Transformations INSIDE THIS ISSUE: AN APPROACH TO EXTERNALIZING R&D INFORMATION MANAGEMENT

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1 Transformations OF SPECIAL INTEREST: RESULTWORKS NEWSLETTER VOLUME 12, ISSUE 1 Increased outsourcing by phase of R&D An informa on exchange strategy is cri cal to growth in R&D business outsourcing Business Process Management (BPM) tools solve workflow supply chain challenges Life Sciences companies are more interested and willing to host systems and data externally Poor data quality has significant hidden costs INSIDE THIS ISSUE: AN APPROACH TO EXTER NALIZING R&D INFOR MATION MANAGEMENT BPM FOR THE CLINICAL SUPPLY CHAIN HIDDEN COST OF DATA QUALITY RESULTWORKS NEWS 5 ABOUT RESULTWORKS AN APPROACH TO EXTERNALIZING R&D INFORMATION MANAGEMENT Externaliza on is rapidly evolving in Life Sciences well beyond the old outsourcing models. Although the need to innovate has never been greater in R&D, today s environment is growing in emphasis on effec veness at each step of the process. External organiza ons are emerging which are more specialized and therefore be er prepared for the volume and quality of work that is needed today. Not so long ago if you associated service with any one R&D organiza on, it was a dirty word and people were put off. Today, if you are in an R&D group and you are not behaving as a service provider, there are outside organiza ons willing to provide those services faster, be er, and cheaper. One stumbling block in the shi toward externaliza on has been informa on management. Informa on management is inherently more complex than the old Pharma model when businesses were rela vely self contained. Today, be er strategies are required when contempla ng who needs what data at what point in the process and who is BUSINESS PROCESS MANAGEMENT LINKS YOUR CLINICAL SUPPLY CHAIN Clinical supply chains have been reliant on specialized external partners for many years. Nonetheless, like the rest of the Life Sciences product lifecycle, this area has been under increasing pressure with a growth in the number of partner organiza ons, increasing informa on flow, and the need for greater speed and versa lity at the same me. Exis ng internal supply chain systems are making it difficult for the business to promote new processes given the silo ed nature of the infrastructure. Further complica ng this is an increased reliance on diverse systems u lized by mul ple partners. Underway in many leading Pharma organiza ons is an overhaul in the infrastructure to support new supply chain strategies. What should not be overlooked is an overhaul of the business processes to execute clinical supply chain (CSC) ac vi es. Be er defini on of business processes allowing for process varia ons plus an explicit use of business process management (BPM) tools allows the business more flexibility while leveraging technology advances. Define Key CSC Business Processes A high level clinical supply chain process is shown in Figure 5. Each process encompasses key providing data at each step in what form. You also need the right tools to acquire, organize, and access data from different sources for a variety of purposes. This ar cle outlines an approach to establishing an informa on management strategy in organiza ons that are increasingly trending towards externaliza on. Who s Your Partner? As some Pharma organiza ons cling to the tradi onal business models, others are strategically weighing broader partner strate (Con nued on page 2) data and relies on numerous transac ons to progress supplies from API to drug product when and where needed globally. Since clinical studies are subject to so many variables, clinical supply chain processes must be much more versa le than tradi onal manufacturing processes. Some of those variables include: Number and diversity of studies across therapeu c areas Compliance challenges Diversity of inves ga ve sites, pa ents, treatments Real me evalua on of (Con nued on page 4)

2 TRANSFORMATIONS EXTERNALIZATION (CONTINUED FROM PAGE 1) Figure 1: Survey of Life Sciences companies engaged in outsourcing by phase gies. Although partner organiza ons used by one company today may be rela vely limited, it may be best to plan on a spectrum of partners. Certainly the trend is toward an increasingly diverse set of interchangeable partners. Figure 1 shows the results of a survey conducted by Nice Insight and published in Life Sciences Leader magazine indica ng outsourcing at high rates throughout the product lifecycle. Partners can also be differen ated by size, types of rela onship, sophis ca on, and volume of work ac vi es. Added to that is the fact that most projects involve mul ple partners. In another recent survey, respondents indicated that 74% of projects involved two or more partners while 17% involved more than four partners. Given this accelera ng trend, organiza ons need to think differently about how they work with partners from the scope of their ac vi es to the onboarding process to the informa on flow at each stage of the process. Framework for Externaliza on Regardless of the drug development stage, once a determina on has been made to externalize that service, there are some key elements needed to facilitate the end to end process. The partner framework in Figure 2 highlights building blocks for considera on in contrac ng an external partner for a range of ac vi es. In each of the stages defined, considera on must be given to the informa on and business processes that drive the work before considering technologies to support it. Analyze the Business Process In the execu on of a study bidirec onal documents and data are rou nely exchanged on a transac on basis. A majority of this data transfer today s ll occurs via and file exchanges. However, these manual business processes will not scale as the business grows in volume and complexity. In order to understand what informa on is needed in what form and for what purpose, the informa on needs to be be er defined and categorized. Define the Informa on There are numerous data sets in Pharma R&D that are specialized for a par cular science or process. Generally the data might be categorized as follows: Tradi onal scien fic data based on studies and experiments Detailed result data including mul parametric data, instrument data, images, video, etc. Summarized result data in tables and spreadsheets Documents and reports which likely include some or all of the data described above Opera onal data about programs, projects, or studies regarding status, tracking, repor ng, etc. Unfortunately, this data is rarely well standardized making it difficult to bring together Figure 2: Partner Framework data from the same company internal groups let alone data from different parts of the product lifecycle, from different partners, and from different stages in the partner framework. Clearly, the details are cri cal as organiza ons a empt to employ technologies to scale the process. Harmonize Informa on Knowing that data will be used and integrated in a variety of ways over me, it is important to harmonize informa on at some point in the process. As informa on is created, it is cri cal that harmonized vocabularies and metadata are injected applying the same nomenclature that will be used throughout the extended enterprise. Preferably standards will be employed to facilitate the broadest use across partner organiza ons. Certainly SEND and SDTM standards from CDISC for nonclinical and clinical data respec vely is a great star ng point. Company and metadata standards are also required so that master data items are consistently used and referenced with a common nomenclature. This said, CRO s are adop ng at a much faster rate than Pharma according to a CDISC survey published in October So Pharma companies need to step it up. Point of A ack for Harmoniza on PAGE 2 Business rules associated with the exchange of informa on and the technologies for the exchange need to be designed in a versa le way for mul ple, diverse partners. Developing use cases helps to draw out the issues and challenges of each scenario with par cipa ng organiza ons. Where harmoniza on occurs is a big considera on which also es to the method of data exchange. In a tradi onal ETL (extract, transform, load) model, harmoniza on would occur once external files (e.g., (Con nued on page 3) documents, spreadsheets) are brought into

3 VOLUME 12 ISSUE 1 PAGE 3 EXTERNALIZATION (CONTINUED FROM PAGE 2) Figure 3: Result Data Remains at Source the company and loaded into company systems. Another approach would be to use business process management (BPM) tools to facilitate external partner data entry and upload. Again in this scenario the harmoniza on would occur within the company requiring some manual effort as well as technology to make the data accessible. A third approach as shown in Figure 3 puts the onus on the partner organiza on to harmonize data and documents and to facilitate managing the data at the source. In the final approach shown in Figure 4, third party tools are used to conduct the harmoniza on and the data exchange in the cloud based service. Data could then reside in the cloud applica on and accessed as needed via other data services. Conclusions Developing an externalized informa on management solu on can be overwhelming because it is inherently complicated on many levels. While the challenge must be addressed holis cally, the problems need to be dissected and then tackled in stages. Where at all possible, rely on industry standards as the founda on of vocabulary and metadata harmoniza on, and distribute the harmoniza on work among par cipants. Preferably that occurs at the source when data is created. Likewise, leave the data at the source when possible. In order to do this, decisions need to be made regarding what data and documents need to be brought in house, and what can be managed by trusted partners. Minimizing the physical transfer of data will minimize backend work required to manage the informa on and the infrastructure to support it. As the numbers of partners grow, recognize that not all partners are created equal, and they will change over me. In order to maintain a versa le informa on management environment for the business, a range of solu ons of varying complexity are needed that can accommodate different partners, processes, and informa on. Finally, one size technologies do not fit all situa ons. There are excellent and evolving tools today so leverage the best in class technology building blocks for an op mal solu on in the evolving externalized informa on environment. Figure 4: Cloud-based Harmonization and Exchange

4 TRANSFORMATIONS PAGE 4 BPM FOR CLINICAL SUPPLY CHAIN (CONTINUED FROM PAGE 1) Plans should also allow for processes to evolve with the business. So planning for several years to design the ul mate clinical supply chain processes and systems is not an op on anymore. Figure 5: Clinical Supply Chain Process events, processing informa on, and adjustments Partner involvement Moving toward well described business processes is fundamental to an effec ve clinical Fast Forward Cri cal business process analysis is really a key factor in looking forward. New business processes need to account for the variety of ways that supply chain work could be conducted from tradi onal in house managed studies to contrac ng with partners of varying capabili es for all or any part of a study. Fortunately BPM tools have evolved significantly over the last few years. As Figure 6 shows, BPM can be used to facilitate workflows among in house groups and with partner organiza ons. These tools can be used in a building block fashion to support mul ple ways of execu ng a process based on different triggers or transac ons. In addi on, BPM tools can provide the link to the back office systems some of which might be legacy systems; others might be newer technology; s ll others might be systems operated by partner organiza ons. BPM for Rapid Implementa on and Versa lity Business process management tools can be used to create and manage business processes outside of key opera onal systems as depicted in Figure 7. Ac vi es such as those listed below can be implemented for versa le workflows: Event management and tracking Request/fulfillment management and tracking Rou ng and approvals Acknowledge receipt of material Figure 6: BPM Opportunities supply chain. Those business processes must account for an cipated varia ons across the different environments that the supply chain supports. Most pharmaceu cal organiza ons have relied historically on in house applica ons to facilitate key business processes with people filling in the gaps among processes and systems. Fortunately, newer technology than spreadsheets, s, and telecommunica ons are now available. Today s organiza ons need to manage many more studies with faster feedback loops and increased responsiveness, all while opera ng with fewer in house resources. Without be er processes and systems, the old models just will not scale. (Con nued on page 5) Figure 7: Facilitating Business Processes

5 RESULTWORKS NEWSLETTER VOLUME 12, ISSUE 1 PAGE 5 BPM FOR SUPPLY CHAIN (FROM PAGE 4) Trigger ac ons based on changes in protocol, material damage, or expira on Update inventories Collect and harmonize metadata BPM tools can also be used to bridge different systems triggering a series of events to keep supply chain systems synchronized while further enabling the clinical supply workflow. Conclusions Business process management has come of age. BPM tools can be used to enable clinical supply chain processes whether they are conducted internal to the Pharma company or by an external partner organiza on. Some benefits of BPM tools include: Removal of manual steps involved in triggering workflow ac vi es Replacing s and other manual processes with workflow tools accessible to the company and partner organiza ons Increased visibility, history, and tracking of requests, responses, events and other ac vi es Automated steps where informa on is already available to take ac ons Linkage among key supply chain systems Ability to monitor cycle mes Organiza onal and partner performance. Re thinking and re designing clinical supply chain processes are an inherent element of new clinical supply chain strategies. Using BPM tools to realize those process changes makes the implementa on easier and more versa le as the business con nues to evolve. HIDDEN COST OF DATA QUALITY Since our ar cles, posters, and presenta ons on data quality, a number of people have asked about quan fying the cost of data quality. Most people indicate by gut that the costs are high but not quan fied and not addressed un l a significant event occurs. In his book Data Driven: Profi ng from Your Most Important Business Asset, Tom Redman calls out data quality as an "equal opportunity peril" that costs organiza ons between 10 to 20 percent of revenue. In our Life Sciences R&D world, we can reasonably equate that to the same percentage of the R&D budget. Redman goes on to suggest that one of the most important data quality lessons to learn from the companies that handle it best is you need to focus on preven ng errors at their source, not in finding and fixing them as they crop up. So much for relying on Google search to resolve all of the bad data woes. In an HBR blog earlier this year, Redman describes how to Make Data Work Throughout Your Organiza on. In the blog he recommends: Improve the data Make sure the data are properly, clearly, and consistently defined across the organiza on, improve quality, and promote sharing across units. Create processes to put data to work across the enterprise. Invest in people so they can be er manage the data organiza on Strive to empower all with data to make everyone more effec ve. As Life Sciences data con nues to undergo explosive growth and as it gets more complex each year e.g. due to externaliza on diligence to data quality as it is being generated will be er assure that precious R&D investments are going toward innova on and not to fix past has ness. How much is data quality cos ng you? To read the full blog by Redman, click here. RESULTWORKS NEWS Recent and Upcoming Appearances: Bio IT 2012 Conference DIA 2012 Collaborate to Innovate LRIG Mid Atlan c, New England, Philadelphia Society of Laboratory Automa on & Screening Conference Sample Client Ini a ves: R&D Knowledge Management Ini a ve Clinical Supply Chain IT Strategy and Implementa on Business Externaliza on Informa on Management Lab Execu on System / ELN Implementa ons ABOUT RESULTWORKS ResultWorks is a professional services company offering strategy, business process, and informa cs consul ng for the Life Sciences industry. Results are achieved through skilled facilita on and excep onal management leadership. To request addi onal informa on: call us, send us an , or visit our website. Contact Us: 1060 First Avenue, Suite 400, King of Prussia, PA, USA Phone: marke Website: ResultWorks, LLC

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