and management of risks to GCP. Each study is assigned a dedicated project manager with several years of experience in respiratory clinical trials. Project managers ensure that the following activities are tailored to suit the needs of each study:

• Study management: to include project management, project analysis and reports to the sponsor
• Spirometry consultation: to include protocol review and electronic quality review of pulmonary-function tests and query resolution
• Data management: based at Vitalograph Ltd, Buckingham, UK. This includes secure daily back-ups and a "mirrored" system at Vitalograph Ltd, Ennis, Ireland; data edit checking and corrections; online monitoring and reporting