Lung Disease (ILD) | Respiratory Expertise

What Vitalograph Offer

Our Experience

Objectives & Endpoints

What Vitalograph Offer

We work to the specific requirements of your study needs, with a centralized, fully adaptable spirometry system. Clinicians can capture pulmonary function testing data and measure the impact of the fibrosis in clinical trial subjects, and resting spirometry and gas transfer measurements can be entered on our system, and included as part of the central database.

We offer a range of centralized pulmonary function testing (PFT) endpoints and customizable reports for data monitoring and analysis, and quick and easy access to subject matter experts throughout the life of your study.

We provide you with:

eCOA
Over-read 360 (QA Review) for spirometry and DLCO providing prompt feedback to sites, to improve data quality.
The 6MWT to assess subject’s functional capability.
Home monitoring patient reported outcome questionnaires and spirometry measurements on our handheld In2itive^TM eDiary, e.g. EQ-5D-5L, SGRQ.
Customizable reports for data monitoring and analysis.
Access to subject matter experts throughout the life of your study.
Clinical trial devices and software.
Professional and dedicated study services.

Our Experience

Choosing Vitalograph® gives you the benefit of our renowned expertise in interstitial lung disease studies.

We support Interstitial Lung Disease clinical trials including Idiopathic Pulmonary Fibrosis, Sarcoidosis and Scleroderma. Vitalograph is the Interstitial Lung Disease study partner of choice for many leading pharmaceutical companies and CROs, who regularly come back to us for repeat business.

Being a market leader in respiratory medical devices for over 50 years, we have a wealth of expertise in respiratory testing and monitoring. We also know the importance of accuracy in study endpoints and safety, and provide data you can rely on.

Our internationally renowned Over-readers ensure high-quality data and feedback for your trial, improving site data, compliance and performance.

Our experienced teams of highly qualified and responsive project and data managers mean decisions can be made quickly. We are flexible in our approach and, being fully aware of the importance of timelines, prompt feedback is provided for any query. We ensure key milestones are met and trials are delivered speedily.

Objectives & Endpoints

We provide accurate, reliable and precise Interstitial Lung Disease clinical trial objectives and endpoints.

Criteria	Example Endpoints
Subjective Endpoints	Symptom Scores (Dyspnoea) Example pre-validated eCOA and ePRO on our In2itive™ e-Diary: EQ-5D-5L on In2itive e-Diary, SGRQ on COMPACT Medical Workstation. Other eCOA and questionnaires can be integrated to meet study needs. Custom endpoints available
Objective Endpoints	PFT including: In-clinic Lung Function tests Pre & post study drug spirometry Spirometry: FVC FVC % pred FEV1 FEV1 % predicted FEV1/FVC ratio Home spirometry for FEV1, FVC Centralized DLCO data Exacerbations / study alerts Cough Counts 6MWD