Monitoring

The excellence

Cardinal Systems started to propose On-site Monitoring in 1999 with its first full services’ study. With state-of-the-art gold standards and multi-areas’ experiences, Cardinal Systems monitoring team can respond to all needs like Regulatory Submission, Source Document Verification and Motivational site visit.

The Cardinal Systems monitoring team performance in Study Start-up has already highlighted the importance of assigning monitoring experts at that stage of the study. Cardinal Systems proposes Feasibility services in order to provide its clients with more visibility on key parameters in study success.

The flexibility

Cardinal Systems has developed its peri- and post- AMM expertise since 2000. These studies required additional strengths developed by Cardinal Systems through its e-Monitoring group:

• A Call Center able to respond to Investigators in ALL countries
• A synchronized approach to perform the monitoring remotely
• A team well-trained on Observational studies, Registries and Expended Access Programs (French ATU)
• A Marketing approach with innovative, customized and cost effective solutions in product awareness’ study

Cardinal Systems entails qualitative Strategic Alliances with proven partners in order to broaden its capabilities. Thanks to its Re-sourcing department, Cardinal Systems has already a pond of experienced Clinical Research Associates and Project Managers ready to handle new projects. This bridge reinforces Cardinal Systems flexibility and enlarges employees’ perspectives of personal development.

The Technology

Cardinal Systems provides Information Technology support for optimizing Protocol availability and Clinical Report Form (CRF) completion and for Reporting monitoring activities.

With Cardinal Systems’ proprietary software InfoGate® you can:

• Develop your eCRF
• Increase your visibility on study progression with an user-friendly Clinical Trial Management System (CTMS)
• Allow the share of information among all actors of your project (project team, investigators, providers, vendors…)
• Streamline the Reporting of project activities

Cardinal Systems has developed a proven IxRS solution, which is entirely integrated to Monitoring/eMonitoring groups.

Project Management

Cardinal Systems believes that effective Project Management is a key factor of success in the conduct of clinical trials. Cardinal Systems Project Managers guide the teamwork efficiently through the different services required on a project – Medical Writing, Data Management, Statistics, Monitoring groups and/or other interfaces like DSMB or Expert panels.

This process necessitates extensive knowledge in clinical drug development. Therefore, Cardinal Systems has put in place qualitative and attractive recruitment process.

Cardinal Systems Project Managers ensure the compliance with the Project plan, the Communication plan and the Standard or Specific procedures within the budget and timelines.

Thanks to its size, Cardinal Systems can involve its Project Managers very early in the strategic discussion stage to benefice from their experience. At Cardinal Systems, the Project Manager is the privileged interface with our Clients’ representatives.

Cardinal Systems can offer International Project Management services from Europe and North America.