BOSTON, March 31, 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.
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:
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.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.