Partnering to provide vital regional support on a global medical device study

A medical device company conducted a study with sites in ten countries including 58 sites in the US, 17 in Europe and 4 in Asia. Participant enrolment began in 2017 with over 1,000 participants enrolled by completion in 2019. Randomised participants with stenotic lesions of the femoropopliteal artery, were treated with one of two drug coated balloon devices depending on whether they were in the control or treatment group. Participants were followed for 60 months. 

The study sponsor contracted a US contract research organisation (CRO) as the primary CRO with overall study oversight. However, the primary CRO was unable to provide all required services inhouse and contracted regional CROs to manage regulatory, start up and monitoring activities locally. ICON was selected as a European partner CRO, supporting regulatory services, study start up and monitoring activities, and safety reporting service for study sites in Austria, Belgium, Czech Republic, Germany and Latvia. 

The primary CRO’s key challenge was ensuring that their partner CROs operated in accordance with: 

• Device regulatory practices
• Country regulations
• Primary CRO standard operating procedures (SOPs)
• Subcontracted CRO and study specific procedures
• Study protocol and operational plans
• Master agreement and contractual agreements with primary CRO

As part of the vendor selection process the primary CRO conducted vendor qualification audits to verify that the intended services would conform to client requirements. Once selected, a detailed oversight plan was implemented to clearly define responsibilities. Periodic assessments of the partner CROs’ performances and adherence to contractual requirements were conducted. ICON contributed during the planning stage and throughout the study to align with the process requirements.

The study was completed successfully with the final study report issued in December 2024. The sponsor’s drug-coated balloon device received CE Mark certification in June 2020 and FDA approval in June 2023. During the study ICON SOPs and processes were followed in conjunction with the existing primary and other vendor SOPs. The sponsor and CRO were highly satisfied with the close collaboration from ICON project managers, study start up associates and clinical research associates.