Managing Paper at Its Roots: Extending Beyond Document Management to Enterprise Content Compliance

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1 Managing Paper at Its Roots: Extending Beyond Document Management to Enterprise Content Compliance Global Headquarters: 5 Speen Street Framingham, MA USA P F RESEARCH STUDY Sponsored by: Virtify Inc. Alan S. Louie, Ph.D. February 2010 EXECUTIVE SUMMARY The shift away from traditional paper-based processes in the life science industry is being actively driven by an intense need for efficiency and cost reductions as well as a heightened focus on addressing a continued push toward stricter regulations surrounding the submission process, including disclosure activities and other estandards-based compliance mandates. In an industry slow to change, in part due to high regulatory scrutiny, validated environments, and process conservatism, the move toward electronic information management is only now taking place. As companies begin the move away from paper, they are being confronted with a wide variety of options, ranging from the electronic equivalent of paper to more dramatically different approaches to information management. In most cases, companies are proceeding cautiously and advancing efforts incrementally. As companies look forward, they have the opportunity to take advantage of innovation from outside the industry as well as solutions developed specifically for the life science industry. To be successful in this increasingly fast-moving environment, companies should look beyond their current needs toward processes and solutions that can begin to more effectively streamline information flow both within and outside their organizations. This study describes the historical path from paper to electronic processes through a number of optical lenses. Specifically, it: Highlights current trends in the industry Looks more deeply into the application of enterprise content management (ECM) solutions across the industry as well as ECM's utility in the regulatory submissions and compliance area Quantifies potential benefits that could be attained from the conversion from paper to electronic processes Looks forward to opportunities for ECM to move beyond document-centric approaches to more content/information-centric approaches to information management To be successful in this increasingly fastmoving environment, companies should look beyond their current needs toward processes and solutions that can begin to more effectively streamline information flow both within and outside their organizations. February 2010, Health Industry Insights #HI222097

2 Finally, in looking beyond current efforts, this document considers enterprise content compliance (ECC) as a transformative, regulatory compliant ECM approach that promises to improve information workflows by more effectively linking data, information, and reporting across the drug and device product continuum. IN THIS RESEARCH STUDY This research study highlights the shift from paper-based processes to electronic and enterprise-based approaches that is occurring as the industry looks to improve overall operational efficiencies in the product development process. Key drivers advancing the adoption of ECM are identified, both from a general perspective and in the regulatory submissions process. The document highlights quantitative benefits offered by the use of ECM and the anticipated evolution of ECM into ECC solutions. METHODOLOGY A life science centric survey was conducted from August to October 2009 focused on practices and trends in enterprise content management collaboration needs in the regulatory submissions process. The survey consisted of 26 phone surveys with industry professionals working in regulatory affairs management and/or compliance. Participant profiles for respondents are included in Figure 1. A second effort based on three in-depth interviews with senior-level industry executives was also conducted in parallel with the broader survey to gain specific insights representing small, medium-sized, and large pharma/biotech company perspectives. These interviews were used to develop a better understanding of organizational metrics and the specific use of enterprise content compliance solutions in different parts of the industry. Results from both efforts were key to the development of this document. Detailed insights from this study can be found in the Appendix. This data is available for those readers interested in a more in-depth assessment of the survey results. Page 2 #HI Health Industry Insights, an IDC Company

3 FIGURE 1 Clinical Development Survey Respondent Demographics Demographics Revenue $5 billion + 31% $2 billion to $5 billion 31% $500 million to $2 billion 35% CRO/CSO (11.9%) Medical device (11.0%) n = 26 < $500 million 4% Pharmaceutical (55.0%) Headquarters Location Biotechnology (22.0%) North America 54% Europe 23% Asia/Pacific 23% Source: IDC Health Insights, 2009 SITUATION OVERVIEW From Legacy to the Future The Active Paper Legacy in Life Science Content Management Historically, the conduct of clinical trials and the subsequent submission of a new drug application entailed the creation and management of millions of individual paper documents. Paper case reporting forms generated as a result of a patient interaction with the trial principal investigator were mailed or faxed to the project's clinical research associate and results were collated into a project spreadsheet (also paper). And the process continued, ideally to the point where one or more tractor-trailers, filled with regulatory submissions documents, were driven to Washington, D.C., as the final step in completing a new drug submission. Thus began the entrenched legacy of paper in the drug development process. Within most, if not all, organizations, these specific functions were separate from each other and managed in isolation. As a result, both data and processes tended to be siloed on a functional basis. Recognizing early the need to maintain a fully regulatory compliant work environment, organizations were often very slow to change management processes due to the large amount of effort required to convert and revalidate existing processes. As a result, most processes remained significantly out of date with productivity advances available as a result of technological innovations Health Industry Insights, an IDC Company #HI Page 3

4 The Life Sciences: An Industry Slow to Change While technological innovation has been a major contributor to transformation in other industries, adoption has lagged in the life science industry. The specialized skills required to develop new drugs, combined with a healthy profitability cushion, enabled the industry to assert that best practices from other industries could not be easily leveraged. With revenue stability faltering and new drug pipelines unable to fill future needs, this reticence has been replaced with a practical, more pragmatic view of the opportunity to leverage innovation in pursuit of improved operational efficiencies. It remains clear that paper continues to be a major component of information management in life science companies today, supported by survey data from this study (see Figure 2 in the Appendix). The total cost, time, and effort required to commercialize a new drug continues to grow (taking as many as 14 years and as much as $1.2 billion per drug), and at the same time, drug company revenues are expected to decrease due to loss of patent protection for major blockbuster drugs. These trends are well recognized by the industry, and significant steps have been initiated to cut costs and improve efficiencies in anticipation of leaner times. The specialized skills required to develop new drugs, combined with a healthy profitability cushion, enabled the industry to assert that best practices from other industries could not be easily leveraged. With revenue stability faltering and new drug pipelines unable to fill future needs, this reticence has been replaced with a practical, more pragmatic view of the opportunity to leverage innovation in pursuit of improved operational efficiencies. The cost of bringing new drugs to market ranges from $800 million to $1.2 billion, and it's estimated that roughly a quarter of the cost comes from the content requirements associated with working in a regulatory compliant environment. Concurrently, the clinical development process is also changing, based on several independent factors, including a changing global operating environment, new emerging target markets requiring country-specific data, technology-enabled interconnectivity, and a move beyond the primary historical drug markets of the United States, Europe, and Japan requiring new regulatory responses. These factors are contributing to increased complexity in the drug development process and the need to operate efficiently and effectively in an increasingly distributed, 24 x 7, global work environment. Each of these factors also adds to the complexity of effectively managing the information needed to advance drug development efforts. The information collected in the course of a clinical trial is generically defined as "content," and efforts to convert from traditional paper data collection to its electronic equivalent were initiated as the industry began its pursuit of improved efficiencies. Significant progress in this area can be found in the move from paper-based clinical and regulatory processes to eclinical and esubmission solutions, including the move toward electronic data capture (EDC) in clinical trials, the emergence of the electronic common technical document (ectd), the growth of structured product labeling (SPL) and product information management (PIM) in Europe, and the growing demands of clinical trial disclosure. Page 4 #HI Health Industry Insights, an IDC Company

5 Information Management Moves to the Foreground The conversion from paper to electronic paper (i.e., electronic document management) has been only the first step in the required transformation of information management in the drug development industry. It is clear that effective management of content across the entire drug development continuum is key to both optimizing overall operational efficiency and shortening time to market. As companies look for all options to both cut costs and improve efficiencies, they are more willing to look to drastically different information management approaches that could dramatically improve processes. Companies are currently viewing information management as a discrete activity and have not yet advanced toward a more holistic view of information as part of organizationwide processes. For additional insights regarding the state of information management processes within life science organizations, see the survey results shown in Figure 3 in the Appendix. Beyond improvements in internal information management processes, the opportunity for improved operational efficiencies extends into regulatory submissions and compliance processes. Parallel efforts by companies, vendors, and the U.S. FDA and other regulatory organizations have effectively enabled electronic transmission as an option for both new drug submissions and required regulatory reporting. Near-term benefits of the conversion have been improved efficiencies in the submission process, less paper, and hopefully, shorter and more efficient regulatory reviews. Over the longer term, major additional benefits become apparent, including reduced time to market, more automated reporting, and improved response to drug safety issues. Enterprise Content Management Meets the Life Science Industry The impending loss of revenue from patent expirations and the need to dramatically improve operational efficiencies have forced life science companies to look beyond incremental process changes to more transformational approaches. As defined by the Association for Information and Image Management (AIIM): Enterprise Content Management (ECM) is the technologies used to capture, manage, store, preserve, and deliver content and documents related to organizational processes. ECM tools and strategies allow the management of an organization's unstructured information, wherever that information exists. The impending loss of revenue from patent expirations and the need to dramatically improve operational efficiencies have forced life science companies to look beyond incremental process changes to more transformational approaches Health Industry Insights, an IDC Company #HI Page 5

6 While likely to be dramatically different from current processes in place, the implementation of ECM clearly has the potential to streamline and improve existing life science processes. Survey respondents were asked to identify their top ECM drivers. As expected, key drivers impacting ECM focused strongly on automating data collection to streamline review and analysis and enhancing collaboration and information exchange. For additional insights regarding ECM drivers in the life sciences, see Figure 4 in the Appendix. A key consideration in the adoption of ECM in the life sciences is recognition of the opportunity to standardize data, document, and information management. Our research indicates that ECM is growing in its central role in information management, a trend that is expected to continue over the next several years. Additional survey results are provided in Figures 5 and 6 in the Appendix. Enterprise Content Compliance: The Future of Content Management The commercial ECM solution marketplace is in a state of evolution but continues to expand as the industry benefits from the new features and functions of the solutions. Many ECM solutions are primarily electronic substitutions for their original paper counterparts, supplemented by supporting electronic infrastructure to track, organize, and manage the electronic documents. (In some regards, these ECM solutions could be more accurately described as enterprise document management [EDM] solutions.) While this approach is adequate to meet basic document management needs today, it is limited in its scope and cannot be easily leveraged as organizations seek to better use and exploit available data companywide. Thus, a more opportunistic use of ECM solutions replaces the document-centric approach with a more content-centric one. The content-centric approach has the potential to simplify document management through a focus on the underlying content and generating, compiling, managing, and reviewing documents and other required reports that are compliant with current, new, and emerging regulatory requirements. This continuing evolution beyond ECM to comprehensive ECC solutions better enables organizations to more effectively manage and automate complex regulatory compliance and content exchange needs both across the organization and throughout the entire product life cycle. This continuing evolution beyond ECM to comprehensive ECC better enables organizations to more effectively manage and automate complex regulatory compliance and content exchange needs both across the organization and throughout the entire product life cycle. Page 6 #HI Health Industry Insights, an IDC Company

7 ECC: Putting the Content Back into ECM The highly regulated drug development industry is particularly well suited to exploit ECC. With considerable numbers of related and standardized SOP, quality, validation, manufacturing, and regulatory documents, any changes to common forms could require that hundreds or thousands of validated documents be changed. The potential to change and validate a single document template would greatly simplify the process, saving time, effort, and money. While many organizations might question whether such changes are likely, consider changing regulatory mandates, labeling changes, new protocol development, regular reporting requirements (e.g., drug safety reporting), and creation of marketing collateral for multiple markets. By combining capabilities for centralized content collaboration and reuse within a standards-based environment, ECC solutions, with their focus on content reuse, are core to eliminating a significant amount of repetitious, low-value, document-centric effort from the process, freeing up staff for more important efforts. Quantifying Benefits Today On average, respondents indicated 26% of the time and cost of product development could be attributed to document and compliance issues. This finding is consistent with other IDC data and suggests that improved efficiencies in this area could substantially reduce the time and cost of bringing a new drug to market. ECC has the potential to eliminate a significant amount of repetitious, low-value, document-centric effort from the process, freeing up staff for more important efforts. While it's too early in the ECC evolution to draw quantitative conclusions, one can investigate the savings from ECM as a baseline and assume that ECC will exceed these productivity gains. Automating Content Reuse and Compliance: The Practical Benefits of Enterprise Content Compliance In the ECC approach (unlike the ECM approach), documents are generated as the output of a validated workflow, and content not documents is the core element in the process. The ECC approach to managing these types of documents will likely include the following processes: The ability to create, validate, and change content in a collaborative yet centrally managed environment and then reuse it infinitely The ability to create and validate regulated content and reuse it across the product development continuum (e.g., clinical trial registration and results postings, electronic submission reports, labeling, marketing collateral) 2010 Health Industry Insights, an IDC Company #HI Page 7

8 Collaboration and workflow management features designed to integrate critical people and siloed processes The ability to identify and tag key data elements or "fragments" for use by business users in the creation of regulated documents (e.g., SOP, quality, validation, manufacturing, and regulatory documents) Out-of-the-box compliance with new and evolving global standards Vendor-neutral technology that can work in conjunction with existing commercial ECM solutions, databases, and infrastructure Extending Benefits from ECC Beyond Organizational Boundaries The application of ECC to regulatory submissions document creation is a strong representative of ECC's potential. For example, the reporting of severe adverse events (SAEs) would exploit the required common forms necessary to respond to multiple regulatory authorities simultaneously, include only those variables and parameters that are appropriate to the specific drug of concern, and ensure that all necessary data was present prior to submission. Within a large complex organization such as a multinational pharmaceutical company, ECC offers the ability to standardize on a common platform for consistent, centralized content management and form generation. As mentioned previously, SOPs, quality assurance, manufacturing, and regulatory documentation, in addition to clinical trial registries, electronic submission reporting, and labeling, are areas where ECC is likely to deliver substantial benefits. FUTURE OUTLOOK If properly implemented, ECC can be transformative to business process and information management within a life science company. ECC is a substantial shift away from traditional document management and is part of the process of automating the flow of information across the complete drug life cycle. If properly implemented, ECC can be transformative to business process and information management within a life science company. The near-term benefits of ECC are clear and include: Building on the process efficiencies inherent in ECM Cost savings from the integration of disparate content silos Reduced errors and rework through the automated use (and reuse) of content across product life-cycle activities and regulatory requirements (esubmissions, global labeling, clinical trial disclosure) Page 8 #HI Health Industry Insights, an IDC Company

9 Direct improvement in operational efficiencies by collecting the correct data the first time, simplifying information retrieval and reporting, ensuring completeness of data (e.g., in responses to FDA queries), and creating reusable/leverageable processes Applicability to both internal and external documents Delivering improved document and regulatory compliance at lower costs and in shorter times Over the long term, ECC promises to: Automate the flow of information and compliance across the drug development life cycle Change the role of documents in the drug development process Automate regulatory compliance reporting on a global basis Streamline information management and shorten the overall time needed to bring drugs to market APPENDIX This section includes much of the supporting data collected in the course of the study. This data has been included for those readers interested in more in-depth analysis of the survey results Health Industry Insights, an IDC Company #HI Page 9

10 FIGURE 2 Current Industry Approaches to ECM We have both paper-based and ECM solutions in place ECM is core to our regulatory submissions efforts ECM is core to our regulatory compliance efforts ECM is a core element in our management of data ECM is core to our overall information management ECM is one of many tools that we use in managing information (% of respondents) Source: IDC Health Insights, 2010 Page 10 #HI Health Industry Insights, an IDC Company

11 FIGURE 3 The State of Information Management Capabilities Within Life Science Companies Accumulating data and information for regulatory submissions Developing documentation Managing document version control Tracking and tracing of information in the organization Managing information security Managing data Tracking project progress Managing information process workflow (% of respondents) 1 = low capability = best in class Source: IDC Health Insights, Health Industry Insights, an IDC Company #HI Page 11

12 FIGURE 4 Top Drivers Impacting ECM Efficient processes to bring together data for review and analysis Secure collaboration and information exchange among project team members Accuracy and completeness of research studies Accuracy and efficiency of the review cycle between internal reviewers and joint ventures, contributors, and other stakeholders Protection of intellectual property Compliance with regulatory mandates Reducing delays in accessing data Delays from lost data and the need to repeat studies (% of respondents) Source: IDC Health Insights, 2010 Page 12 #HI Health Industry Insights, an IDC Company

13 FIGURE 5 Current Industry Use of ECM ECM is the core approach to keeping track of our documentation ECM is the primary archiving tool in our organization ECM is the primary tool for preparing regulatory submissions ECM tools are the primary repository for our data and information ECM is the primary tool for maintaining regulatory compliance We have multiple ECM solutions in place, depending on the application (% of respondents) Source: IDC Health Insights, Health Industry Insights, an IDC Company #HI Page 13

14 FIGURE 6 Top Drivers Impacting ECM Use in Regulatory Submissions Processes Accuracy and completeness of regulatory submissions Efficient processes to regularly create documents for submission Secure collaboration and information exchange among project team members Secure transfer of submissions to regulatory agencies Compliance with regulatory mandates Efficiency of the regulatory review cycle Protection of intellectual property Accuracy and efficiency of the review cycle between internal reviewers and joint ventures, contributors, and other stakeholders Source: IDC Health Insights, (% of respondents) Copyright Notice Copyright 2010 Health Industry Insights, an IDC company. Reproduction without written permission is completely forbidden. External Publication of Health Industry Insights Information and Data: Any Health Industry Insights information that is to be used in advertising, press releases, or promotional materials requires prior written approval from the appropriate Health Industry Insights Vice President. A draft of the proposed document should accompany any such request. Health Industry Insights reserves the right to deny approval of external usage for any reason. This document was reprinted by Virtify with permission from Health Industry Insights. Page 14 #HI Health Industry Insights, an IDC Company

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