Parexel enhances Regulatory Cloud and leverages EMC Documentum for Life Sciences software to offer regulatory solution
Parexel, a global biopharmaceutical services organisation, and EMC Corporation, have entered into an alliance to offer an end-to-end regulatory information management (RIM) and regulatory content management solution.
By combining Parexel’s LIQUENT InSight Regulatory Information Management platform and the EMC Documentum for Life Sciences software, Parexel now provides life sciences companies with a solution for a product’s entire regulatory lifespan.
Life science companies can use the solution for strategy and planning, authoring, publishing, submitting, viewing, archiving and product lifecycle management. 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 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 life sciences content management solution suite within Parexel’s Regulatory Cloud.’
Parexel’s Regulatory Cloud uses identity based security that ensures that only authorised 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 company data silos to transform how organisations access, manage and share information across non-clinical, clinical, quality and regulatory groups, ensuring a single, authoritative source for regulated content. The fully integrated suite leverages industry standards and uses easily configurable, intuitive, and personalised interfaces to maximise 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, the firm said.
‘Industry pressures are prompting biopharmaceutical organisations to adopt new business models, enter new global markets and expand alliances and partnerships. To achieve these goals, life sciences organisations 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 organisations to digitally transform and deliver high-quality, safer drugs to market faster and at a lower cost, while meeting regulatory requirements.’