Respiratory Overview

Dedicated to Respiratory Research

Successful completion of clinical trials in respiratory disease often requires a particular understanding of the disease and the impact of certain inclusion criteria (such as PEF reversibility) on enrolment.

For nearly twenty-five years, CROMSOURCE has performed hundreds of trials focused on respiratory disease. We are able to advise clients on the design and implementation of the entire respiratory development plan.

Respiratory Expert

CROMSOURCE’s respiratory experience includes hundreds of studies in thousands of patients, both in adult and paediatric populations, Phase I through Registry.

We have completed studies in a wide range of conditions including, but not limited to, asthma, COPD, cystic fibrosis, lower respiratory tract infections, lung cancer, smoking cessation, upper respiratory tract infections, rhino sinusitis, and chronic bronchitis.

Respiratory Experience

Respiratory trials often require coordination of many third party vendors, such as central spirometry, ePRO, and central laboratories. CROMSOURCE, in collaboration with the client, assumes responsibility for selection and oversight of these vendors.

Our Expertise Ensures Your Success

CROMSOURCE has developed a comprehensive and well-defined methodology to identify the highest enrolling countries and sites during the feasibility stage. Our unique Feasibility PlusTM approach is provided to potential clients without obligation at the proposal stage and is the foundation of our ability to offer clients a guaranteed timeline, enrolment rate and budget.

Working closely with our clients, CROMSOURCE identifies those geographic areas well-known for their prevalence of the targeted indication. All regulatory requirements are reviewed and timelines are developed for each country to ensure the optimum regulatory strategy. CROMSOURCE then works directly with the most successful sites in each area. Sites are only considered if they have proven they can deliver a combination of high enrolment, high retention, and quality data.

With the accurate and detailed trial planning data provided by Feasibility PlusTM, CROMSOURCE confidently offers clients a comprehensive “End-to-End Guarantee”, assuring them that their study will be completed on-time and within-budget without CRO-initiated changes in scope.

All the Services You Need, Where You Need Them

With offices throughout the US and Europe, CROMSOURCE deploys the resources you need in the countries you select. We have strong relationships with regulators, sites, and principal investigators in those countries, facilitating study start up and data quality.

We offer our clients the following services:

• Feasibility
• Project Management
• Clinical Operations
• Biometrics
• Regulatory Affairs
• Safety
• Medical Affairs
• Medical Writing
• Flexible Resourcing Solutions

Why CROMSOURCE

• Respiratory Expertise and Experience
• Operational Excellence Based on Nearly 25 Years of Experience
• The Only “End-to-End Guarantee” in the Industry
• Detailed Knowledge of Sites, Investigators, KOLs

Performance Guaranteed

CROMSOURCE is the only CRO to offer clients a performance guarantee.
We will start and complete the study on-time, enrol the agreed number of patients, and do it for the price originally agreed upon.

The CROMSOURCE Advantage

• Consistent quality systems across the entire business
• Executive oversight that provides the highest level of attention
• Consistent on-time, on-budget project delivery
• Low employee turnover resulting in consistency and continuity across the program
• Global Presence. Local Expertise.
• Big enough to perform large, global trials, yet small enough to offer the flexibility and
  attention to customer focus

Our End-to-End Guarantee

• Guaranteed study start-up time
• Guaranteed enrolment
• Guaranteed price without CRO-initiated changes in scope
• Guaranteed database lock date

How can CROMSOURCE do this?

• Realistic and highly detailed feasibility analysis
• Operational excellence within a cohesive team

CROMSOURCE Quality
ISO 9001:2015
multi-site certified quality
management system.
ISO 14155:2011
conformity confirmed.

European Headquarters:
Via Giorgio De Sandre, 3
37135 Verona - Italy
Direct: +39 045 8222811

North American Headquarters:
8000 Regency Parkway, Suite 575,
Cary, NC 27518 – USA
Direct: +1 919 626 9882

Email: cromsource@cromsource.com

Respiratory Overview