advancing life sciences—from the inside embedding oracle ...€¦ · executive overview in...

An Oracle White Paper May 2010

Advancing Life Sciences—From the Inside Embedding Oracle Technologies in Life Sciences Solutions

Embedding Oracle Technologies in Life Sciences Solutions

Executive Overview............................................................................. 1 Introduction ......................................................................................... 2 Embed Oracle Technologies for Optimized Results............................ 4

Build or Buy?................................................................................... 4 Oracle Is #1 in Life Sciences........................................................... 5 Benefits of Partnering with Oracle................................................... 5 Address Common Problems Life Sciences Companies Face......... 6

Use Scalable Technology to Manage Large Data Volumes................ 6 Support High Performance Computing Grids.................................. 6

Integrate Unstructured Datatypes ....................................................... 8 Store Information in Specialized Network Data Models .................. 8 Manage Multimedia Data ................................................................ 8 Deliver a “Real-World” Perspective with RFID and Sensor Data .. 10

Integrate Silos of Information from the Edge to the Enterprise ......... 11 The Power of Service-Oriented Architectures............................... 12

Collaborate to Enhance Product Development ................................. 13 Improve Business Insight and Reporting .......................................... 14 Increase Information Security and Ensure Regulatory Compliance.. 15

Meet Global Data Security Requirements..................................... 15 Implement Better Access and Identity Management..................... 16

Conclusion ........................................................................................ 16 Appendix ........................................................................................... 18

A Sample Integrated Data Processing Model for Drug Discovery. 18


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Executive Overview

In today’s highly regulated and competitive environment, life sciences companies face ever-increasing demands as they work to develop products that are innovative and profitable. As independent software vendors (ISVs) and original equipment manufacturers (OEMs), you are often tasked with creating state-of-the-art solutions to help these companies discover, produce, and distribute successful products. Whether you manufacture medical instruments or devices, develop software used to analyze compounds or manage clinical trials, or market servers that capture data from equipment across the enterprise, your customers look to you to help them succeed. They strive to accelerate and optimize discovery and product development, improve the efficiency and outcomes of clinical trials, reduce manufacturing risk, maintain product quality, and protect the integrity of the supply chain.

There are many technological challenges to attaining these goals. The product development lifecycle typically requires the technology to manage a massive amount of data, the methods to discover patterns and insights, the capability to perform statistics and regular expression searches, and the means to ensure secure data management and collaboration throughout the process. Furthermore, a growing number of life sciences solutions combine devices and information technology, which adds complexity to quality assurance and regulatory compliance processes.

IT departments of all sizes increasingly rely on self-managing systems to help them overcome challenges with lower cost and risk. By using embedded Oracle technology as transparent building blocks in applications or devices, ISV and OEM solution developers can offer robust data management capabilities, while concentrating on meeting the industry-specific needs of their markets. And because the embedded products are essentially invisible to application users, you gain greater control of the complete application—from installation to management and support. Oracle embeddable products make it easier to develop, manage, and deploy solutions. They provide a long-term return on investment by offering security, reliability, and scalability to support the exacting demands of your customers.


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Oracle is the market leader in embedded database technologies according to IDC1and a global provider of solutions and technology. Oracle Database technologies and applications are running in all the top 20 life sciences companies as well as the top 20 medical device companies. Embedding Oracle technology means products get to market faster, more cost effectively, and with longer-term profitability.

Introduction

The life sciences services market consists of companies that develop and support solutions to improve product discovery, development, and manufacturing in the pharmaceutical, biotechnology, and medical device industries. These solutions may include equipment such as analytical tools, instruments, consumables and supplies, as well as services such as clinical trial management and contract research activities.

Globalization, industry consolidation, and competition from generic manufacturers and new market entrants have intensified cost pressures across the industry. Moreover, advances in technology continue to enable more-precise medical diagnoses and individualized drug responses—leading to a push for targeted products or so-called “personalized medicine.” However, the costs for bringing these niche products to market are comparable to those for products with blockbuster profit potential. Thus, improving the efficiency of the research, development, manufacturing, and distribution processes is critical to the success of a life sciences company.

Outsourcing has become a viable option as a means to control product development cost and risk. New technologies can deliver higher quality information and give more visibility into 1 IDC, Carl W. Olofson, “IDC Market Analysis Report, Worldwide Embedded DBMS 2010-2013 Forecast and 2008 Vendor Shares,” IDC #221438E, January 2010.


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outsourced processes and data, so project sponsors can confidently delegate parts of their development while maintaining overall management control. Generally, advances in technology are critical to streamlining product development processes in the life sciences market. In fact, such improvements can optimize operations during each phase of bringing a drug or device to market and then help ensure its ongoing successful use. Technology improvements can assist in accomplishing the following:

• Accelerate and optimize discovery and product development—Scientists need to gather, rationalize, and share highly distributed research data and perform streamlined, data-driven analysis in order to identify the best product candidates.

• Improve operational efficiencies and outcomes in clinical trial management—Researchers must optimize processes for trial management and clinical data collection and analysis to improve the quality and efficiency of the product pipeline and shorten time to market.

• Reduce manufacturing risk and maintain product quality—Life sciences manufacturers continually strive to ensure product quality, optimize resources, reduce waste, and control inventory. To meet regulatory compliance mandates, they must also ensure information integrity and security by enforcing controlled, encrypted, and audited access to data. The most efficient means of doing this is to develop validated manufacturing processes that incorporate quality from beginning to end.

• Protect the integrity of the supply chain—Distributors, wholesalers, and retailers need to work with manufacturers to ensure counterfeit items don’t enter the supply chain at any point. Products are “tracked and traced” through the supply chain to the eventual end user to maintain product quality and patient safety.


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Embed Oracle Technologies for Optimized Results

To address industry challenges, life sciences companies need effective solutions to support data-generation devices and solutions that reside on the “edge” of the enterprise. Embedded technologies from Oracle provide state-of-the art data management functionality that is self-installing, self-configuring, and self-managing—making it ideal for lean deployments at the edge of the enterprise, where IT support is often not available. Oracle technology can be embedded in OEM hardware devices, ISV applications, and into a systems environment to connect edge devices and solutions with systems throughout the enterprise. The Oracle software is invisible to the user, but enables end-to-end, “always on” solutions that cost effectively secure and store data and fill the need for a common development infrastructure that is standards-based, and easy to deploy, manage, and maintain.

Build or Buy?

There is simply no reason for you to build embedded data management capability when there is a range of proven commercial-off-the-shelf technology products available from Oracle. Many life sciences products embed databases—from enterprise or internet applications to small consumer devices or large-scale industrial equipment—each with different technical requirements. A small footprint may be required, or superior speed or scalability, and in other cases robust support of multiple datatypes.

Alone among database technology vendors, Oracle can provide ISV and OEM partners the choice and flexibility of a “one-stop shop,” from the edge of the enterprise to the back of the data center. By embedding Oracle technology in your life sciences solutions, you can incorporate databases, middleware, service orchestration and identity management tools, application servers, and messaging into one bundled solution. You can also synchronize an Oracle database product inside the device with Oracle Database technologies residing on your customer’s application servers and data warehouse, where they can address encryption, expanded security or regulatory compliance requirements, and management of databases and middleware alike.

Oracle embedded database and middleware technologies can greatly reduce engineering cycle time, cost, and risk, letting you focus scarce resources on your solution and its unique value-add instead of

Why embed Oracle products? • Complete, turnkey solution—Reduce dependencies on external components

• Faster, cheaper deployment—Install and configure all components automatically

• Unattended operation—Run without human administration

• Low total cost of ownership—Lower implementation, licensing, hardware, and administration costs

• “One-stop” support—Deliver superior support to your customer by becoming their single point of contact

• Competitive pricing—Embedded Oracle licensing provides flexible models for OEMs and ISVs


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the underlying data management. Your products more easily meet enterprise database requirements over the long term, reducing support costs and boosting revenue flows.

Oracle Is #1 in Life Sciences

IDC Health Insights ranked Oracle as the #1 vendor for enterprise life sciences software applications, easily topping the list with US$60 million more in software license revenue than second place SAP2. IDC surveyed enterprise solutions, including many that directly impact life sciences product development and manufacturing success, such as business intelligence/analytics, clinical software, manufacturing, supply chain management, product lifecycle management, and research and development informatics and discovery platforms.

Oracle’s commitment to the life sciences industry has generated a large installed customer base—most likely including many of your target customers. Embedding Oracle technology into your solution gives you a competitive edge because these companies already count on Oracle applications to help them run their businesses. Moreover, your solutions can more easily integrate with your customers’ existing systems when many of them are supported by Oracle products.

Benefits of Partnering with Oracle

In addition to market-leading products, Oracle offers partners additional benefits. During development, Oracle provides world-class engineering assistance to ensure that your engineers can seamlessly integrate Oracle technology into your products. After you deploy, you will be able to deliver superior support to your customers by being their single point of contact, while Oracle supports you with global, 24/7 support in local languages. The cost for this support will be far lower than maintaining your own homegrown solution, and you also avoid the risks of maintaining your own support staff. Additionally, you benefit from Oracle’s continued engineering investment to add new product features and enhancements.

Partnering with Oracle also helps you go to market. Oracle has an ecosystem of more than 275,000 customers and 17,000 partners, and Oracle PartnerNetwork offers a number of programs to help you reach that base. In addition, the strength of the Oracle brand can increase your customers’ confidence in your product, which can eliminate concerns and ease adoption.

Oracle’s product and partner strategies offer flexible pricing, including high volume discounts, royalty models, buyouts, list price discounts, bundle discounts, and more to help lower your cost of goods sold.

2 IDC Health Insights, Eric Newmark and Alan S. Louie, PhD, “Health Industry Insights: Worldwide Life Science IT Spending Guide: Perspective,” Health Industry Insights #HI218060, May 2009.


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Finally, Oracle’s financial strength and integrated, innovative technology backed by the power of the Oracle brand helps reduce your time to market, moving you ahead of the competition.

Address Common Problems Life Sciences Companies Face

Life sciences organizations across the industry use discovery, development, manufacturing, and distribution processes that are data-intensive, sensitive to market timing, and subject to strict regulatory compliance. Increased outsourcing and the global nature of the life sciences industry means that many edge devices must be supported, however your customers still need to maintain visibility into these critical processes. By embedding Oracle technology, you can deliver software and devices that

• Use scalable technology to manage large data volumes

• Integrate unstructured datatypes

• Integrate silos of information from the edge to the enterprise

• Collaborate to enhance product development

• Improve business insight and reporting

• Increase information security and ensure regulatory compliance

Use Scalable Technology to Manage Large Data Volumes

Life sciences data is growing rapidly and often scales to many terabytes. In organizations tackling genome-related projects, next-generation DNA sequencing platforms can fill a room, running 24/7. Additionally, the increasing use of digital imaging, audio/video, and 3-D visualization—which generate terabytes or even petabytes of data that need to be retained for long validation and product life cycles—indicate that data volumes in life sciences will continue to expand. Therefore, in life sciences applications it is critical that technology has the ability to scale as data volumes grow, however, high performance and availability must be maintained as well.

Support High Performance Computing Grids

Oracle Database 11g has been designed to scale to exabytes of data and offers unbreakable reliability and enhanced manageability features, many of which are part of Oracle’s unique enterprise grid architecture. Oracle Real Application Clusters (Oracle RAC) with Oracle Database 11g provides the

“With a full slate of database infrastructure components, Oracle is central to helping us bring next-generation bioinformatics

solutions to our customers, especially those who are implementing server consolidation and virtualization, or using a rack-based

architecture, or expanding their reliance on Web services. All are effective strategies for our customers, and Oracle helps us to

help them in pursuing those strategies.”

—John Swallow, Waters Corporation


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foundation for grid computing by supporting the deployment of a single database across a cluster of servers. Embedding Oracle database technologies into your device or application enables them to be integrated into an enterprise grid computing architecture.

An in-memory data grid offers a more-efficient way to analyze large volumes of data—multiple servers work together to manage information and related operations such as computations in a distributed environment. These technologies protect data and optimize performance by automatically mirroring and balancing data across all available storage devices, increasing access and computing throughout the organization. Database maintenance and synchronization is coordinated across local and remote servers for rapid recovery from disaster or site failure. High-performance computing grids are commonly used to power processes that involve a massive amount of data and require huge computational resources, for example, the complex analysis of genomic DNA studies or preclinical drug-research data, or meta-analysis of pooled clinical trial data.

The Oracle grid computing architecture delivers powerful data management capabilities, unbeatable fault tolerance and performance, 24/7 availability, and it scales to manage data volumes of many terabytes. It lowers total cost of ownership by enabling the use of commodity-grade server and storage devices to optimize resource utilization while still supporting a highly reliable, robust database operations environment.

Figure 1. Oracle grid computing architecture can be used to efficiently manage operations in the distributed environment typically employed in life sciences companies.

One example of the advantages a scalable data processing system for drug development offers can be seen in a pharmaceutical laboratory simultaneously running iterative tests against multiple reagents on multiple liquid chromatographs. These tests generate large volumes of data that must be aggregated and stored. Considering that each liquid chromatograph generates 400 gigabytes of data per day and may run seven days per week, the lab needs an effective way to scale its data collection and aggregation capabilities.


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To meet this need, the solution can provide the “black box” with embedded Oracle technology that will collect the chromatograph data and—through a Web service—make it available to various applications and analysts, anywhere, in a highly automated, secure, and cost-effective fashion.

Integrate Unstructured Datatypes

The vast majority of the information used by life sciences organizations is referred to as unstructured data. This information does not easily conform to standard data structures (such as rows and columns) and without human or machine-based interpretation, it is difficult to understand the data content and context. Common examples are documents, multimedia content, location information, medical imagery, and Web content such as HTML.

With the release of Oracle Database 11g, Oracle delivers features that bring the benefits of a high-performance relational database to the problem of storing vast quantities of unstructured data. Oracle SecureFiles combines the security, scalability, and reliability of a relational database with the speed of a file system to provide fast access to content traditionally stored in a separate file system. With access times equal to, or faster than, file systems on the same hardware, it lowers costs by removing the need for specialized hardware. By moving unstructured data into databases, your customers can better track and secure important data that is currently spread around their enterprise. Oracle Database 11g delivers unique advantages specific to the management of unstructured datatypes.

Store Information in Specialized Network Data Models

Oracle Spatial Network Data Model enables data to be stored in a relational architecture, but to be modeled as if it were in a graph representation, that is, a series of nodes and links. Analytical functions available with the network data model feature include shortest path, all paths, within cost, nearest neighbors, and minimum-cost-spanning tree. It is possible to add constraints to the analytics that include path cost, path length, and minimum bounding rectangle. There are a number of uses for network data models in the life sciences, including managing metabolic pathways, protein-protein interaction maps, drug safety determination, medical imaging, and text mining.

Manage Multimedia Data

Life sciences data is often best stored as images, for example, gene sequence data, histopathology sections, electrophoresis gels, EKGs, and CT and MRI scans. Movies are also becoming more

“Genomics presents researchers enormous challenges in terms of data volume, collaboration, and integration. By handling

diverse datatypes and data objects; by supporting clustering, version control, and enhanced security; and by enabling us to take

full advantage of service-oriented architecture, Oracle technologies provide an excellent way to meet the challenges of

genomics.”

—Dan Conway, CLC bio


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common for applications such as monitoring cell growth or animal behavior. Oracle Multimedia, a feature of Oracle Database 11g, enables the management of audio, video, and image data by the Oracle Database. It helps your customers manage large volumes of multimedia content by automatically associating the correct metadata with the media, indexing the content for search and retrieval, and efficiently delivering the multimedia content to end users. Oracle Multimedia extends the reliability, availability, and data management capabilities of Oracle Database 11g to multimedia content, as well as addresses security, access control, and regulatory compliance needs.

Figure 2. Oracle Multimedia manages audio, video, and image data.

Using Oracle Multimedia, you can manage complex multimedia datatypes as if they were “normal” datatypes, removing the need to develop sophisticated tools to get the greatest use from multimedia data. It also provides you with all the functionalities available to a “normal” datatype—backups, compression, encryption, auditing, and more. While Oracle Multimedia makes it possible for metadata and media to be stored together within the Oracle Database, it also provides for storage and retrieval of the media content outside the database. This increases storage flexibility by integrating archival storage into the business process.

Oracle Multimedia provides the infrastructure for a solution that is centered on the needs of your customers. Using partner solutions on this infrastructure platform, life sciences companies have direct, immediate, cost-effective access to clinical research image data. They can consistently apply research standards, enhancing data quality and increasing the transparency and accountability of external contract organizations. Multiple workflows are supported from one centralized store, increasing control over the data for improved review, reporting, analysis, and reanalysis.

Offer Built-In Support for DICOM Format

Digital Imaging and Communications in Medicine (DICOM) is the format universally recognized as the standard for medical imaging. Medical image data is an important diagnostic tool and is used throughout the product development process, often serving as a clinical trial endpoint. Oracle Multimedia provides rich support for the DICOM format, making it possible to build large repositories of DICOM content that are managed and secured using powerful Oracle Database tools. When DICOM content is stored in an Oracle Database, the database can guarantee that unauthorized access to the content is forbidden. DICOM content can also be compressed to reduce data volumes and encrypted to enforce security compliance. Oracle Database provides anonymity services directly in the


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database, so it enforces role-based access to a DICOM-format medical archive to ensure patient privacy, regardless of the application used to access the objects in the archive.

Deliver a “Real-World” Perspective with RFID and Sensor Data

Using embedded Oracle technology, your application or device can capture, analyze, and respond to data from sensor devices such as radio frequency identification (RFID), and those for location, temperature, and humidity. This sensor data gives your customers the ability to connect the physical world to the information world, providing greater visibility into their assets, enabling better operational decisions, and helping them get closer to becoming a real-time enterprise.

Oracle's mature, proven embedded technology—including Oracle Database, Oracle Fusion Middleware, and Oracle Enterprise Manager—power Oracle RFID and sensor-based services and let companies quickly and easily integrate sensor-based information into their enterprise systems such as manufacturing, warehouse management, and supply chain applications. These services also enable event messages to invoke other applications or initiate business processes. This event-driven architecture lets your customers create new business rules and enterprisewide workflows for automatically, consistently, and rigorously monitoring and controlling processes throughout their organization.

Additionally, embedded Oracle RFID and sensor-based services have the flexibility to collect RFID messages from hardware devices that use different RFID event formats and filter these messages to detect and eliminate those that are erroneous or duplicates. With Oracle embedded products, you can deliver a hardware-agnostic platform that protects your customers’ hardware investments from reader updates or changes.

Control Manufacturing Processes

Process and workflow automation using sensor-based data helps your life sciences customers build quality directly into their manufacturing processes. They can rely less on manual checks and more on built-in checks and sampling that can be used to monitor and control operations—including automated adjustments in manufacturing processes based on sensor data and other information from testing devices. By combining RFID-generated events with real-time notification systems, operations personnel can more quickly respond to manufacturing problems, minimizing their impact.

Automated controls allow manufacturers to enforce complex business rules such as those that require materials to undergo specific quality tests before they reach customers. Such controls reduce ongoing complexity, redundancy, potential for operator error, and materials waste. Moreover, sensor data can be captured in the embedded database where it can be analyzed to improve quality and audited by regulatory agencies.

Protect the Supply Chain

Sensor-based technologies can also help your customers decrease the chances of counterfeit or reduced-efficacy items entering the supply chain.


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Figure 3. Sensor-based technologies can verify the authenticity and protect the quality of products by creating electronic histories (ePedigrees) for each item.

Your solution can use these technologies to store information about a drug, device, or combination product including its name, lot number, quantity, dosage, form and strength, transaction date(s), container size, expiration date, shipping information, and more.

In addition, the environmental conditions such as temperature and humidity encountered by the product as it travelled through the supply chain can be documented to show these factors remained within acceptable ranges to protect product efficacy. This degree of documentation and product quality protection is especially important during clinical trials, and this sensor-based business process can be used to ensure all clinical study drug and materials are handled appropriately.

Also, if the drug or device is returned to the manufacturer or wholesaler, that can be documented in the electronic history. By tracking items at a very granular level, the costs and negative brand impact of product recalls can be significantly decreased by allowing only the affected product to be recalled and not having to implement a massive recall because the problem cannot be isolated to a lower level.

Improve Supply Chain Efficiency

The use of ePedigrees benefits drug and device manufacturers, distributors, wholesalers, retailers, and consumers. Fortunately, the technology not only helps these organizations ensure product safety and comply with legislation, but can also result in cost savings and business efficiencies throughout the supply chain. RFID technologies can be used to increase shipment accuracy, improve productivity in shipping and receiving, and lower labor costs. These technologies can also be used to increase the speed and accuracy of inventory accounting, reduce out-of-stock and out-of-date products, and deter theft.

Integrate Silos of Information from the Edge to the Enterprise

With possibly hundreds of specialized instruments and solutions for various analyses used in the product development process, data integration between research applications, legacy systems, laboratory devices, and regulatory compliance engines is becoming a necessity for efficient operations. Silos of non-standardized data scattered across multiple databases make it difficult to scale up as new instruments are installed and can lead to the inefficient use of capital-intensive resources.


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With Oracle technology embedded in your solutions, you can meet your customers’ needs to access, integrate, manage, query, mine, and securely share the valuable information hidden in their genomic, proteomic, chemical, clinical trial, and other data. Effective use of this information can help accelerate the discovery pipeline and get the most promising compounds and medical devices headed toward clinical trials.

Oracle solutions can manage distributed data very effectively, with excellent performance and without compromising the access control of the data. And, with Oracle’s open standards-based data formats, your customers gain greater flexibility for more-productive data management, analysis, and data sharing across the enterprise.

The Power of Service-Oriented Architectures

Embedding Oracle technology in your devices or solutions gives your customers the data integration advantages of a service-oriented-architecture (SOA). SOAs are based on loosely coupled services with interfaces that are independent of the implementation. You can build, use, and reuse services according to changing business needs, as well as easily integrate across dissimilar platforms. SOA standards allow new applications to share a common model of development, maintenance, support, and staffing expertise.

For life sciences developers, a big advantage of SOA is the comparative ease of delivering bioinformatics and other software solutions as Web services. With no need to install code on end-user workstations, workstation requirements are less robust and stringent, which effectively broadens the customer base that can access the information. SOAs also can help developers consolidate multiple data repositories and reporting tools into a single XML-formatted repository and a single set of tools. This enables a common framework model that can be used across a customer’s applications, laboratory, and entire business environment.

Through targeted programs, Oracle works directly with partners to provide an embedded SOA “black box” solution for managing data aggregation, flows, sharing, and retention from larger deployments of analytical instrumentation. The Oracle components of this solution provide an out-of-the-box infrastructure (database, middleware, and Web services) that addresses ease of use, workflow, platform consolidation, regulatory compliance issues, and other concerns that are particularly pressing in large-scale life sciences deployments.

SOAs Improve Efficiency of Patient-Reported Data Collection

Patient-reported outcomes are growing in importance and prevalence in all aspects of drug development, however, paper-based collection of this data is often inefficient and cumbersome, discouraging patient participation. Collecting this information using a PDA, other electronic device, or through a Web portal is often easier and more efficient for patients. These methods also deliver more-accurate data with better process visibility, improving the data analysis and submission processes.


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Even for large clinical trials, all patients can be given a device that records their vital signs and medication dosages, and that boosts compliance by reminding them when to take their study medication. Collected patient information can be transmitted to Oracle database technology embedded in mobile devices and then automatically synchronized with the primary clinical database according to predefined rules. In addition, applications built to run on Oracle Application Server can give clinicians and researchers a consolidated view of this patient data using Web access—allowing them to better manage clinical trials.

This schema uses embedded Oracle technology to implement a SOA-based infrastructure that is flexible, scalable, and reliable. It can be expanded in many ways, such as to include clinical trial remote data entry at research sites using tablet or laptop computers, or to capture questionnaire data from electronic patient diaries. This data can be stored in a centralized data warehouse powered by Oracle Database software and can also be integrated with digital lab data, imaging data, and other data components of clinical trials.

Deliver Affordable Oracle Database Benefits to a Wide Range of Customers

You can offer your customers the benefits of Oracle Database without requiring them to purchase a database license or provide database support by embedding Oracle Database into your application. Even if they use older equipment and legacy systems, your application can provide robust database services with an embedded Oracle Database. This lets you increase market penetration by enabling you to target a wider range of customer environments.

For instance, Data Innovations has developed a clinical laboratory management system application with an embedded Oracle Database that supports sample data integrity, automated data replication, and disaster recovery—significantly improving customer operations and counterbalancing the use of older or less reliable equipment. It provides an affordable, turnkey solution for smaller clinics and laboratories that automatically protects against data failures, errors, and corruptions, as well as ensures high availability of the system.

Collaborate to Enhance Product Development

In life sciences communities, researchers often need to collaborate and share information with other researchers inside and outside an organization. This not only creates challenges in terms of physically sharing data, but also presents many security issues.

“Oracle’s embedded software licensing structure enables partners to leverage Oracle technology to bring the benefits of world-

class solutions to companies of all sizes, without the financial risk of up-front investment.”

—Bob Rothstein, Data Innovations Europe


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Oracle Database 11g, Oracle Application Server, and Oracle Collaboration Suite provide rich collaboration and security features that greatly facilitate collaboration among researchers and data-sharing between heterogeneous applications. Oracle Database support for secure collaboration includes:

• Oracle Virtual Private Database to physically separate data within one database, by user or by customer, dependent on the configuration

• Oracle Label Security to enforce label-based access control in the Oracle Database

• Oracle Audit Vault to proactively detect threats, reduce costs, and secure audit data

• Oracle Workflow to automatically process and route any type of information, according to business rules specified, to any person or system inside or outside an enterprise

Improve Business Insight and Reporting

In order to gain the greatest benefit from the data stored throughout their enterprise, life sciences organizations need business intelligence (BI) products that inform all their processes: operational, financial, clinical, and regulatory. Embedded Oracle technology can help your customers fast-track their product management efforts by taking advantage of a highly scalable BI platform that powers analysis tools and reporting applications and supports easy, secure distribution of results. Built on a foundation of Oracle database and middleware technology, this platform also supports tools to integrate data and documents from multiple, disparate sources across an organization, including unstructured file formats. These capabilities help turn previously “unsearchable” data into information your customers can use.

Using a familiar Web interface, users can take advantage of a wide range of built-in analysis capabilities, including query and reporting, statistical functions, regular expression searches, data mining, text mining, online analytical processing, and the ability to create custom analytical functions. They can track and follow data over time by creating dynamic reports that can be transformed into multiple formats such as Microsoft Office, PDF, XML, and more.

For example, life sciences manufacturers can run real-time analyses to yield business insights that help improve product quality and operating efficiency, as well as streamline compliance. Advanced analytics let them conduct quality analysis, risk assessments, yield analysis, on-time production tracking, cost comparisons by job, and comparisons of manufacturing plans and efficiencies between sites, to name just a few options.

“InforSense’s technology is tightly coupled with Oracle technology. We welcome the analytics Oracle Database 11g offers, such

as decision trees, providing our joint customers with a comprehensive choice of in-database processing capabilities for

enterprisewide integrative analytics.”

—Yike Guo, InforSense


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Selected information is easily distributed by sending colleagues or regulators formatted reports using e-mail. Additionally, insight can be securely delivered across the enterprise using presentation methods that are easy to access and understand, such as Web portals, alerts, and dashboards. Moreover, because Oracle embedded technologies are at the core of your solution, raw data and reports can be archived for retention and regulatory purposes using Oracle Database tools.

Increase Information Security and Ensure Regulatory Compliance

Regulatory compliance is one of the principal factors influencing the evolution of product development in the life sciences market. Your customers are acutely aware that the benefits of robust data protection and regulatory compliance far outweigh the costs of government inquiry, public scrutiny, and litigation. They need solutions for storing huge volumes of data for decades or more, in addition to security, integrity, and access technologies that can make the data readily available for auditing or reporting to regulatory agencies.

Embedding Oracle technologies into your solutions helps you deliver best-of-breed applications to address regulatory compliance requirements, while also providing a high performance, scalable solution. Compliance becomes non-intrusive, a natural outcome of the product pipeline process, as Oracle Database technologies ensure that customers can control access to data, audit changes, safeguard security, and retain and retrieve data as needed.

For example, during the manufacturing process, it is difficult to establish, deploy, and document the corrective and preventative actions required by regulators without detailed information regarding the source of the problems—information such as the time and date of the error, the applicable manufacturing phase, facts about the incident or observation, the level of criticality, required follow-up, and the operators and supervisors involved. This information can be costly and time-consuming to handle manually, but it is essential to improve quality and meet regulatory requirements. By using an embedded database in a device (HPLC, spectrometer, blood analyzer, lab or clinical workstation, manufacturing sensors, and more), your application can store rich metadata that captures this necessary information and secures the data at its source.

Meet Global Data Security Requirements

Increasingly stringent regulations and requirements concerning data privacy, integrity, and traceability must be met to avoid risking the viability of an entire business. To address the unique challenges of secure data control with a complete audit trail, Oracle Database technology offers a sophisticated range of security and auditing features that comply with various global security standards.

Oracle pioneered many of the database security technologies in widespread use today, including the first network encryption, the first row-level security, the first fine-grained auditing, and the first transparent data encryption. For the security levels required specifically in the life sciences, Oracle Database technologies deliver fine-grained access control, user management, and user authentication. They also support the auditing, querying, and reporting of metadata changes. Oracle Database Vault provides flexible, transparent, and adaptable security controls that require no application changes.


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Oracle Total Recall automatically tracks every change made to the data stored inside the database and maintains a secure, efficient and easily accessible archive of historical data. These Oracle Database features help you automate audit collection, monitoring, and reporting processes—turning audit data into a key security resource.

Implement Better Access and Identity Management

The safety and security of sensitive data and intellectual property is also a major concern affecting the life sciences industry. With today's greater demands for data security, organizations have realized additional benefits from deploying access management, especially in areas such as compliance and federation. With the advent of the Sarbanes-Oxley Act, capabilities like Web-access management have become the preferred technology for enforcing certain requirements. By embedding Oracle Database technologies, you deliver access control and identity management systems that enable organizations to enforce access and provide a detailed audit trail to show auditors exactly what has occurred with the data at all times.

Pharmaceutical giant Pfizer is a good example of a company that’s expanding its use of access management to meet an ever-broadening set of IT challenges and business opportunities. The goal is to treat authentication as an infrastructure service, so that each application can require the proper form of authentication from users. This structure is important because the company’s drug research and development efforts include both applications that are low sensitivity, with a low risk of information disclosure and loss of data integrity, and high sensitivity, with strict requirements for absolute data integrity and access control. The company leveraged Oracle Database features to build a unified—and centralized—Web portal for more-efficient internal and external access control.

Conclusion

Solutions with embedded database and middleware technology are ideally suited to deployment at the “edge” of the life sciences enterprise, where there may be little to no IT support. Additionally, because the data management piece is not accessible to the end user, it does not need to be validated separately from the larger solution. This can potentially trim a year or more from time-to-market when extensive software validation is required. End-user inaccessibility also gives you more control over support costs and helps you guarantee service-level agreements with your customers.

“We use Oracle Access Manager and the Oracle Virtual Directory products for our identity and access management

infrastructure. We've worked closely with Oracle over the past two years to develop a solution that enables individual users to

select the level of authentication that's right for the task they're trying to do.”

—William Barnes, Pfizer


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Embedding Oracle technology allows you to provide your customers with low-maintenance solutions that let them manage the configuration and diagnostics of millions of networked devices, collect and store instrument test results, manage high volumes of data, and securely capture rich metadata at the device level. Your solutions can deliver high availability and scalability, detect unauthorized activity through audit capabilities, balance workload across servers, and integrate multiple systems into a single platform. These benefits help your customers reduce support costs without sacrificing performance.

The simple fact is robust data management is hard. Outstanding performance—especially under unpredictable workloads—requires long-term, continuous analysis and tuning. Building highly available, reliable systems that recover from problems automatically requires deep expertise and years of real-life field deployments. Oracle Embedded was created to support Oracle’s industry-leading set of embeddable products that can be used to address an extremely wide range of requirements. And these products are delivered with comprehensive product and support pricing that meets any competitive business model. As Oracle partners, you benefit from a single, global vendor experience—with one vendor, one support system, one contract, one long-term relationship.

Oracle embedded technology has been proven through millions of mission-critical deployments throughout the life sciences industry and beyond.

20 of the top 20 pharmaceutical companies run Oracle Applications

10 of the top 10 contract research organizations run Oracle Applications

20 of the top 20 medical device companies run Oracle Applications


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Appendix

A Sample Integrated Data Processing Model for Drug Discovery

Research and development is typically very process- and workflow-oriented with data movement that is extremely complicated. A typical drug discovery system has eight core processes that evolve around collecting, tracking, correlating, integrating, and archiving data across multiple inputs and systems. To add further strain, regulatory compliance uses rules that change rapidly; requires advanced analytical techniques; and requires long-term, stateful data access for more than seven years.

The standards-based components and scalability offered using Oracle embedded products in a configuration such as that illustrated in Figure 4 support the requirements of your process, as well as flowing through to end-product solutions your customers can count on.

Figure 4. Oracle embedded technology components can help you meet the functional, technical, and business requirements of each stage in the drug discovery and development process.


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TABLE 1. ORACLE EMBEDDED TECHNOLOGY USE AT EACH STAGE OF THE DRUG DISCOVERY AND DEVELOPMENT PROCESS

Data Input: Automatically capture and validate data generated from clinical workstations, office applications, mass spectrum

equipment, lab instruments, drug studies and more; catalog results and methods with no manual intervention by analysts. With Oracle

solutions you can store sample data directly in lab equipment and workstations and within minutes move changes to the “Sample Data

Analysis Layer.” Storing data locally provides a metadata layer to validate sample quality, improve overall sample tracking performance,

and improve the transitory state between the data input tier and sample quality analysis. Samples, orders and results are securely

tracked at all times.

Sample Data Analysis: The sample data analysis layer uses Oracle WebLogic to automatically capture, analyze, validate, and format

results for collecting and storing large amounts of data. It also provides a common development framework to reduce development

time, eliminate data silos, and convert sample data to images or XML documents and store them in the data repository. Oracle

Coherence improves the performance of long-running analytical routines and Oracle TimesTen boosts the performance of data

characterization processes.

Interoperability is achieved using Oracle SOA Suite to provide a standards-based data exchange mechanism to the application layer.

Advanced analytics give researchers the tools to evaluate testing results and make ad-hoc modifications to sample analysis processes.

Thus they can validate product safety and efficacy and produce meaningful results without extensive re-engineering.

Application Layer: The application layer provides end-user Web access to view process results, drug reports, discovery and clinical

analyses, and more using internet information server technology. Oracle Coherence is used to manage application session-state

information for long-running transactions.

Aggregation Layer: Oracle WebLogic and Oracle SOA Suite perform additional data processing, data correlation, and data integration.

In addition, these products host highly scalable business logic for further analysis of samples, move completed samples into workflow,

interface with external systems, and provide required data for regulatory compliance. Oracle Data Integration Suite and Oracle Tuxedo

provide the ability to collect data from external systems like SAP, CRM and ERP systems, legacy applications, and more. Oracle

Outside In is used to create search filters for indexing and organizing unstructured content; capture printed files from any application,

including reports generated for scientific review; and convert spreadsheets, reports, images, and drawings into standard formats such

as PDF or EMF. Oracle TimesTen allows faster data access.

Data Repository: The core foundation for a drug discovery solution framework is an embedded Oracle Database 11g Enterprise

Edition database including options such as Oracle Real Application Clusters, Oracle Active Data Guard, Oracle Secure Backup, and

Oracle Partitions. Oracle Database 11g is used to store massive amounts of data, provide a central repository for all samples, store

analytical regressions, manage work lists, and provide a consolidated BI repository. Oracle Database 11g also provides embeddable,

built-in management tools for the administration, backup/recovery, and archiving tasks needed to comply with regulations.

External Data Systems: These are systems outside the lab environment that are required for integration purposes.

Regulatory Compliance: Compliance data is kept up-to-date by directly extracting information using aggregation layer connectors

from Oracle SOA Suite or Oracle Tuxedo. Security of shared services is provided by the Web Services Manager in Oracle SOA Suite

11g and authentication is provided by Oracle Directory Services (LDAP or Active Directory).

Business Analytics: Oracle Business Intelligence Suite Enterprise Edition is used for online Web-based analytical reporting,

forecasting, and dashboards. It also provides the ability to create and e-mail PDF or EMF reporting files. It can be integrated with data

mining and querying options inside the database to automatically sift through data and find hidden patterns, discover new insights,

make analytical predictions, and answer complex questions.

Embedding Oracle Technologies in Life Sciences Solutions May 2010 Oracle Corporation World Headquarters 500 Oracle Parkway Redwood Shores, CA 94065 U.S.A. Worldwide Inquiries: Phone: +1.650.506.7000 Fax: +1.650.506.7200 oracle.com

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