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BOSTON—PAREXEL International Corp., a global biopharmaceutical services organization, has entered into an alliance with EMC Corporation to offer an end-to-end regulatory information management (RIM) and regulatory content management solution. In the collaboration, PAREXEL will enhance its Regulatory Cloud and leverage the EMC Documentum for Life Sciences software solution suite.
“Life-sciences companies are under pressure to balance innovation with cost-cutting measures across the enterprise,” explained Lena Shafir, product manager for regulatory solutions in the enterprise content division of EMC. “They need to reduce the costs of regulatory operations and speed up health agency approvals to accelerate time to market. Effective RIM strategy and solution implementation allow organizations to stay competitive, compliant and informed. While providing needed medicine to patients quickly is an honorable objective, delivering on it is easier said than done.”
Combining the PAREXEL LIQUENT InSight RIM platform and EMC Documentum for Life Sciences software solution suite, PAREXEL says, gives life-sciences companies a complete solution for a product’s entire regulatory lifespan. Life-sciences companies can use 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 RIM solution structured within a dedicated, private cloud environment.
Sixteen of the top 20 pharmaceutical companies have selected the LIQUENT InSight platform as their authoritative source of regulatory information since its introduction in 2004. PAREXEL’s RIM technologies can be coupled with comprehensive professional services from PAREXEL, which provides a full complement of regulatory outsourcing services.
According to Dr. Paul Bidez, vice president and global head of regulatory solutions at PAREXEL. “A life-sciences company must navigate the complex, global and region-specific regulatory landscape to maintain registration and compliance for a product. 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.”
The Regulatory Cloud’s identity-based security reportedly ensures that only authorized users can gain access to the infrastructure and application resources they need. Applications can be configured or integrated to meet client-specific requirements.
The EMC Documentum for Life Sciences software solution suite is said to be able to eliminate companies’ data silos to transform the way in which organizations access, manage and share information across nonclinical, clinical, quality and regulatory groups, ensuring a single, authoritative source for regulated content. The fully-integrated suite leverages industry standards and utilizes easily configurable, intuitive and personalized interfaces to maximize productivity and ensure easy access to information. This helps to bring high-quality and safer drugs to market faster, improving health and well-being, while lowering costs.
More than 75 percent of leading life-sciences firms rely on EMC Documentum, according to the company. The EMC Documentum for Life Sciences software solution suite delivers proactive, automated, business rules and enhancements across the suite while ensuring a simple, user experience to reduce risk, streamline processes and boost worker productivity.
“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 of EMC’s Enterprise Content Division. “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.”