Strategic Clinical Oversight for Global Respiratory Research

UK Hospitals

Hospital Staff Relationships

Years of Experience

While our team played a significant role in the urgent delivery of COVID-19 research throughout the pandemic, our respiratory expertise extends far beyond a single indication. We operate as a specialist, global CRO based in the UK, providing both phase-specific support and comprehensive end-to-end management for trials across the full respiratory spectrum.

We partner with biotech and pharmaceutical firms to deliver studies that are scientifically robust and operationally viable in high-pressure clinical environments.

Navigating the Nuances of Respiratory Studies

Respiratory research is increasingly focused on precision medicine, biological therapies, and novel delivery systems.

These trials require more than just standard monitoring; they demand a team that understands the technicalities of lung function testing, such as spirometry and FeNO measurements, alongside the complexities of aerosol science.

We design study frameworks that account for the seasonal nature of respiratory conditions and the specific safety requirements of inhaled or nebulised therapies.

Expert Site Selection and Clinical Intelligence

Finding the right environment for a respiratory trial requires a deep understanding of site-level capacity and local patient demographics.

Through our experience with UK and European sites, we identify the specialist clinics and tertiary centres that have the dedicated pulmonary function labs needed for high-quality data.

Our advantage comes from years of direct collaboration. We know which sites can navigate the rapid set-up needed for acute respiratory studies and which units have the strongest recruitment track records in chronic conditions like COPD or asthma.

By working with us, you gain access to this local intelligence, ensuring your trial is placed at sites that are technically equipped and operationally ready, avoiding the delays often associated with more saturated or less specialised units.

Coordinating Complex Diagnostics and Logistics

The success of respiratory trials is predicated on the consistency of their diagnostic data. We specialise in synchronising high-intensity requirements, including central reading for chest imaging, standardised lung function equipment, and the collection of complex sputum or BAL samples.

We act as the vital link between the sponsor, the clinical site, and the laboratory, ensuring that every data point is captured with the precision required for global regulatory approval.

Frequently Asked Questions

What range of services do you provide for respiratory trials?

We offer a full-service model including protocol design, regulatory submissions, site selection, and monitoring. Our support covers a wide range of indications beyond COVID-19, including chronic obstructive pulmonary disease (COPD), asthma, cystic fibrosis, and idiopathic pulmonary fibrosis (IPF).

How do you help sponsors select the right European sites?

Because we know the UK and European sites so intimately, we guide sponsors toward locations that have the specific pulmonary function infrastructure required. We identify sites that have the capacity to recruit quickly and a proven track record in respiratory investigations.

Can you handle the regulatory hurdles for inhaled therapies?

Yes. Our team is well-versed in the specific regulatory requirements for inhaled medicinal products and delivery devices. We manage complex submissions to the MHRA and EMA, ensuring that all safety reporting and device performance monitoring meet international standards.

How do you manage seasonal challenges in respiratory recruitment?

We build seasonal variability into the trial timeline at the outset. By selecting a mix of global sites and using our local intelligence to time the recruitment window, we ensure that your study remains on track despite the predictable peaks in clinical service demand.

What makes your project teams different from a large, generic CRO?

Continuity and technical focus. In respiratory research, where understanding the nuances of lung function data is critical, having the same senior experts from planning through to close-out prevents data errors. You won’t deal with a revolving door of staff who don't understand your therapeutic area.

Do you support companies with early-phase and feasibility studies?

Absolutely. We have extensive experience with early-phase trials and "First-in-Human" studies for novel respiratory therapies. We provide the agile framework needed to gather early safety and efficacy data before moving into larger pivotal trials.

Case Study: Rapid Site Mobilisation for an Investigational Respiratory Treatment

As the full-service lead for the international study of a novel kinase inhibitor, we managed the accelerated deployment of the UK arm of a trial focusing on patients suffering from COVID-19 who were hospitalised with acute respiratory distress.

Given the time-sensitive nature of the clinical demand, the sponsor required immediate activation to capture data during a critical window of patient availability.

We leveraged our excellent contacts across the UK research infrastructure to select and activate six high-performing sites in record time.

By bypassing traditional administrative bottlenecks and working directly with the principal investigators and R&D offices we know so well, we achieved site set-up and "green light" status far faster than standard industry timelines.

This hands-on coordination ensured that the sites were operationally ready to begin enrolment immediately, providing the sponsor with a robust and timely data set for this high-priority therapeutic candidate.

“A very professional & experienced team, proactive & reactive as needed to face all clinical trial challenges and reach their clients’ goals successfully. We also appreciate their “human” side at work, especially in the sometimes stressful environment of the pharmaceutical world.”

RevImmune, Frederique Berbille
Director of Clinical Operations