ARC360®: Designed for the Real Challenges of Regulatory Submissions

In today’s fast-moving regulatory environment, organisations working in precision medicine are under relentless pressure. Globalisation has expanded the complexity of clinical trial submissions. Teams are stretched across time zones, regulatory frameworks evolve constantly, and the stakes for accuracy, speed, and compliance have never been higher. 

At ARC, we know these challenges because we experience them every day alongside our clients. We’ve seen submission teams bogged down by siloed processes, duplicated effort, and fragmented visibility. We’ve listened as managers shared their frustration with unpredictable approval timelines and ever-changing global requirements. And we’ve understood the impact this has such as delayed studies, increased risk, and the slowing of innovation in healthcare. 

That’s why ARC360® was built - not as another “platform with features,” but as an extension of ARC’s regulatory expertise, specifically designed to solve the problems our clients face most. 

Understanding Our Customer’s Challenge 

1. Submissions at global scale
   Building submissions across 50+ countries is not just an administrative challenge, it’s a strategic risk. Templates differ, timelines clash, and teams need to stay compliant in every market simultaneously.
2. The visibility gap
   Managers and contributors often lack a real-time picture of what matters most. When teams can’t see dependencies, bottlenecks, or changing requirements clearly, timelines slip.
3. Regulatory uncertainty
   Guidance and reporting obligations shift constantly. Study leads need intelligence they can trust, curated and relevant, rather than drowning in information that is outdated or incomplete.
4. The human factor
   At the heart of every regulatory process are people- researchers, clinicians, regulatory specialists. They need to collaborate across functions, manage tasks fluidly, and know their contribution is aligned with the bigger picture.

How ARC360® Responds 

ARC360® doesn’t simply digitise regulatory processes, it is shaped by real-world experience and client feedback to remove friction, reduce risk, and empower global teams. 

• Study Collaboration Workspace – Designed to centralise and standardise submissions, ensuring global consistency while reducing duplication. 

• Manager & User Dashboards – Providing clarity in the chaos, giving each team member and manager the ability to focus on what matters most. 

• Reduced Approval Timelines - Visualising task dependencies to keep momentum across every contributor. 

• Curated Regulatory Intelligence - Delivering global, tailored insights so organisations can act with confidence, not guesswork. 

• Real-Time Task Management - Ensuring that when requirements or assignments change, teams know instantly. 

Each of these capabilities exists not because they are “nice to have,” but because clients asked for them, and ARC listened. 

Evolving with Clients, Not Ahead of Them 

ARC360® is not a static product. It’s an ecosystem growing, adapting, and evolving with the organisations who use it. Every new feature is rooted in empathy for the challenges clients face today, with a commitment to staying ahead of tomorrow’s regulatory shifts. 

The future of precision medicine depends on more than regulatory compliance; it depends on the ability to accelerate safe, effective treatments to patients. ARC360® is here to make sure our clients are not just compliant, but truly competitive in a landscape where speed and precision save lives. 

Shaping the Future of Submissions 

ARC360® is not simply about technology - it’s about recognising the very real pressures faced by submission teams and responding with tools that make their work more manageable, more predictable, and more effective. By listening closely to our clients, we’ve shaped a platform that aligns with the way teams truly operate. 

As the regulatory landscape grows more complex, ARC360® will continue to evolve together with those who rely on it - ensuring that every submission is not only compliant but delivered with confidence. 

To truly understand how ARC360 can help you achieve your regulatory goals, quicker and at less cost, get in touch today!

Email Ashley Sloan: [email protected]