What We Do

Paving the way for advancement of regulatory interactions

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What We Do

Paving the way for advancement of regulatory interactions

Our Platform

Collaboration. Information. Data exchange.

We are working towards a shared goal of getting medicines to patients faster by leveraging cloud technology.

Our goal is to enhance the current methods of information and data exchange by helping to provide a digital path forward for increased regulatory harmonization.  We envision information exchange between life science organizations and global health authorities evolving from the traditional dispatch of static information and documents to a cloud-based environment where up-to-date data can be transmitted and analyzed in a more dynamic way, while still making sure all aspects of confidentiality and security are in place.

The Accumulus Synergy Platform is being built to enable near real-time exchange of information, including data, as it becomes available throughout the drug development lifecycle. Centralizing interactions between drug developers and health authorities within a cloud environment will serve to create an up-to-date, referenceable repository for the exchange of information and data. Our Platform is designed to:

  • Provide each organization their own space, with content remaining with the originating organization
  • Comply with different countries’ security and privacy parameters, ensuring that data is secure and encrypted to the highest degree
  • Allow for sharing of select data and information through multi-tenant spaces, with controlled access
Hal Stern

“We can have a faster, more collaborative review process that ideally brings medicines to market faster for patients. It’s always been important; now it’s possible.”

– Hal Stern VP, Head of Technology R&D, at Janssen

Collaboration Capabilities

Collaboration Capabilities to Demonstrate Efficiency Improvement.

We are working to enable concurrent, fit-for-purpose tools to enhance collaboration among regulatory stakeholders in a secure environment to manage data and information within and across organizations.

The Accumulus Platform is being built to be an intuitive communication tool, which aims to centralize and streamline health authority to health authority and life sciences organization to health authority interactions.

The Vision for Regulatory Collaboration

Planned Foundational Features

  • Templated projects
  • Collaboration workspaces created per project with non-restrictive combinations of collaborations
  • Workflow with dynamic access controls
  • Persona-specific real time dashboard
  • Calendar-centric project management with milestones and meeting facilitation
  • Interactive and dynamic cross health authority collaboration, including health authority invitation processes
  • PDF document ingesting/scraping, structured content management support, near real-time collaboration
  • Shared information request library powered by natural language processing

Our Approach

Data-Centricity Will be at the Core of the Accumulus Synergy Platform.

We aim to offer innovative technologies that have the capability to enable tremendous progress in the regulatory space.

Our goal is to enhance the current method of information and data exchange by creating a multi-tenant platform that enables efficient insight generation and aids with regulatory convergence. This can facilitate the bilateral exchange between industry and health authorities and foster inter-health authority collaboration, ultimately benefiting patients around the globe. To achieve this, we will focus on delivering a cloud platform that aims to allow for the exchange of structured data in alignment with changing regulatory needs.

The Vision for Data Exchange

The Platform aims to allow users the ability to

  • Store validated regulatory data in a common format
  • Automatically map terminology across jurisdictions
  • Construct templated filings from common data
  • Exchange structured filings with global regulators
  • Flexibly import/export data through key integrations
Data Centricity

We are committed to supporting the development of standards central to solving today’s
interoperability challenges and are a proud member of Health Level Seven International.

“HL7 ” and “Health Level Seven,” are registered trademarks, and the HL7 design is a trademark of Health Level Seven International.