blog

Unlocking Precision Medicine: How ARC360® Streamlines IVDR Compliance to Accelerate Clinical Trials

Bridging the Gap: How ARC360® Addresses IVDR Challenges to Accelerate Precision Medicine Trials in Europe

The European clinical trial ecosystem, once a global leader, is facing a critical juncture. While initiatives like the EU Clinical Trials Regulation (CTR) aimed to harmonise processes, Europe’s share of global trials has declined sharply—from 18% in 2013 to just 9% in 2023. A key driver of this trend is the In-Vitro Diagnostic Regulation (IVDR), which has introduced stringent requirements for diagnostic devices used in trials. These challenges are particularly acute in precision medicine, where in-vitro diagnostics (IVDs) are essential for patient selection, stratification, monitoring, and clinical trial success.

The IVDR Challenge: Complexity Slowing Progress

The IVDR, which came fully into force across the EEA in May 2022, overhauled the regulatory framework for IVDs, requiring stricter oversight of Notified Bodies, reclassification of device risks, and enhanced post-market surveillance. While these changes improve patient safety, they have inadvertently slowed clinical trials:

Operational Delays: Due to compliance hurdles, oncology and rare disease trials, which rely heavily on IVDs for biomarker testing, face prolonged timelines

Reduced Phase 1 Activity: Europe’s share of early-phase trials, including cell and gene therapies, has dwindled as sponsors shift to regions with more predictable pathways.

Fragmented Implementation: Variability in IVDR adoption across EU member states creates confusion, complicating multi-country trials.

The result? Europe risks losing its edge in precision medicine, where timely access for patients to innovative diagnostics and therapies is critical.

How IVDR Impacts Precision Medicine Trials

Precision medicine trials depend on IVDs to identify eligible patients, monitor treatment efficacy, and validate biomarkers. Under IVDR, sponsors face:

Increased Administrative Burden: Sponsors must navigate complex documentation and regulatory approvals for unapproved IVDs in clinical trials, that differ across member states, delaying trial starts.
Patient Recruitment Challenges: Limited access to interoperable health data systems slows the identification of niche patient populations.
Cost Escalation: Reclassification of IVDs to higher risk categories raises costs for developers, deterring investment in EU-based trials.

These barriers align with the recent EFPIA report’s findings of declining trial starts in oncology, neurology, and rare diseases—key areas for precision medicine.

ARC360®: Empowering Precision Medicine Trials Under IVDR

The EU’s In-Vitro Diagnostic Regulation (IVDR) has introduced complex compliance hurdles for precision medicine trials, slowing biomarker-driven research and multi-country collaborations. ARC Regulatory’s ARC360® platform is purpose-built to navigate these challenges, offering a comprehensive suite of tools to streamline IVDR compliance, accelerate trial timelines, and foster stakeholder collaboration.

ARC360 provides a one-stop shop for regulatory intelligence and IVD requirements, ARC360 is the first place the team go to because it provides highly detailed information for clinical trials within minutes saving us months of research to support our global strategy.

Global Pharmaceuticals Company,
Executive Director, Regulatory Affairs, In Vitro Diagnostics

ARC360®: A Tailored Solution for IVDR Complexity

ARC360® is more than a regulatory platform. It’s a dynamic ecosystem designed to address the specific pain points of precision medicine trials in the IVDR era. Here’s how it works:

Real-Time Regulatory Intelligence & Global Coverage

Regulatory Navigator: Stay ahead of evolving interpretations across EU member states with real-time updates on national requirements, Competent Authority expectations, and ethical committee guidelines.
Global Reach: Access detailed regulatory pathways for 40+ sample collection sites (e.g., Germany, Japan, USA) and 7 central lab locations (e.g., Singapore, Switzerland), with ongoing expansions into Asia-Pacific and South America.

2. Study Collaboration Workspace

Study Dashboards: See at a glance all of the IVDR studies you’re working on, the status of the submission preparation and your deliverables to enable submission success. Drill into the details of the submission tasks and timelines and generate reports for study stakeholders.
Centralised Workflows: Simplify multi-country submissions with detailed pre-populated task flows, customisable to include internal process steps or to add deficiency tasks from competent authorities.
Checklists: For EU Performance Study Applications (PSAs), FDA Investigational Device Exemptions (IDEs), and country-specific Annex XIV requirements.
Task Automation: Assign roles, set deadlines, and track progress across teams, reducing administrative delays.
Essential Document Template Library: Accelerate document preparation with pre-approved templates for Clinical Performance Study Plans (CPSPs), Investigator Brochures (IBs), site setup checklists and more.

3. Laboratory Toolkit for Compliance Excellence, for rapid compliance with Article 5(5)

ISO Standards Training and SOP/WI templates: Self-serve modules on ISO 15189, ISO 14971, and ISO 13485, empowering Health Institution Laboratories to meet the requirements of the In-House Exemption.
Risk Mitigation: Proactively address IVDR reclassifications with tools for device risk assessment and GSPR compliance.

4. Scalable Solutions for Every Organisation

Flexible Pricing:

Regular Tier: (£1,500/month): Ideal for small CROs or biotech firms, offering access to 10 sample sites and 3 central labs.
Professional Tier: (£4,000/month): Unlimited global access for pharma/IVD companies managing multi-regional trials.
Enterprise Tier: Tailored packages with dedicated SME support for complex, large-scale trials.

Innovation Roadmap: AI and Beyond

ARC360®’s 2025 development plan integrates cutting-edge technologies to future-proof compliance:

LLM Enabled IVD Assessment Tool: Work through the tool to assess the regulatory status of all IVDs in your clinical trial.
AI-Driven Submissions: Machine learning algorithms predict regulatory gaps and optimise “Right First Time” submissions based on our library of Competent Authority deficiency reporting.
APIs for Global Integration: Seamlessly connect with regulatory platforms (e.g., FDA, EMA) for real-time data exchange.
Expanded Coverage: 50+ sample collection sites and 15 central lab locations by 2026, prioritising emerging precision medicine hubs.

Why ARC360®?

Mitigate Trial and Programme Risk: Turn IVDR compliance from a barrier into a competitive advantage.
Accelerate Timelines: Slash approval delays with automated workflows and global regulatory insights.
Empower Teams: Bridge between sponsors, CROs, and labs through unified collaboration.

ARC360® is revolutionising the way organisations access regulatory intelligence and tailor study-specific information and guidance based on how they are using in vitro diagnostics to select and manage patients in IND/IMP trials. A truly unique offering, powered by the latest technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360® is set to accelerate typical timelines for initiating complex clinical trials.

Seamus Kearney,
CEO, ARC Regulatory.

Transform IVDR Compliance into Opportunity

With ARC360®, precision medicine trials no longer need to choose between speed and compliance. [Contact ARC Regulatory](#) to unlock a faster, smarter path to trial success.

The Path Forward: Europe’s clinical trial ecosystem cannot afford stagnation. With precision medicine driving the future of healthcare, tools like ARC360® are essential to:

Restore Competitiveness: Simplify IVDR compliance to attract trials back to Europe.
Accelerate Innovation: Fast-track biomarker-driven studies for oncology, rare diseases, and cell therapies.
Empower Stakeholders: Bridge gaps between regulators, sites, and sponsors through data-driven collaboration.

As the report underscores, “government investment and policy levers are critical to attracting private sector investment.” ARC360® aligns with this vision, offering a scalable solution to reclaim Europe’s position as a clinical trial leader.

Ready to navigate IVDR and other global IVD regulations with confidence? Discover how ARC360® can transform your precision medicine trials by downloading our brochure today.