ALS Respiratory Clinical Trial Services

At Vitalograph we provide specialised respiratory assessment solutions for Amyotrophic Lateral Sclerosis (ALS) and Motor Neuron Disease (MND) clinical trials

What Vitalograph Offer

Our expertise, reliable data collection, and committed support at every stage of your study ensure successful outcomes and accurate insights into disease progression.

We support all phases of ALS and MND research and tailor our services to meet the unique needs of each study. Whether it’s precise respiratory measurements, expert over-reading, training support, or eCOA integration, we are committed to helping you achieve your clinical trial objectives.

Download: 8 Essential Factors for ALS Clinical Trials

Our Services

Clinical Trial Management Services

We provide two dedicated members of our project management team for every study, including one Project Manager to ensure your trial runs smoothly and on schedule.
Our in-house site support team are the first contact for your site staff and CRAs. They aim to ease site burden and enable site staff to get the best quality data.
Our Training Manager works closely with your team to design training tailored to the study design, protocol, and staff experience from inception through to completion of the clinical trial.
Benefit from continuous access to subject matter experts, regardless of study size or phase ensuring informed decisions at every stage.

Data Services

Receive detailed, real-time data monitoring and analysis tailored specifically to your study requirements.
Utilize our industry-leading, in-house manufactured devices and software, designed specifically for clinical trials to ensure data precision.
Our eCOA solutions streamline data collection, reducing site and sponsor burden.
A specialist team of respiratory physiologists provide over-reading services to ensure compliance with ATS/ERS guidelines, ensuring data integrity and accuracy at every step.

Key Endpoints We Measure

The ALSFRS-R survey, SVC, SNIP and heart rate are the most common measurements we use in ALS studies. Relevant measurements include:

ALSFRS-R (ALS Functional Rating Scale – Revised): The ALSFRS-R survey is the primary endpoint for ALS studies. We support this through our eCOA services.
Forced vital capacity (FVC): A primary endpoint in ALS studies, FVC is critical for tracking respiratory function over the course of treatment and disease progression.
Slow vital capacity (SVC): An important secondary endpoint, monitoring SVC helps assess lung function decline in ALS patients and the effectiveness of therapeutic interventions.
Forced expiratory volume (FEV1): This measure is crucial for monitoring lung health, particularly in ALS patients with compromised respiratory function.
Sniff nasal inspiratory pressure (SNIP): This test is used to assess inspiratory muscle strength, helping evaluate the effectiveness of ALS treatments.
Heart rate: We use the ECG to monitor any cardiac changes that may be associated with ALS, particularly as the disease progresses.

We use the COMPACT to centralise this data. By combining objective respiratory data with patient-reported outcomes, we provide a comprehensive view of a subject’s health, enabling better-informed decision-making throughout the trial.

Criteria

Endpoints

Subjective Endpoints