ArisGlobal launches LifeSphere Regulatory platform with GenAI integration

ArisGlobal has announced the launch of its new LifeSphere Regulatory platform, designed to manage regulatory affairs comprehensively. This unified platform aims to streamline the regulatory workflow, enhancing both visibility and data quality for organisations.

The company claims that the cloud-based platform can demonstrate efficiency gains of over 50% in regulatory operations by integrating data, content, and processes into a single ecosystem. Moreover, the platform is interoperable with LifeSphere Safety and Quality systems.

A notable feature of the platform is the inclusion of LifeSphere NavaX, a next-gen cognitive computing engine that leverages Generative AI (GenAI) and Large Language Models (LLMs) to support content ingestion, generation, and provide enhanced insights. Organisations using LifeSphere Regulatory can optionally embed LifeSphere NavaX to capitalise on these capabilities.

The ecosystem of products under the new LifeSphere Regulatory platform includes:

• Regulatory information management (RIM): This increases data quality and provides global oversight and control with capabilities for product information management, regulatory planning, and data management.
• Products compliance: Manages data submissions through various phases - submission, post-submission, and post-approval—according to IDMP requirements and operating models.
• Documents: Provides a comprehensive content repository for document and content management with features like template management, workflows, advanced rendering, and permissions.
• Submission management & publishing: Combines submissions and publishing workflows into a single solution that simplifies creating, compiling, and publishing submissions in any format.
• Labeling: Streamlines end-to-end labelling change management and compliance tracking workflows to foster greater efficiency and consistency.
• Regulatory analytics: Uses preconfigured sets of dashboards and reports to meet common regulatory tracking, reporting, and analytical needs.

The platform is already proving beneficial for early adopters who are reporting efficiency gains of up to 50%. Specific enhancements facilitated by GenAI and LLMs include improving the intake of Health Authority (HA) communications and enabling better monitoring for regulatory updates to maintain compliance amid changing regulations.

Commenting on the launch, Ann-Marie Orange, CIO and Global Head of R&D, stated, "With more than 35 years of experience in life sciences technology, ArisGlobal is the only technology company offering strong Safety, Regulatory, and Quality Management solutions powered with next-generation cognitive computing, delivering unmatched interoperability across the R&D IT ecosystem."

She went on to mention significant investments the company has made over the last 18 months. "ArisGlobal has made significant investments in the strategic acquisitions of Amplexor Life Sciences and SPORIFY, along with technology R&D - and we are not stopping," she stated.

Orange emphasised the benefits for existing customers, saying, "For current LifeSphere Regulatory customers, the new platform will provide an enhanced experience and the ability to deploy the latest technologies, all with simple migration. For organisations looking to drive ROI with a new technology approach to Regulatory Affairs, LifeSphere Regulatory is the most advanced option and a real gamechanger for this industry."

ArisGlobal claims to be the first life sciences R&D technology company to offer targeted solutions that effectively utilise GenAI in the industry. The company also continues to host the industry-leading GenAI Council, bringing together top pharmaceutical executives, academia, and AI thought leaders to further fuel the adoption of next-generation technologies across life sciences.