Our Numbers Speak for Themselves
In the past five years alone we have completed over 150 Class II and III medical device trials, involving 5,000+ patients and 300+ sites. CROMSOURCE has 550+ staff strategically located across Europe and North America and is proud of our 90% repeat business rate.
Our specialist medical device staff has well over 200+ years of combined medical device clinical research experience. From simple pilot studies to large, complex trials across multiple countries, from pre-market to post-market, you can rely on our expertise.
CROMSOURCE delivers whatever support you need with milestones that are guaranteed.
Broad Therapeutic Experience
CROMSOURCE has successfully conducted studies in a wide-range of therapeutic areas. Our CRAB and Project Managers are assigned to your project based on their experience in your specific therapeutic area, ensuring a fast study start-up and a higher-quality study outcome.
Clinical Experience in areas including, but not limited to:
- Drug Delivery
- Combination Products
- In-Vitro Diagnostics
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 Pls in those countries, facilitating study start up and data quality.
We offer medical device sponsors the following services:
- Feasibility Studies and Study Design Regulatory Strategy and Negotiation
- Data Management and Biostatistics
- Quality Assurance and Quality Programs CMMedical Writing
- Regulatory Documentation and Submission
- Third Party Vendor Management
- Site Selection
- Site Monitoring
- Safety and Materiovigilance
- Project Management
- Device Management
- Legal Counsel
- Information Technology
Office Locations: USA, Belgium, France, Germany, Italy, Netherlands, Poland, Russia, Spain, UK, Ukraine
CROMSOURCE is the only CRO to offer sponsors a performance guarantee. We will start and complete the study on-time, enroll the agreed number of patients, and do it for the price originally agreed upon. And we'll put that promise in writing with penalties that mean something.
So when your medical device study requires a team of clinical operations professionals with specialist experience in medical devices, think CROMSOURCE
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
Via Giorgio De Sandre, 3 37135 Verona - Italy
Direct: +39 045 8222811
Fax: +39 045 8222812
ISO 9001:2008 multi-site certified quality management system
ISO 14155:2011 conformity confirmed