Rare Disease Studies

Supporting rare and orphan lung disease clinical trials.

What Vitalograph Offer
Our Experience
Objectives & Endpoints

What Vitalograph Offer

We offer a full range of specialized pulmonary function tests supported by key opinion leaders. We are flexible and work with you to develop customized solutions for the unique nature of trials in rare and orphan diseases.

We provide:

  • Over-reading (QA review) for spirometry and MIP/MEP.
  • NIOX VERO ® centralized FeNO data capture to assess underlying inflammation.
  • Respiratory Muscle Strength assessment.
  • Specialized tests to measure peak cough flow (PCF), IFR, SNIP.
  • Home monitoring through patient reported outcome questionnaires and lung function endpoints.
  • eCOA and ePRO through our In2itive e-Diary to meet study needs.
  • Adaptable reports for data monitoring and analysis. 
  • Access to subject matter experts throughout the life of your study
  • Software is adapted to modified ATS/ERS criteria for the study population
  • Clinical trial devices and software.
  • Professional and dedicated study services.

Our Experience

We have extensive experience in supporting niche studies and Rare Disease respiratory clinical trials.

We have provided flexible and specialist support to rare disease clinical trials and orphan disease clinical trials. Examples include: Duchenne Muscular Dystrophy (DMD), POMPE, Limb-Girdle Muscular Dystrophy and Systemic lupus erythematosus (SLE). 

Our flexible and adaptable systems allow us to deliver data tailored to your requirements for Phase I – IV, adult and pediatric trials. We work closely with KOLs who can support your protocol development.

 

 

Internationally renowned Over-readers ensure high-quality data and feedback for your trial, which improves site data, compliance, and performance.

A highly qualified and responsive team of project and data managers will be dedicated to your study, allowing for informed decisions to be made quickly and for prompt response and feedback to any queries. It also ensures key milestones and timelines are met.

We assure the rapid delivery of your rare or orphan disease clinical trial.

Objectives & Endpoints

Accurate, reliable and precise capture of PFT data for rare and orphan disease clinical trials.

 

Criteria Example Endpoints
Subjective Endpoints
  • Symptom scores
  • Study medication use
  • eCOA and questionnaires can be integrated to meet study needs
Objective Endpoints
  • In clinic Lung Function Testing:
    • PEF
    • VC
    • FVC
    • FVC% Predicted
    • FEV1
    • FEV1% Predicted
  • Sitting and Supine Spirometry
  • Respiratory Muscle Testing: MEP, MIP, SNIP, PCF, IFR
  • Home monitoring FEV1 & PEF
  • 6MWD

Resources

References

Visit our library of spirometry, respiratory and cough-related articles.

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Case Studies

Learn more about our experience.

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White Papers

View white papers prepared and researched by our in-house experts.

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Contact Us

Speak to our team about our experience and how our services can benefit your study.

Contact us

Vitalograph is a global leader in respiratory diagnostics. We produce high quality, accurate and reliable, respiratory medical devices & services for primary, secondary healthcare and occupational health. We deliver successful clinical trials for leading pharmaceutical companies, biotechs and research organizations.

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Vitalograph Inc
13310 W. 99th St.
Lenexa, KS 66215
United States

E: clinical.trials@vitalograph.com

Toll Free: 1-800-255-6626

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