Clinical Trial Responsibility and Accountability Framework for Pharma Sponsored IVD/CDx Studies

To support Pharma Sponsors undertaking Precision Medicine Clinical Trials, ARC has developed a RACI (Responsible, Accountable, Consulted, Informed) matrix to help define the key Sponsor activities for Pharma Sponsored IVD/CDx Clinical Studies. The Clinical Trial Responsibility and Accountability Framework clearly describes study tasks and responsibilities that can be attributed to the device manufacturer, the testing laboratory, or the pharma sponsor. It will also help to identify areas which can be delegated to ARC as part of our Sponsor Delegation service.

Fill the form below to receive the Clinical Trial Responsibility and Accountability Framework , it will help ensure that all of the main aspects of the Pharma Sponsored IVD/CDx clinical studies have been identified and have clearly defined responsibilities. It will also aid to identify delegation gaps, where roles and responsibilities may be unclear or not adequately covered, potentially impacting the study's execution. 

Pharma Sponsors implementing IVD and CDx devices in their Precision Medicine Clinical Trials face multiple challenges, such as a shifting regulatory landscape, increased responsibility for the device, lack of IVD/CDx expertise and lack of adequate resource. ARC's IVD/CDx Clinical Study Sponsor Delegation Service helps to address these challenges and speeds up the successful completion of Pharma Sponsored IVD/CDx clinical studies. “Plug” into our Quality Management System and allow the ARC team to conduct your IVD/CDx clinical study, from study design, testing site management and regulatory submissions through to study close-out and report generation, all while ensuring the rights, safety and wellbeing of patients is upheld and data is robust.