Transform Clinical Performance with a Hybrid Monitoring Approach

Clinical performance studies for in vitro diagnostics (IVDs) are becoming increasingly complex, with sponsors expected to balance regulatory compliance, study oversight, data quality and operational efficiency while continuing to drive product innovation. Successfully managing these competing priorities requires more than effective project management; it demands a coordinated approach that combines clinical, regulatory and quality expertise.

This webinar explores how sponsor delegation service supports a hybrid monitoring approach. This approach can help sponsors strengthen oversight, improve study performance and reduce operational burden throughout the lifecycle of an IVD clinical study.

Attendees will learn how sponsor delegation enables sponsors to access experienced clinical and regulatory leadership while retaining overall responsibility for their studies. Acting as an extension of the sponsor’s team, delegated clinical and regulatory specialists can provide day-to-day coordination, governance and oversight, working alongside study sites, vendors and Clinical Research Associates (CRAs) to ensure activities remain aligned with regulatory expectations, study timelines and quality objectives.

The session will also examine the value of combining centralised oversight with balanced on-site monitoring to create a more agile and risk-based monitoring strategy. This hybrid approach provides greater visibility across study activities, supports proactive risk identification, enhances communication between stakeholders and enables faster decision-making when challenges arise.

Drawing on practical experience supporting diagnostic studies, the webinar will highlight how integrating clinical operations, regulatory expertise and quality management within a single study partner can improve consistency, minimise duplication of effort and help generate robust clinical evidence that supports successful regulatory submissions.

Whether an organisation has limited internal resources or is looking to optimise existing study management processes, sponsor delegation offers a flexible, scalable solution tailored to the needs of each study. By reducing operational complexity and strengthening governance, sponsors can remain focused on innovation and bringing new diagnostic technologies to market with greater confidence.

Register for this webinar to learn how hybrid monitoring can improve IVD study execution, strengthen oversight and reduce operational and regulatory risk.

Speakers

Dr. Ciara Devlin, Research Operations Lead, ARC Regulatory

Dr. Ciara Devlin has a strong scientific background spanning clinical research, diagnostics and regulated laboratory environments. Her PhD research explored the impact of GLP-1 agonist therapy on cognitive function, anxiety and depression in individuals with type 2 diabetes, alongside the investigation of biomarkers associated with treatment response. With experience in assay development, clinical diagnostics and quality-regulated environments, Ciara has developed expertise in laboratory testing, data analysis, regulatory compliance and project delivery. She has a strong understanding of ISO 15189 and GMP requirements and is experienced in managing projects, developing technical documentation and supporting the delivery of high-quality diagnostic products. In her current role as Research Operations Lead at ARC Regulatory, Ciara combines her scientific expertise with strong project management skills to support clinical studies and help clients navigate global in vitro diagnostic (IVD) regulatory requirements.

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Andrew Mercier, Alliance Manager, ARC Regulatory

Andrew is a former HCPC Registered Biomedical Scientist with over 12 years of clinical laboratory experience in the UK and Australia. He specialises in the validation and deployment of IVDs in the detection and monitoring of haematological and haemostatic disorders and providing site-level scientific support for clinical trials.

An accomplished Scientific Project Manager, he has extensive experience in precision medicine, clinical diagnostics and the delivery of scientific support for global clinical trials. His expertise spans next-generation sequencing (NGS) assay development, biomarker discovery and the application of a broad range of genomics platforms. He has a proven track record of leading multidisciplinary teams supporting global clinical trials within CLIA and CAP-accredited laboratories, as well as managing large regional laboratory operations. Andrew has extensive experience ensuring laboratory staff, processes and quality systems comply with ISO 15189 and GMP standards. Andrew has supported clinical trials across a range of therapeutic areas, including oncology, hepatology, haematology and pulmonary diseases, combining strong scientific expertise with effective project and operational leadership.

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