In pharma sponsored In Vitro Diagnostic (IVD) and CDx  clinical studies within precision medicine IND/IMP trials, sponsors must navigate a complex journey through the IVD product development cycle. From study planning and regulatory submissions to final database lock, the sponsor plays a vital role in guiding the study from concept to completion.  

ARC’s Pharma Sponsored IVD/CDx Clinical Studies Roadmap outlines the key responsibilities and involvement areas for sponsors of IVD/CDx clinical studies in a graphic and simple manner and offers a clear and comprehensive path through each phase of the study lifecycle. The sponsor oversees the successful execution of each phase while adhering to industry standards and regulatory requirements to achieve successful study outcomes.  

ARC is here to help Sponsors succeed on their IVD/CDx Clinical study journey. Please contact us with any questions and, if you decide to delegate your IVD/CDx clinical study sponsor responsibilities to ARC, we will act as an extension to your pharma clinical teams, seamlessly integrating with your processes to keep your Precision Medicine Clinical Trials compliant and efficient.  You can "plug” into our Quality Management System and allow the ARC team to conduct your IVD/CDx clinical study, from study design, site management, and regulatory submissions through to data analysis and report generation, all while ensuring the rights, safety and wellbeing of patients is upheld and data is robust.