Speeding Time to Market and Ensuring Regulatory Compliance with Business Process and Content Management Integration

Imagine if your company could do just that and achieve a return on investment (ROI) on software and services of more than 100 percent in just 18 months.

According to Forrester Consulting, that’s just what happened when a top ten pharmaceutical firm’s Intellectual Property (IP) department implemented an EMC® Documentum® electronic file room (EFR). Forrester Consulting performed a Total Economic Impact (TEI) study of the company’s use of EMC Documentum to eliminate paper-based document systems and the resulting obstacles of slower workflow, higher costs, and reduced productivity. The study found a 113 percent ROI in just 18 months through integration of the department’s business processes with content management.

The pharmaceutical company deployed the EFR based on Documentum enterprise compliance platform (ECP) to support 175 IP attorneys and more than 200 supporting staff located at ten sites in five countries. Total benefits over three years were estimated to have a present value of $17.9 million based on an investment of $8.4 million.

Forrester found that the project led to considerable improvements in the productivity of high-value staff in the IP department, as well as lower costs due to the elimination of paper usage—costs due to physical storage space, priority mail and shipping costs, and the cost of paper itself. In addition to the key aim of better collaboration among global IP colleagues, the project also has reduced the loss of important documents and enabled the creation of new documents faster based on existing work. It has also become a laboratory of sorts for using Documentum in other groups within the company.

If applying enterprise content management to a legal department can produce these kinds of results, imagine the impact when Documentum is applied to a life sciences company’s core processes.

Extending the benefits of Documentum to core life sciences processes

According to the Pharmaceutical Research Manufacturers of America (PhRMA), the average cost of moving a new drug through the development process in the U.S. is well over $800 million. The association also states that drug development takes, on average, 12 to 15 years, leaving only five to eight years of patent protection. In addition, PhRMA notes that only one in 5000 new compound entities actually survives the development process, receives new drug approval, and ultimately reaches the marketplace.

With these statistics, just imagine the potential benefits stemming from a ten to twenty percent productivity improvement in core life sciences business processes. Life sciences organizations can improve productivity, reduce costs, mitigate risks, and ensure compliance by using the EMC Documentum enterprise compliance platform to integrate their core business processes with related content management—internally, across processes, and externally with partners, site investigators, suppliers, and others. These core processes include clinical trials, regulatory submissions, regulatory content (SOPs), marketing, and contract management.

Developed with input in mind from the top 50 life sciences companies, Documentum ECP supports all major business processes across the life sciences value chain. As noted in earlier issues of Next Generation Pharmaceutical, a typical life sciences application sits on top of the EMC Documentum enterprise compliance platform. The Documentum platform provides a unified set of services that can be thought of as “building blocks” that can be easily combined as needed.

EMC Documentum Enterprise Compliance Platform for Life Sciences

EMC Documentum has more than 350 life sciences organizations as customers—including the top 25 global pharmaceutical companies and many regulatory agencies, including the FDA. Below are examples of how some of these companies are utilizing Documentum to optimize work processes and leverage their information assets. The result? Faster time to market and ensured regulatory compliance.

Global R&D collaboration

A global pharmaceutical leader dedicated to discovering and developing innovative drugs and vaccines in areas such as cancer, diabetes, cardio-vascular disease, asthma, and allergies uses EMC Documentum eRoom® to streamline global collaboration between its chemists, biologists, toxicologists, and clinicians. Collaboration was previously performed using e-mail, making it impossible to accurately track versions and maintain project documents in a single, secure area that was accessible to everyone. eRoom captures all project documents, including virtual team meeting results, reports, presentations, and test data. Documents such as new drug feasibility studies, which require collaborative review and editing, can be tightly controlled and managed. All content is seamlessly archived in an EMC Documentum repository. The information now flows seamlessly to preclinical and clinical trials.

Preclinical trials and electronic notebooks

A U.S. affiliate of a worldwide leading pharmaceutical company specializing in the fields of dermatology, diagnostic imaging, female healthcare, therapeutics, and oncology wanted to create a paperless system for capturing and storing the information contained in its research scientists’ handwritten notebooks. The company also wanted to make this important intellectual property more easily accessible and retrievable while ensuring its security. The company deployed Documentum, enabling more than 800 of the company’s globally-based scientists to use Microsoft Word and Excel to log their research, which was stored on local servers and replicated to a central repository each night.

The company can now leverage its intellectual property in ways that were impossible with a paper-based system. Research that is easily searched, retrieved, and shared is more valuable and retains its value far longer than information archived in traditional notebooks.

Clinical trials and regulatory submissions

Accelerating products through clinical trials requires aggregation and efficient management of enormous amounts of content related to new drug applications (NDA). A typical NDA submission is nearly one million pages. When a California-based global pharmaceutical company that specializes in eye care, neuromodulator, and skincare products wanted to securely and efficiently control the flow of NDA-related content, enable accurate versioning, authorize and verify recipients, and track changes involved for electronic submission to, and compliance with, regulatory agencies, it chose EMC Documentum.

The company deployed a fully-controlled environment based on Documentum workflow and lifecycle management. This solution unites the company’s content value chain by controlling all upstream content such as discovery and preclinical trial results and managing it through review and approval to publishing and submission that fully support 21 CFR Part 11. The ability to submit NDAs electronically ensures that each one of the pages is approved and accurate, and that the NDAs have a much better chance of being reviewed quickly without delays to correct faulty documentation.

Manufacturing and SOP management

If a standard operation procedure (SOP) for clinical protocol writing is changed and delayed in review, an in-process protocol may have to be redone once the SOP has been approved. A New York state-based pharmaceutical company focused on the discovery, development, and commercialization of high-quality oncology products wanted to develop an electronic system for creating and managing SOPs that would ensure access from any of the company’s three locations in New York, Colorado, and the UK; reduce the cycle time for SOPs; and ensure the accuracy of SOPs across functional areas. Streamlined SOP management means a reduction in the time and expense of rework. This translates to competitive advantage.

The company deployed the EMC Documentum SOP management solution to gain streamlined review and approval; faster, more efficient access and distribution; and increased accuracy, global consistency, and easier regulatory compliance. With EMC Documentum, electronic review and approval of a final SOP can take just three days—instead of the five weeks using the old system. The single repository enables authorized access to all SOPs anywhere in the world. Through accelerated review and approval and tight version control, EMC Documentum ensures that the distributed version of an SOP is the most recent and accurate. Once an SOP has been approved and certified with a digital signature, it cannot be changed without entering a formal workflow process.

Sales and marketing with web content management

Eliminating the “webmaster bottleneck” and reducing the time needed to publish content to the Web enables life sciences companies to reduce sales and marketing costs. EMC Documentum Consulting and a London-based, leading pharmaceutical company engaged in the research, development, manufacture, and marketing of prescription drugs delivered an XML-based web development infrastructure for quickly and easily creating websites.

The solution featured a generic set of XML templates, reusable lifecycles and workflows, defined business rules, updated menus, and 24x7 support. Workflow automatically routes web content through approvals in an auditable process, which increases content accuracy and diminishes legal liability. Now published, trusted content can be done in a matter of seconds, with no IT involvement required. EMC Documentum dramatically reduced the cost of web development from $75,000 to $25,000 per site.

Other benefits

In addition to the benefits gained through these Documentum deployments, life sciences organizations can derive addition value by establishing a standardized enterprise compliance platform. Specific examples include:

• Reduced costs from consolidation of disparate content management platforms and elimination of annual software maintenance
• Faster solution delivery time based on skilled resources using a standardized ECP with reusable building blocks
• Actual implementation of records management plans typically consisting of unimplemented “file plans”
• Reduced storage costs through storage optimization based on the value of information
• Ability to find and retrieve content faster using federated search

Summary

Moving to a standardized enterprise compliance platform and integrating content management and business processes can deliver real economic benefits to all departments of life sciences organizations. By combining a compliance interface, process services, regulated content services, and repository services in one platform, EMC Documentum enterprise compliance platform enables life sciences organizations to integrate their business processes and content management. The result is management of content at every phase of the value chain—from research and development and clinical trials to regulatory submissions, manufacturing, and sales and marketing.

To learn more about the EMC Documentum enterprise compliance platform, please visit our online life sciences resource kit at http://software.emc.com/ecplatform

To read the Forrester Consulting study, The Total Economic Impact of EMC Documentum, go to: http://www.emcsoftware-info.com/mk/get/01-08-07_TTL_ECON_EMC-DCTM_DL