Transform IVD Performance with a Hybrid Monitoring Approach
About this webinar
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.
Who should attend
- Clinical Affairs Managers and Directors
- Clinical Trial and Study Managers
- Clinical Operations professionals
- Regulatory Affairs Specialists and Managers
- Quality Assurance professionals
- Medical Affairs professionals
- R&D and Product Development leaders
- Laboratory Managers supporting clinical performance studies
- IVD Manufacturers, Diagnostic Developers and biotech organisations seeking to strengthen study oversight and regulatory compliance
What you will learn
- Understand how a hybrid monitoring approach strengthens oversight, quality and regulatory compliance in IVD clinical studies
- Discover how sponsor delegation service provides experienced clinical and regulatory leadership while allowing sponsors to retain overall study responsibility
- Learn practical strategies for improving study coordination, reducing operational risk and enhancing communication across sites, vendors and stakeholders.
- Explore how integrated clinical, regulatory and quality expertise can support more efficient study execution and successful regulatory submissions
Featured Speakers
Jessica Green
Jessica Green is a Biomedical Scientist with over five years of experience working across regulated diagnostic and medical device environments. Her expertise spans immunoassay research and development, product transfer and quality management, giving her a strong understanding of both the scientific and regulatory requirements involved in bringing diagnostic products through development.
She has experience working with ISO 13485 quality management systems, IVDR technical documentation and global regulatory requirements and submissions. Combining a strong scientific background with practical experience of regulated product development, Jessica brings valuable insight into navigating the regulatory and operational complexities of IVD clinical studies.
Andrew Mercier
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.
Partner for this event
ARC Regulatory
Based in Northern Ireland, ARC is a Clinical Research Organisation focused on delivering compliance excellence within the precision medicine sector. The company supports leading pharmaceutical R&D organisations by enabling the use of unapproved diagnostics in clinical development programmes for patient selection and stratification. Acting as a strategic partner, ARC assumes full sponsor responsibility for IVD studies conducted alongside IND/IMP trials.
ARC’s purpose is to accelerate global patient access to precision medicine clinical trials. This is achieved through a highly experienced team with deep domain expertise and strong partnerships with leading international clients. Its multidisciplinary team spans regulatory compliance, study design, approvals, quality assurance, and vendor management, alongside clinical research specialists who ensure studies meet global and local GCP standards and produce reliable biomarker data.
To further enhance its offering, ARC’s clinical trial enablement platform, ARC360 streamlines regulatory intelligence and accelerates the setup of complex clinical trials involving in vitro diagnostics.
