PAREXEL enhances its Regulatory Cloud; leverages EMC® Documentum® for Life Sciences software solution suite to offer an end-to-end regulatory solution
LONDON, 13th April, 2016 - PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services organisation, and EMC Corporation (NYSE: EMC) today announced they have entered into an alliance to offer an end-to-end Regulatory Information Management (RIM) and Regulatory Content Management solution.
By combining PAREXEL® LIQUENT InSight® Regulatory 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 utilise 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 Paul Bidez, Ph.D., 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 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 companies’ data silos to transform how organisations 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 utilises 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.
“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.”
Regulatory Cloud is offered by PAREXEL directly or through the Company's Perceptive® Partner Program.
About LIQUENT InSight
Since the market introduction of LIQUENT InSight in 2004, 16 of the top 20 pharmaceutical companies have selected the LIQUENT InSight platform as their authoritative source of regulatory information. PAREXEL’s RIM technologies can also be coupled with comprehensive professional services from PAREXEL, which provides a full complement of Regulatory Outsourcing Services to help companies meet the demands of today’s complex and changing regulatory environment.
About EMC Documentum for Life Sciences software solution suite
Over 75% of leading life sciences firms rely on EMC Documentum. Our tightly integrated solutions deliver standardized business processes that simplify access to content. 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. Organizations can create a single authoritative source for regulated content, seamlessly link and share content across departments (or divisions) and provide proactive notifications to document authors, owners and users when document changes take place or actions and tasks are required. The suite includes: EMC Documentum Electronic Trial Master File, EMC Documentum Research and Development, EMC Documentum Submission Store and View, and EMC Documentum Quality and Manufacturing.
EMC Corporation is a global leader in enabling businesses and service providers to transform their operations and deliver IT as a service. Fundamental to this transformation is cloud computing. Through innovative products and services, EMC accelerates the journey to cloud computing, helping IT departments to store, manage, protect and analyze their most valuable asset — information — in a more agile, trusted and cost-efficient way. Additional information about EMC can be found at http://www.emc.com/.
EMC and Documentum are registered trademarks or trademarks of EMC Corporation in the United States and other countries. All other trademarks used herein are the property of their respective owners.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of expertise-based contract research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 77 locations in 51 countries around the world and had approximately 18,200 employees in the second quarter. For more information about PAREXEL International, visit www.PAREXEL.com.
PAREXEL is a registered trademark of PAREXEL International Corporation. All other trademarks are the property of their respective owners.
This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. Such factors and others are discussed in the section entitled “Risk Factors” of the Company’s most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q as filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.
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Sue Grant/Charlotte Bass
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