Medical Device Overview

Dedicated to Medical Devices Research

CROMSOURCE is highly qualified to assist you during all phases of product development, through the approval process with the FDA and the regulatory authorities, and with post-marketing requirements.

For over 25 years, CROMSOURCE has been helping clients conduct successful trials. We offer strategic regulatory consulting for medical device companies in multiple markets - from initial regulatory strategy, preparing and compiling submissions, to post-market commercialization.

Our Numbers Speak for Themselves

We have completed hundreds Class II and III medical device trials and have a repeat business rate of 90%. We pride ourselves on building great relationships with our clients through successful clinical trials.

Our specialist medical device staff has decades of combined medical device clinical research experience. You can rely on our expertise in areas from simple pilot studies to large, complex trials across multiple countries and for your pre- and post-market needs.

CROMSOURCE delivers the 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 experienced Project Managers and CRA’s 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.

Our Expertise Ensures Your Success

CROMSOURCE has developed a stringent methodology to help sponsors identify the highest enroling countries and sites during the feasibility stage. Our unique Feasibility PlusTM approach is provided to potential clients without obligation at the RFP stage and is the foundation of our ability to offer sponsors a guaranteed timeline, enrolment and budget.

Working closely with our clients, CROMSOURCE identifies 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 best regulatory strategy.

CROMSOURCE works directly with the most successful sites in recruiting patients. Sites are only considered if they have proven they can deliver a combination of high enrolment, high retention and quality data.

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 high-quality data.

We offer our clients the following services:

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

Why CROMSOURCE

• Medical Device Expertise and Experience
• Operational Excellence Based on More Than 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 14155:2020
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

Medical Device Overview