Dedicated to Research of Medical Devices
CROMSOURCE is highly qualified to assist you during all phases of product development, through the approval process with FDA and the regulatory authorities, and with post-marketing requirements.
We offer Strategic Regulatory Consulting for medical device companies in multiple markets - from initial regulatory strategy, preparing and compiling submissions, and to post-market commercialization.
Our Numbers Speak for Themselves
In the past five years alone we have completed over 150 Class II and III medical device trials, involving more than 41,000 patients and more than 2,800 sites. CROMSOURCE has approximately 500 staff strategically located across Europe and North America and is proud of our 90% repeat business.
Our specialist medical device staff has decades 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 experience with medical devices across many classes spanning a diverse range of therapeutic areas and indications.
Our Project Managers and CRA’s have medical device experience and 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.
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 selected. We have strong relationships with regulators, sites, and Pls in those countries, facilitating study start-up and high-quality data.
- Project Management
- Global Clinical Operations
- Regulatory Affairs
- Safety Services
- Medical Affairs
- Medical Writing
- Flexible Resourcing Solutions
THE CROMSOURCE ADVANTAGE
- Big enough to perform large, global trials, yet small enough to offer the flexibility and attention to customer focus
- 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.
When your medical device study requires a team with expertise in medical devices, think CROMSOURCE.
ISO 9001:2015 multi-site
Via Giorgio De Sandre, 3
37135 Verona - Italy
Direct: +39 045 8222811
North American Headquarters
309 Waverley Oaks Road, Suite 101
Waltham, MA 02452 - USA
Direct: +1 617.871.1128
CROMSOURCE is an international provider of outsourced services to the Medical Device, Pharmaceutical and Biotechnology industries, specialized in clinical development and staffing solutions.Medical Device Overview
|2019 CROMSOURCE Medical Device Overview.pdf||Download|