Clinical Trial Solutions

We develop innovative clinical trial solutions that generate more reliable data across diverse patient populations

Our mission is to deepen understanding of lung health so better decisions can be made in the care of people with respiratory conditions and in the development of therapies that improve their quality of life.

Respiratory Expertise Faculty

Data Management

Vitalograph delivers clinical trial data management services that provide timely, actionable respiratory data insights and support confidence in data quality, accuracy, and study oversight.

The service supports the full data lifecycle, including data capture, processing, monitoring, and interpretation from integrated respiratory devices and connected clinical trial systems.

It provides interactive dashboards, standard and custom reports, datasets, and APIs to enable real-time visibility of study status, subject progression, visit tracking, and respiratory outcomes, with full drill-down capability.

Integration with Sponsor, CRO, eCRF, and EDC systems supports efficient data reconciliation, synchronisation, and centralised study oversight across platforms.

The Electronic Data Correction Facility (eDCF) 360 platform enables site-level data corrections, reducing site burden while improving data integrity and operational efficiency across the study lifecycle.

Project Management

Vitalograph provides clinical trial project management services designed to ensure effective study delivery, operational alignment, and sponsor confidence in execution.

Each study is supported by a dedicated respiratory-focused project team, including Project Managers, Senior Project Managers, Respiratory Physiologists, and Project Directors, ensuring continuity and protocol expertise throughout the study lifecycle.

A structured governance framework is implemented for all studies, supporting risk management, issue resolution, and performance oversight, with regular governance meetings led by the Project Director.

Project Managers act as the primary operational interface for sponsors and sites, coordinating cross-functional activities, managing timelines, and ensuring efficient resolution of operational issues.

Communication is flexible and adapted to sponsor and regional requirements, including local communication channels where appropriate to support efficient study delivery.

The project team maintains end-to-end ownership of study execution, ensuring alignment with timelines, quality requirements, and protocol objectives from study initiation through to close-out.

Overreading

Vitalograph provides sponsors with confidence in data quality by acting as an extension of the medical monitor team, supported by a dedicated Respiratory Physiologist for each study.

A global in-house team of respiratory experts performs over-reading of all pulmonary function test (PFT) data in line with ATS/ERS guidelines, ensuring consistent interpretation across global clinical trials.

Services include study design consultation, active respiratory data monitoring, and early identification of data anomalies or deviations to support timely corrective action and improved study outcomes.

Over-reading ensures consistent test quality and protocol adherence, with flexible turnaround times from standard review to 1+ hour for urgent clinical trial requirements.

Respiratory data quality reports support medical monitor teams with structured insights for ongoing study oversight and decision-making.

Training

High-quality clinical trial data starts with effective respiratory site training. Vitalograph delivers customised clinical trial training solutions designed to improve data quality, reduce site burden, and enhance patient experience.

Training is based on a Learning Needs Analysis (LNA) aligned to protocol requirements, site roles, and patient population needs. A premium site activation model enables equipment installation and technician certification in a single visit where applicable.

Training programmes include technician certification, investigator meetings (in-person and virtual), eLearning modules, system training, and refresher training for long-term studies.

Ongoing in-study performance monitoring identifies training gaps early, enabling targeted re-training and continuous improvement in respiratory data quality and protocol compliance.

Site Support & Logistics

Vitalograph provides clinical trial site support and logistics services to ensure efficient site activation, equipment delivery, and smooth patient-level delivery.

A 100% respiratory-focused global support team delivers end-to-end assistance to sites and CRAs via a local-language helpdesk, supported by an automated knowledge base for rapid issue resolution. Flexible communication channels, including regional tools such as WeChat, support global study efficiency.

All PFT devices are manufactured, quality controlled, and exported from Ireland, ensuring consistent regulatory compliance, device quality, and global supply chain control. A dedicated logistics function manages shipping, customs, and clinical trial documentation, supported by in-country expertise where required.

A Premium Site Activation Service helps reduce start-up delays by identifying and resolving activation blockers, ensuring sites are fully equipped and operational in line with study timelines and complexity.

Consultation

Vitalograph clients have access to a faculty of respiratory experts and Key Opinion Leaders (KOLs) providing specialist insight across clinical trial design and execution.

Support spans protocol development through to data interpretation and analysis, helping optimise study design and respiratory endpoints.

The Vitalograph faculty acts as a trusted advisory resource for sponsors, available to consult on key protocol and study considerations throughout the trial lifecycle.