Sponsor Delegation for IVD Clinical Trials
Bring regulatory, clinical operations and study management activities together under one coordinated package. Our Sponsor Delegation model helps reduce risk, improve oversight and keep complex IVD clinical trials moving with confidence
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Client Problem
Delegating trial responsibilities is often essential—but it introduces complexity. Sponsors remain fully accountable, yet must rely on multiple external partners, systems, and sites to execute critical activities. ARC's Sponsor Delegation package can reduce the complexity of performing global IVD studies by performing key study activities with autonomy, transparency and always with sponsor oversight.
ARC brings industry expertise to manage ethics and regulatory submissions with confidence across global studies.
Ensure laboratories are qualified, compliant, and ready to support your trial. Our industry experts ensure your diagnostic partners are compliant to global standards including ISO15189 and ISO20916.
Independent oversight of diagnostic laboratories to maintain quality, compliance, and performance standards are met and maintained throughout the course of your study.
Development and maintenance of essential study documents, including CSPs, IBs and monitoring plans, in line with applicable regulatory requirements.
Timely reporting and ongoing support for regulatory safety obligations.
Coordinated oversight of timelines, budgets, deliverables, and stakeholders.
What is Sponsor Delegation?
Sponsor Delegation combines these workstreams into a coordinated delivery model, providing a single framework for managing the device study throughout the trial lifecycle.
One Delivery Team
Reduce handovers and communication gaps.
One Accountability Structure
Clear ownership throughout the study lifecycle.
One Budget
One transparent, tailor made budget with no hidden fees.
What We Manage
From regulatory approvals and site monitoring to project oversight and study management, we provide the expertise needed to support every stage of the device study lifecycle.
A connected delivery team with full study visibility.
Earlier identification of regulatory issues.
Clear accountability across all delegated activities.
Long-term collaboration built around study success.
People who put patients first
A multidisciplinary team bringing together regulatory expertise, clinical operations and study management support to help keep your device study on track.
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Founder with 17 years’ experience leading IVD design engineering projects globally.
Pharma leader with 10 years’ experience managing IVD clinical research programmes.
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Chartered Accountant with 10+ years’ experience leading finance and governance functions.
10+ years’ experience delivering digital products across healthcare, data and regulated industries.
Brings over 10 years’ experience in clinical, quality and regulatory consulting for global precision medicine studies.
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30+ years’ expertise in people leadership, organisational development and culture.
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9 years assay development & validation experience. 3 years early phase clinical trials.
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20+ years’ expertise in global regulatory affairs and clinical compliance across pharmaceuticals and diagnostics.
12+ years of experience in diagnostics, clinical trials, NGS, and biomarker discovery.
Research operations leader experienced in diagnostics, pharmaceuticals, quality assurance, and project management.
Research operations leader experienced in diagnostics, regulated laboratories, biomarkers, and project delivery.
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Quality leader with 20+ years’ experience in regulated healthcare environments.
Chartered Biologist experienced in laboratory operations, technical management, quality, and regulatory compliance.
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IVD specialist with 14 years’ experience developing small molecules and ADA programmes.
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10 years commercial experience across pharma, sterile IV manufacturing and precision diagnostics.
Explore expert perspectives, industry developments, and practical guidance across clinical research and CRO services.
A coordinated approach that combines key study activities under one delivery model.
Regulatory, clinical operations and study management support.
Yes. Choose specific work packages or a fully delegated model.
By improving visibility, accountability and coordination across your study.
Yes. We support multi-country studies throughout the study lifecycle.
Specialist expertise in precision medicine trials, regulatory compliance and clinical operations.
Connected Programme Support
ARC brings together regulatory, clinical, laboratory and technology expertise to support diagnostic programmes from development through delivery.
The ARC team welcomes the opportunity to connect with you, share our real-life experiences and help navigate your business as you find kinder patient treatments.
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