Core Capabilities
Effective Collaboration and Efficiency – Unlocked
Technology uniquely positioned between regulators and industry to power more streamlined communication and information exchange.
Benefits
Real-time Regulatory Collaboration
A collaborative regulatory review process that’s effortless and secure.
Intuitive Technology Built for Regulatory Practices
A technology experience that advances the regulatory process.
Trust Through Transparency
Transparent reviews and decision-making build trust among regulators and industry.
Centralized and Searchable Regulatory Content
Logically organized and searchable content helps regulators find information.
Secure and Compliant Platform
Our cybersecurity infrastructure mitigates risk with the right tools and functional operations.
Collaborative Review and Information Exchange
Life sciences organizations and national regulatory authorities typically collaborate and share information with individuals in a one-to-one exchange. With Invitations, life sciences organizations can invite regulators to collaborate in a shared review within the Accumulus Platform, streamlining the process. They can exchange content, comments, and information securely and effortlessly while minimizing redundant tasks.
Efficient and Transparent Reviews and Decisions
When participating in a shared review within Accumulus, national regulatory authorities can access the same shared content and see their peers’ questions for a life sciences organization. Similarly, participating regulators can also see the life sciences organization’s responses to regulator questions. This enables regulators to ask fewer questions because they can already access other regulators’ answers. Decisions, once made, are available to all participating national regulatory authorities. This transparency reduces review timelines dramatically
A User Experience Designed for the Regulatory Process
Accumulus’ relationships with national regulatory authorities and life sciences organizations have resulted in a platform user experience that meets the needs of the regulatory process. Users are led through guided workflows, tasks, and notifications, making it easy to understand when and how they need to take certain actions.
Easy Access to National Regulatory Authority Questions and Content
Users of the Accumulus platform can locate and access relevant regulator questions and content for a shared and secure regulatory review. The content is organized logically and is fully searchable, so they can find what they need quickly and easily.
“The strength of Accumulus is the simplicity of the design.”
Roche
Senior Regulatory Submission Manager, Roche