Monday, 24 July 2017

PAREXEL expands regulatory management services

14 April 2016 | News | By BioSpectrum Bureau

PAREXEL partners with EMC to provide regulatory management services

PAREXEL has developed Regulatory Cloud, a life sciences content and regulatory information management solution

PAREXEL has developed Regulatory Cloud, a life sciences content and regulatory information management solution

Singapore: PAREXEL International has partnered with EMC Corporation to offer an end-to-end Regulatory Information Management (RIM) and Regulatory Content Management solution.

By combining PAREXEL LIQUENT InSightRegulatory Information Management platform and EMC Documentum for Life Sciences software solution suite, PAREXEL now provides life sciences companies with a complete solution for a product's entire regulatory lifespan. Life science companies can utilize the solution for strategy and planning, authoring, publishing, submitting, viewing, archiving, and lifecycle management for a product. The offering is available through PAREXEL's Regulatory Cloud, a life sciences content and regulatory information management solution structured within a dedicated, private cloud environment.

"A life sciences company must navigate the complex, global and region-specific regulatory landscape to maintain registration and compliance for a product," said Dr Paul Bidez, vice president and global head of regulatory solutions, PAREXEL. "To help solve this challenge for our clients, PAREXEL and EMC brought together our respective industry-leading regulatory information management platform and industry-leading life sciences content management solution suite within PAREXEL's Regulatory Cloud."

PAREXEL's Regulatory Cloud utilizes identity-based security that ensures that only authorized users can gain access to the infrastructure and application resources they require. Applications can be configured or integrated to meet client-specific requirements.

The EMC Documentum for Life Sciences software solution suite can eliminate companies' data silos to transform how organizations access, manage and share information across nonclinical, clinical, quality and regulatory groups, ensuring a single, authoritative source for regulated content.

"Industry pressures are prompting biopharmaceutical organizations to adopt new business models, enter new global markets, and expand alliances and partnerships. To achieve these goals, Life Sciences organizations are becoming more strategic in how they manage information," said Rohit Ghai, president, enterprise content division, EMC. "By partnering with PAREXEL, we're enabling these organizations to digitally transform and deliver high-quality, safer drugs to market faster and at a lower cost, while meeting regulatory requirements."

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