ARC360®
ARC360® is a Regulatory Intelligence & Execution Platform built for global clinical studies - helping sponsors and study teams navigate country-specific requirements, reduce start-up delays, and manage regulatory delivery with confidence.
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WHY STUDIES GET DELAYED
Evolving requirements across different countries create uncertainty, increase administrative burden, and raise the risk of missed obligations during study start-up and delivery.
Country submissions, approvals and dependencies are often tracked across spreadsheets and disconnected systems.
Sponsors, CROs and study teams struggle to maintain alignment across multiple regions and stakeholders.
Teams spend valuable time chasing updates, preparing reports and managing documentation.
Evolving requirements create uncertainty and increase the risk of missed obligations.
WHY IT MATTERS
Delayed study start-up affects more than project plans. It can slow patient access, increase operational pressure, and create avoidable costs across the study lifecycle.
Study Delays
Missed or unclear requirements can slow approvals, site activation, and study progress.
Patient Impact
Every delay can postpone access to studies that may offer important diagnostic or treatment pathways.
Cost and Resource Pressure
Delays increase operational costs, stretch internal teams, and create pressure across sponsors, CROs, sites, and vendors.
In some cases, industry commentary estimates that reducing clinical trial timelines by six months could protect $90–150M in value. ARC360 helps address avoidable regulatory delays through clearer requirements, real-time submission visibility and expert-led study oversight.
PLATFORM FEATURES
ARC360 combines country-specific regulatory intelligence, expert review and practical study oversight to support global clinical trial delivery.
Access regulatory intelligence across 40+ countries, with applicable changes monitored to support compliant study planning and delivery.
Support sponsors, CROs, sites and ARC teams in one controlled environment with role-based access and shared visibility.
Track progress from study kick-off to submission and approval with centralised visibility across milestones, documents and responsibilities.
People who put patients first
ARC360® combines structured regulatory intelligence, platform-enabled delivery, and expert oversight from teams experienced in global clinical study requirements.
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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.
THE ARC360® ADVANTAGE
ARC360® provides the visibility, structure, and control clinical teams need to manage regulatory activities with confidence. From planning and collaboration to reporting and oversight, every feature is designed to support successful trial delivery.
Every day a trial is delayed, costs increase, resources are stretched, and patient access is postponed.
ARC360® helps organisations improve regulatory execution by bringing visibility, accountability, and predictability to study delivery.
Reduce delays caused by poor visibility and manual processes.
Understand where studies stand and identify risks before they impact delivery.
Enable teams to work more effectively through improved visibility and collaboration.
Use the ARC360® ROI calculator to explore how improved visibility, reduced manual effort, and faster study start-up could impact your clinical trial operations.
Stay informed on pharmaceutical technologies, industry trends, and emerging developments shaping clinical research.
ARC360 provides visibility, accountability, and structured regulatory workflows that reduce delays and rework.
Teams can plan, track, and manage country submissions through a centralised platform.
ARC360® includes regulatory intelligence for 40+ countries, with updates reviewed daily and applied where relevant to clinical study requirements.
Sponsors, CROs, regulatory teams, and study stakeholders managing global clinical programmes.
Role-based access enables secure collaboration between internal and external teams.
ARC360® combines regulatory expertise with technology to improve predictability and execution.
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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