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 enrollment.
CROMSOURCE has such deep experience in respiratory disease that we are able to advise clients on the design and implementation of their entire respiratory development plan. Due to our expertise we also support a large scientific, non-commercial project in severe adult and pediatric asthma funded jointly by the EU and several global pharmaceutical companies.
Respiratory Experts
CROMSOURCE's respiratory experience includes over 85 studies in thousands of patients, both in adult and pediatric populations, Phase Ithrough 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 infection, rhinosinusitis and chronic bronchitis.
Respiratory Experience
Indications with particularly deep experience include:
Respiratory trials also often require coordination of several third party vendors, such as central spirometry, ePRO and central laboratories. CROMSOURCE assumes responsibility forthe selection (where permitted), management and performance of these vendors. Furthermore, our Clin- Track® application assures that real-time data held on these various databases is available in one integrated web-based platform.
Primary Countries / Investigational Sites for Best results
CROMSOURCE has developed our unique Feasibility PlusTM approach which is provided without obligation at the RFP stage to potential clients. This stringent methodology is the foundation of our ability to deliver our "End-to-End Guarantee."
Working closely with our clients, CROMSOURCE identifies those geographic areas well known for their prevalence of the targeted indication. All regulatory requirements are then reviewed and ti meliness developed for each country to ensure fast regulatory approvals.
CROMSOURCE then works directly with the most professional and productive sites in each geography. Sites are only considered if they have proven they can deliver a combination of high enrollment, high retention, and quality data.
With the accurate and detailed trial planning data provided by Feasibility PlusTM CROMSOURCE can offer sponsors a comprehensive "End-to-End Guarantee," assuring them that their study will be completed on time and on budget with no CRO initiated changes in scope.
Why CROMSOURCE?
- Respiratory expertise & experience
- The only "End-to-End Guarantee" in the industry
- Operational excellence based on 20 years of experience
- Intimate Knowledge of Sites, Investigators, KOLs CROMSOURCE'S GUARANTEE
CROMSOURCE guarantees timelines for Study Start Up, Enrollment and Date for Database Lock. Moreover, we guarantee there will be no post-signature, CRO-initiated change orders.
The price agreed upon at contract signing will be the price you will pay.
Our End-to-End Guarantee
- Guaranteed study start-up time
- Guaranteed enrollment
- Guaranteed price with no CRO initiated changes in scope
- Guaranteed database lock date
How can CROMSOURCE do this?
- Realistic and deeply detailed feasibility analysis
- Operational excellence within a cohesive team
- Excellent, long-term relationships with sites, investigators, and KOLs
North American Headquarters
One Alewife Center, Suite 120 Cambridge, MA 02140 - USA
Direct: +1 617 871 1128
Fax: +1 617 871 1129
European Headquarters
Via Giorgio De Sandre, 3 37135 Verona - Italy
Direct: +39 045 8222811
Fax: +39 045 8222812
CROMSOURCE Quality
ISO 9001:2008 multi-site certified quality management system
ISO 14155:2011 conformity confirmed
Cloud Media Management
CROMSOURCE, via Techorizon (the CROMSOURCE IT branch) provides a service (GAMP 5 compliant) to support our clients in managing image acquisition, collection, centralized evaluation and archiving. Our Cloud Media Management tool providescentralized capabilities for managing any type of media, including magnetic resonance imaging and computed tomography.
Oriana Zerbini
Chief Executive Officer
Margherita Mosconi
Client Project Development Director
Margherita.Mosconi@cromsource.com
Antoinette Torres Frankum
Head of US Operations
Antoinette.TorresFrankum@cromsource.com