PAREXEL introduces new version of Regulatory Information Management platform

By: Pharma Tips | Views: 1913 | Date: 06-Apr-2015

PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today introduced the latest version of its Regulatory Information Management (RIM) platform: LIQUENT InSight® 6.0. The LIQUENT InSight platform supports the entire regulatory product lifecycle, from early planning of registration targets through product retirement, with robust submission planning, publishing, viewing and registration management capabilities.

PAREXEL introduces new version of Regulatory Information Management platform

PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today introduced the latest version of its Regulatory Information Management (RIM) platform: LIQUENT InSight® 6.0. The LIQUENT InSight platform supports the entire regulatory product lifecycle, from early planning of registration targets through product retirement, with robust submission planning, publishing, viewing and registration management capabilities.

Regulatory Information Management (RIM)

While biopharmaceutical companies and the patients who can benefit from new drugs are located throughout the world, there is no single international regulatory body to review and approve new medicine applications. For new and innovative medicines to successfully reach patients and maintain regulatory compliance throughout the product lifecycle, biopharmaceutical companies must navigate the complex, global regulatory and region-specific regulations.

"LIQUENT InSight 6.0 simplifies navigation of the global regulatory environment and provides the submission and registration management tools needed to more quickly bring treatments to market and effectively maintain them throughout their lifespan," said Xavier Flinois, President, PAREXEL Informatics. "As an essential part of the drug development journey, the LIQUENT InSight platform centralizes a company's regulatory information to drive standardization, improve collaboration, and helps to ensure compliance, eliminate waste, reduce costs, and increase efficiencies so more patients can quickly and safely receive the treatments they need."

Enhancements to the LIQUENT InSight platform include:

  • Business Intelligence: added robust analytics to enhance reporting capabilities
  • Usability: simplified interface designed by usability experts provide an intuitive experience to all levels of InSight users
  • Compliance: updated data model and architecture helps to ensure processes, output and work product compliance with standards such as XEVMPD and the upcoming IDMP mandate
  • Interoperability: revamped interoperability web services features that help systems interact and communicate with each other

Since the market introduction of LIQUENT InSight in 2004, more than 40 companies (including 14 of the top 20 pharmaceutical companies) have selected the LIQUENT InSight platform as their single source of regulatory information. PAREXEL's RIM technologies can also be coupled with comprehensive professional services from PAREXEL® Consulting, which provides a full complement of Regulatory Outsourcing Services to help companies meet the demands of today's complex and changing regulatory environment. LIQUENT InSight 6.0 will also be available through the Perceptive® Partner Program.

Source:

PAREXEL International Corporation


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