Test Site Monitoring
Flexible on-site and remote monitoring support to maintain protocol compliance, data quality, patient safety and consistent study delivery across diagnostic programmes.
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WHERE STUDIES COME UNDER PRESSURE
Diagnostic studies depend on accurate documentation, consistent processes and timely action. ARC helps sponsors detect issues earlier, strengthen site performance and protect study quality throughout delivery.
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We review site activity against the approved protocol, study procedures and monitoring plan.
We assess records and study data for completeness, consistency and traceability.
We help maintain clear expectations across all participating sites.
Findings are documented, escalated and tracked through to resolution.
Ensure site compliance with national and international standards such as ISO15189 and ISO20916.
BUILT AROUND THE STUDY
ARC provides customised remote, on-site and hybrid monitoring tailored to study risk, programme complexity and site performance.
ARC provides monitoring support at key study milestones or continuous oversight from study start-up through to close-out, helping maintain clear expectations, consistent documentation and timely issue resolution.
GLOBAL TEST SITE MONITORING
With monitors across the US, EU, China, Singapore and beyond, ARC combines global coverage with established relationships across major diagnostic providers to deliver effective test-site monitoring.
People who put patients first
Meet the team dedicated to guiding you through complex healthcare regulations with clarity, empathy, and expertise.
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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.
ARC supports IVD, companion diagnostic and precision medicine studies, including clinical performance studies delivered across single or multiple test sites.
Yes. Monitoring can be delivered remotely, on-site or through a hybrid approach. The delivery model is shaped around study complexity, site performance, identified risks and sponsor requirements.
The scope may include study conduct, protocol compliance, source records, essential documents, data quality, training records, specimen workflows, device accountability and outstanding site actions.
Yes. ARC can assess site suitability and readiness, then support initiation activities to ensure teams understand the protocol, study procedures, responsibilities and documentation requirements.
Findings are documented, assessed and communicated through agreed escalation pathways. Actions can then be assigned, tracked and followed through to verified completion.
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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