Accelerating Time to Market with the Power of Cloud-Based Integration

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1 Accelerating Time to Market with the Power of Cloud-Based Integration

2 Now more than ever before, flat revenue and increased development costs have made time-to-market a crucial factor in profitability for the pharmaceutical and biotech industries. Fortunately, new protocols and technologies are growing at a rapid pace, making this a time of change and opportunity in the life sciences industry. A white paper for pharmaceutical and biotech industries Now more than ever before, flat revenue and increased development costs have made time-to-market a crucial factor in profitability for the pharmaceutical and biotech industries. Just as companies are starting to look for ways to speed product launches, however, increased regulation has made it more difficult to get drugs and devices through the review process. Fortunately, new protocols and technologies are also growing at a rapid pace, making this a time of both change and opportunity in the life sciences industry. Thanks to initiatives such as the Biomedical Research Integrated Domain Group (BRIDG), companies today have more access to data than in the past. Other recent advances in patient recruitment and clinical trial management such as globalization and adaptive trials are giving the industry new solutions to improve speed to market. Yet at the same time, mergers, acquisitions and outsourcing are improving operational efficiencies but creating new obstacles because of decentralized data. The challenge with all of these new opportunities lies in how quickly and efficiently companies can analyze clinical data from different sources to make key business decisions. With disparate information housed in silos, time to market can be slowed by inaccurate data or scalability issues, as well as timeintensive manual data entry and rework. All of these trends require a new thought process around building data management platforms that can quickly integrate, aggregate and harmonize information. Legacy systems do not have these advanced capabilities and developing new systems internally typically requires extensive investment in technology and resources. Internal IT staff can seldom keep up with the demands of new compliance and business requirements while also facing pressures to develop leading-edge data infrastructures. Outmoded processes can t keep pace with pharmaceutical innovation While current data management techniques have made progress, they face significant challenges when it comes to true integration and collaboration. These challenges will become even more apparent as trends and innovations within the industry continue to shape the way pharmaceutical and biotech companies do business. For example, traditional point-to-point and ad hoc integration can lead to problems with data integrity and require manual steps to share data. Applications often involved include Electronic Data Capture (EDC), Clinical Data Management Systems (CDMS), Clinical Trial Management Systems (CTMS), Clinical Data Repositories (CDR) and Statistical Analysis System (SAS) Analytics.

3 In addition, many platforms have difficulty with collaboration. Three common approaches traditional integration, extended integration and external integration each offer distinct advantages and disadvantages based on their application and use: Traditional integration typically is used with internally managed trials only, since collaboration with outside entities is limited. Extended integration via the web or through a virtual private network (VPN) allows for some external sharing of data through the employment of security measures that extend applications to partners. However, lab data is still an external integration issue, and scalability can be difficult with this approach. Internal hosting costs can be high, and this is not a core competency for most internal IT resources. External integration allows companies to receive incremental or final data sets from CROs, labs and other entities, but it is essentially a custom mapping and migration exercise. Scalability of applications, especially involving global business units, can be difficult and hosting costs with this method also can be high. Cloud-based data management supports the future of life sciences As the industry continues to struggle with the limitations of traditional data management approaches, advances in cloud-based technology have presented a unique solution for the future. Other industries such as financial services, consumer packaged goods and retail have capitalized on cloud-based infrastructure to support the management of vast amounts of data for global operations and communications. These best practices have allowed for the development of systems that support sophisticated data integration through a Platform as a Service (PaaS) model. To understand data integration through a Platform as a Service model, you must first examine the different aspects or layers of the cloud itself. Cloud technology is perhaps best known for supporting Infrastructure as a Service (IaaS), where companies pay for space and usage of hardware, CPU space, memory and firewalls. This is truly the bottom layer of the cloud, which allows companies to expand and reduce their need for infrastructure with ease. As the industry continues to struggle with the limitations of traditional data management approaches, advances in cloud-based technology have presented a unique solution for the future. Sophisticated data integration through a Platform as a Service (Paas) model acts as the brain and nervous system, where the real strategic thinking happens inside the cloud. These are the tools, capabilities and services that solve complex business problems.

4 In the middle layer of the cloud is Platform as a Service (PaaS). Although less familiar to most companies, PaaS is critical to any successful interaction with the cloud. Components of PaaS help take client data and transform it into useful and usable information. At the outermost layer of the cloud lies Software as a Service (SaaS), which hosts applications such as dashboards and charting programs created to help users consume information. Familiar uses for SaaS applications include human resource packages, sales automation software and stock option applications. If you think of the cloud as a human body, SaaS would comprise the outward appearance the skin. These are the applications you see. IaaS in this analogy would consist of the skeleton; it is the structure that holds everything up. In the middle, the all-important PaaS would act as the brain and nervous system. This is where the real strategic thinking happens inside the cloud. These are the tools, capabilities and services that can solve complex business problems. PaaS includes services such as Integration as a Service, Data as a Service and Information as a Service. Designing a platform that creates actionable information Integration as a Service is an integration specialty that involves the ability to perform complex data integration in the cloud. This technology operates in the background of a company s IT systems, allowing organizations to achieve greater functionality and scalability. It is a cost-effective solution that allows large amounts of data to be transported and analyzed quickly, easily and intelligently with fewer dedicated internal resources required than with traditional methods. While the cloud itself provides a flexible and scalable environment for Integration as a Service, it is the design of the platform that is crucial for answering the pharmaceutical and biotech industries data integration challenges. To make information truly actionable and dynamic, a series of steps must take place to connect, integrate, aggregate, harmonize and monetize the data:. The answer to data integration challenges Connecting data consists of the ability to join disparate information technologies to send information back and forth. The different methods to exchange information include FTP, HTTP, SSH and others, but common protocols can enable connectivity among them. In the past, this connectivity required large expenditures for hardware, software and other infrastructure. Today s cloud-based technology allows for much more efficient and cost-effective methods. Integrating data is a function closely tied to connectivity. Instead of linking the physical IT plumbing, integration links the data to make sure that different interfaces, information and formats will work together seamlessly. This is a difficulty in traditional point-to-point integration and is a significant advantage to taking a cloud-based approach.

5 Aggregating data involves assembling it from various sources to support large volumes of information as well as enabling real-time access. Data aggregation, along with harmonization, provides the ability for analytics to identify operational trends quickly and easily. Harmonizing data is the most important step in the process of creating intelligent data. It involves transforming data into a common, usable format, normalizing it to minimize redundancy and dependency and then translating it to equitable semantic definitions. For example, proper translation knows that field names such as surname and last name are the same and it eliminates duplication. True harmonization is achieved when the similarities and differences in data sets are reconciled and actionable data emerges from considerable volumes of diverse information. Monetizing data is the process of using intelligent data to drive business activity. Translating complex data for productive use and transforming it into meaningful insight allows companies to monetize data by getting drugs and devices to market faster. By removing the burden of integration and data management from internal IT staff, those resources then are free to work on activities more directly related to market differentiation Cloud-based integration can turn vast amounts of data from clinical trials, the manufacturing process, point of service and point of sale into information that supports business decisions quickly and accurately. Outsourcing through the cloud means that scalability, streamlined data mapping, improved data quality and fast, flexible data management all can be obtained through one solution. In addition, when implemented correctly by an experienced IT partner, set-up and management should be a simple, seamless experience that requires limited investment in infrastructure. Ensuring data security in the cloud Even in the face of all these unique advantages, one question remains in the minds of many industry experts with regard to cloud-based data management security. That is understandable; when it comes to safeguarding clinical data, there is no margin for error. Cloud-based solutions can ensure data privacy and security as readily as other approaches by focusing on access control, security of stored data and security of data in transit. Access control involves guaranteeing that only the right users have access to specific data. To ensure that appropriate levels of control are granted, pharmaceutical and biotech companies should work with their vendors to develop service level agreements that govern specific access requirements up front. These agreements hold the vendor accountable and ensure more effective control. In addition, companies should choose a partner with experience serving the health and/or financial industries to ensure that they have experience in safeguarding highly sensitive information. Other industries such as banking have taken advantage of cloud-based technologies for years. There is no need for the pharmaceutical and biotech companies to reinvent the wheel. Instead, they should consider reproducing those best practices.

6 case study: Liaison Healthcare helps merck & co., solve issues with data flow in mega trials, enabling the leading pharmaceutical manufacturer to achieve greater efficiency within the clinical trial process Liaison Healthcare consistently engages with many of the largest pharmaceutical manufacturers to assist in increasing efficiency through data flow within the clinical trial process. Following is one case study that illustrates the advantages of the company s solution. business issue Merck s internal IT systems have typically been able to accommodate standard, small clinical data trials. However, a mega trial brought new challenges that the company s legacy processes and tools- including its datam-mapping tool - couldn t support. While even standard trials needed efficiency improvements in data flow processes, the sheer magnitude of the mega trial caused inconsistent data flow for analysis purposes. The mega trial utilized more than 50% of all clinical data being collected that year and the data flow problems caused delays in the start and completion of other clincial trials. This resulted in a drain on overall corporate performance. Merck was using a single map for all data that had to be deposited in the clinical data repository. Because of the scope of the mega trial, the map size was extraordinarily large. Merck was required to change the map every time there was a change in the study, regardless of how large or significant the change was. Frequent changes meant there were ongoing changes in the map, which prevented movement of data. Merck s Objectives In enlisting the help of Liaison Technologies, Merck established clear and specific project objectives: Reduce time Reduce the number of days required to flow clinical trial data used for analysis Streamline the data mapping process Implement a solution to streamline the mapping of key clinical trial data to standard formats Reduce costs Reduce costs by accelerating and streamlining processes and by efficiently using offshore resources Enhance data quality Implement a solution that would improve data integrity, reliability and completeness of the clinical data repository, the target system Achieve scalability Redesign the data flow process and technical mapping components making them scalable and high performing Position for cloud-based implementation Implement a solution that would not restrict them from taking advantage of cloud-based services in the future.

7 Cloud-based integration can turn vast amounts of data from clinical trials, the manufacturing process, point of service and point of sale into information that supports business decisions quickly and accurately. Outsourcing through the cloud means that scalability, streamlined data mapping, improved data quality and fast, flexible data management all can be obtained through on solution. The liaison healthcare solution Liaison analyzed the data flow problems and developed a solution based on Liaison s mapping platform. The recommended solution included: New processes - Design new map development, testing, and deployment processes to streamline and optimize map-development processes. More scalability - Design a hosted, scalable, run-time system capable of scaling to more than 200 clinical trials simultaneously Library of standard form-based data maps - Created a library of standard form-based maps that could be used repeatedly, from one trial to another, which enabled data flow in a more efficient and consistent manner Training -Train Merck and their offshore contract research organization (CRO), Accenture, in how to use the new Contivo VMS solution. As the pharmaceutical and biotech industries continue to face new trends and challenges that hasten the tempo of business, innovation has become the most important precursor to profitability. It is only through rapid integration and interpretation of intelligent data that business decisions can keep up with this accelerated process. The results: improved efficiency, flexibility, simplicity and scalability Based on the success of a six-month pilot of Liaison s solution, Merck decided to implement the solution for interface mapping for all future clinical trials. Since then, Merck has begun to see improvements in the data flow segments of its clinical trial process and is working with Liaison to gain the following business efficiencies as a result of their efforts: Accelerated data flow processes Using Liaison s mapping solution, Merck now has the capability to create maps more efficiently, reducing the average map development process time. Another byproduct of this is that offshore resources are utilized more efficiently through the use of the standardized Liaison solution Greater ability to change Merck now has the ability to more easily change maps, making the data flow process more efficient Improved problem resolution Merck replaced what was a sequential error identification and resolution process with a more dynamic process. Initial indications are that the overall reduction in trending errors is on track to meet their business objectives. Greater capacity to handle multiple trials Because Merck vastly improved its data flow capabilities, it is now able to simultaneously conduct trials of more drugs, which is expected to increase its new drug pipeline More easily assimilate new business As Merck acquires new companies, it is better equipped to support clinical trial growth and volume

8 Keeping pharmaceutical and biotech companies at the forefront of innovation As the pharmaceutical and biotech industries continue to face new trends and challenges that hasten the tempo of business, innovation has become the most important precursor to profitability. It is only through the rapid integration and interpretation of intelligent data that business decisions can keep up with this accelerated pace. The vast amount of complex clinical data produced during product launches makes the life sciences industry ideal for early adoption of cloud-based technology. Companies that do so will find success and ease of implementation depend heavily on the proven expertise of their technology partners. Experienced global companies like Liaison Healthcare will continue to be at the forefront, delivering scalable, flexible data integration and harmonization solutions that can help their clients speed time to market and capitalize on the best commercial opportunities. About Liaison Liaison Technologies is a global integration, data harmonization and data management company, serving more than 600 customers in the healthcare industry. With customized solutions offered via a cloud-based platform, Liaison helps health systems, HIEs, pharmaceutical and bio-tech companies quickly secure meaningful use from a wide variety of health information. For more information, visit. For more information contact: 3157 Royal Drive Suite 200 Alpharetta, Georgia Tel: or Fax:

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