Clinical Trial Services

Vitalograph offers expert support for clinical trials with top-tier data management, project oversight, and clinical services worldwide. Our tailored solutions ensure efficiency, high-quality data, and seamless integration with your trial needs.

Data Management

Our clinical trial data services support the collection, quality, and availability of centralized study data from our integrated devices and data sources. Datasets are flexible and configurable to sponsor-defined fields, with recommendations tailored to protocol and study requirements.

Standard and custom reports and dashboards support study functions, including clinical alerts and outcomes, subject and visit status, and training monitoring. Our data API provides ready-to-use integrations with sponsor, CRO, and eCRF systems, which coupled with our reports and dashboards enhance real-time data monitoring and visibility for all users.

Routine data monitoring is performed throughout the study using standardised dashboards, reports, and queries. Where supported, our Electronic Data Correction Facility (eDCF) 360 platform enables data corrections to be made directly by the site user, helping reduce site burden.

Findings are communicated to Sponsors, CROs, or sites to address data quality issues, support retraining, and resolve equipment or data capture concerns, with flexible dataset delivery available before, during, and after the study.

Your data is our priority.

Project Management

Our Project Managers liaise with all Vitalograph functions and coordinate all aspects of Vitalograph support for your study.

Each study is supported by our Project Director, a Senior Project Manager, and Project Managers to monitor risks, resolve issues, and align delivery with your objectives.

We provide established governance plans to all clients, designed to leverage the expertise of both organisations and improve service delivery, quality, and cost efficiency. Regular governance meetings are hosted by the Project Director. Our Project Managers are the face of Vitalograph, consistently praised by sponsor study teams for their dedication to study success

We take ownership and deliver results.

Clinical Services and Over-reading

Vitalograph provides expert over-reading (quality control) services for lung function, ECG, and cough data. All pulmonary function test (PFT) data is over-read by an in-house team of Respiratory Physiologists in accordance with the latest ATS/ERS guidelines.

Each study is supported by a dedicated Respiratory Physiologist who works closely with the Vitalograph Project Manager, sponsor, and CRO to provide subject matter expertise throughout the study. In addition to over-reading, our experts support protocol review, software configuration, study-specific training, and investigator liaison as required.

We offer flexible turnaround times to meet study timelines and budgets. While our standard turnaround time is two business days, expedited reviews are available for critical visits.

Data you can rely on.

Training

High-quality data starts with effective training. Vitalograph delivers fully tailored clinical trial training solutions based on your protocol and a Learning Needs Assessment conducted prior to the start of each study. Training is designed to support site staff, study teams, and investigators throughout the trial lifecycle.

Our training services include hands-on system training, study-specific eLearning with certification, live web-based sessions, refresher training for long-term studies, and on-site or one-to-one coaching. Training can be delivered as part of Site Initiation Visits, to include equipment setup, or at Investigator Meetings. Vitalograph typically hosts Vendor Booths at Investigator Meetings where attendees can engage with the Vitalograph team and equipment on a 1:1 basis away from the main group.

Training effectiveness is supported through competency assessments, ongoing in-study data monitoring, and clinical over-reading. An agreed escalation process is established with the Sponsor and CRO (where applicable) to identify site staff who may benefit from additional one-to-one training before or during patient testing. Over-reading insights and key training metrics are continuously reviewed, with any training-related concerns raised during regular project team meetings to ensure timely intervention and sustained data quality throughout the study.

Comprehensive training, quality data.

Site Support & Logistics

Our in-house Site Support team is available to assist site staff and CRAs throughout the study. The team is trained on each study-specific system and manages queries end-to-end, with prompt follow-up where issues require further investigation. Monitoring of call trends allows potential risks to be identified early and escalated to sponsors before they impact study delivery.

All PFT equipment is manufactured, quality checked, and exported from Vitalograph facilities in Ireland, giving us full control over production quality, regulatory compliance, and global supply. Our in-house manufacturing model enables fast response times, flexibility for country-specific requirements, and consistent device standards across global trials. We have a dedicated export team and work with a network of trusted logistics partners and can support Importer of Record (IoR) documentation to ensure smooth and timely delivery to sites.

To further support study timelines, Vitalograph offers a Premium Site Activation Service that complements sponsor and CRO site readiness activities. This scalable, tiered service helps identify and resolve activation blockers, supports transparent shipping processes, and ensures sites are equipped and operational on schedule, aligned to the complexity and needs of your study.

We find solutions.