DIGITAL REGULATORY INFORMATION MANAGEMENT: A PROVEN BUSINESS-DRIVEN, VALUE-BASED APPROACH
With the complex dynamics in play, life sciences companies must adopt a big-picture Regulatory Information Management (RIM) strategy that drives smarter, faster and lower-cost decision making. The end goal for the life sciences enterprise of the future is an intelligent, interconnected RIM framework that rethinks and recasts the core set of regulatory systems.
CSC’s next-generation RIM approach helps clients drive revenue and compliance, delivering efficiency and effectiveness while reducing risk and cost.
ALLERGY THERAPEUTICS GAINS INCREASED FLEXIBILITY WITH FIRSTDOC UPGRADE
UK-based Allergy Therapeutics is enjoying the benefits of a streamlined regulatory submission process following a cost-effective upgrade to the latest version of FirstDoc, CSC’s life sciences Regulatory Information Management solution. The specialty pharmaceutical company took advantage of CSC’s new approach to FirstDoc upgrades, which gives customers a wider range of options and a more straightforward, simpler upgrade path.
REGULATORY INFORMATION MANAGEMENT SOLUTIONS
Regulatory Information Management (RIM) is crucial both for managing submissions and for informing decision making around the portfolio — particularly in today’s highly complex regulatory and commercial climates. However, companies must ensure that the solutions they adopt meet organizational goals. CSC offers deep domain expertise along with broad understanding of both the technology and the processes required for strong RIM solutions.
GLOBAL DRUG MAKER EISAI SIGNS $7M CONTRACT EXTENSION FOR CSC’S TOTAL REGULATORY SOLUTION (TRS) AS A SERVICE
CSC, a global leader in next-generation IT services and solutions, announced on March 30, 2016, that Eisai Pharmaceutical Company has signed a five-year, $7 million contract extension for CSC's Total Regulatory Solution (TRS) as a Service. The agreement extends until December 2019 the ongoing life sciences software and cloud-hosting services CSC provides to Tokyo-based Eisai Co., Ltd.’s U.S. pharmaceutical subsidiary.
TAKING RIM TO A WHOLE NEW LEVEL
In a blog from John Bell, industry general manager and Americas leader for CSC’s Life Sciences, learn how a strategic approach delivers returns for the whole enterprise. In particular, as clients change their view of Regulatory Information Management (RIM), some important factors should be taken into consideration, such as:
- Platform neutral
- Outsourcing BPS
- In the cloud
CAPITAL-EFFICIENT INNOVATION: A TRANSFORMATIVE PATH FORWARD IN LIFE SCIENCES
Life sciences companies are seeking more efficient and cost-effective ways to respond to changing healthcare dynamics and opportunities. They must innovate to stay ahead of declining pipelines while meeting more stringent regulatory requirements. Partnerships and acquisitions have become commonplace, and that has also led to complexities in how data is shared and integrated, both internally and externally.
All the while, companies are expanding into emerging markets and working in a global ecosystem. This has increased their need for agility to respond to changing compliance requirements from regional health authorities, as well as scalability of infrastructure and the ability to manage big data to improve analytics. To meet these challenges and opportunities, CSC has adopted a bold and progressive approach called Capital-Efficient Innovation.
RIM IN THE CLOUD WHITE PAPER
Worried about meeting stringent security requirements and complying with complex regulations, some life sciences IT leaders have been hesitant to move to the cloud. They wonder whether cloud computing is secure enough to meet the needs of life sciences organizations, or whether it can meet tough regulatory requirements.
Cloud computing offers the value and flexibility that can help life sciences enterprises speed up product development, simplify data exchange and ultimately produce better patient outcomes. Recent improvements in cloud technologies have led to more sophisticated services that feature enhanced security and a clear path to successful regulatory compliance.
SEEING THE BIG PICTURE: WHY RIM HAS TO BE MORE THAN REGULATORY SOFTWARE
In a blog by Gurdip Singh, vice president and general manager, Healthcare and Life Sciences Software and Solutions, he observes that in his conversations with clients, one trend that is becoming apparent is the need for a far more comprehensive approach to managing regulatory information across the enterprise.
Organizations are looking for their service provider partners to help them leverage their information and achieve greater efficiencies, and this needs to go beyond software. But while he is seeing more vendors enter the registration management solutions market, this is only a small element of a much broader emerging Regulatory Information Management (RIM) landscape.