managing regulatory information as a corporate...

Managing Regulatory Information as a Corporate Asset Industry, Health Authority, and Vendor Trends

Gens and Associates RIM Whitepaper

Fall 2013

Based on our 2013 Empirical Industry Study

Prepared By:

Steve Gens: Managing Partner, Gens and Associates Inc.

Greg Brolund: Chicopee Falls Consulting, LLC.

Managing Regulatory Information as a Corporate Asset Fall 2013

Introduction

Our annual industry white paper is written to provide a current state of Regulatory Information Management (RIM) along with a perspective of where RIM is headed, key trends and projected change. This is based upon several biopharmaceutical benchmark studies, client work, and our professional experiences. RIM continues to mature and grow in operational and strategic value with most companies having a RIM strategy or in the process of developing one. We see these salient points as key 2013/2014 themes:

1) Regulatory information is an enterprise asset used by many functions (see Figure 1) requiring formal program management and governance

2) Most RIM programs have varying degrees of effectiveness, but are viewed as inefficient

3) Global expansion, consistent Health Authority interactions, functional automation, and public information transparency are driving significant change

4) The pace of industry change is greater than the solution providers ability to innovate and this is a growing issue and industry challenge

5) RIM programs need better performance metrics, formal continuous improvement approaches, and improved data governance to impact efficiency and reduce the risk of non-compliance

6) Dossier outsourcing has transitioned to strategic partnerships with a growing attention to the CTA and affiliate e-submission

The following perspective is based upon several industry benchmarks including our large March 2013 RIM study of 37 companies which focused on Top 70 biopharmaceuticals. This study had a solid distribution of company size (see Figure 2) and geographic locations (EU, Japan, US). The whitepaper structure is:

• Executive Summary • RIM Scope, Priorities and Trends • Global Product Registration and Submission Management • Health Authority Interactions (Q&A, Correspondence, Commitments) • Information Architecture / Cloud / Social Networking Trends • Standards Initiatives and Adoption (HA / Industry) • Vendor Landscape: Status, Issues and Opportunities • Conclusion: Key Questions

We hope this information is insightful and valuable. Please contact us with any questions.

Figure 1 - RIM Stakeholders

Figure 2 - 2013 RIM Study Demographic

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RIM Summary

Our 2012 paper described RIM at an inflection point both for industry and the vendor community. We see an acceleration of industry and regulatory change in just the past 12 months with RIM innovation becoming a critical goal to increase business efficiency, achieve lean global operations and to reduce the risk profile and cost to ensure regulatory compliance. This year’s empirical study defined RIM in 14 components or capabilities (see Figure 3). We asked participants which components were considered within their RIM scope (percentage on the left) and did they see the component as effectiveness (red percentage at the right). As expected, many of the traditional RIM components such as submission EDMS, publishing, archive and dossier management received high effectiveness ratings. However, foundational elements such as data governance and information exchange standards and key process touch-points (e.g. supply release) received very low effectiveness ratings. This demonstrates the complexity of transitioning from a collection of disparate processes / systems to achieving an effective RIM global capability. For many, this requires a transformation covering organization, process, systems, terminology, culture, and roles. To achieve a true global RIM capability, one must invest in “low visible” foundation areas such as information architecture, data standards / governance, and collaborative technologies in addition to having robust systems with high usability. RIM is about a mindset where individual stakeholders understand the collective benefit and their role in the bigger picture that drives timely and quality entry of individual information. We were challenged by one participant to summarize this year’s RIM benchmark in one slide demonstrating industry position and their company comparison. We developed this quadrant chart (see Figure 4) depicting RIM effectiveness (14 components) by foundational / quality measures. Each company rated each of their 14 RIM categories by a 4 point scale (no neutral) and the foundational/data quality calculation was derived from these survey questions:

1. Data Quality Program Effectiveness 2. Data Verification Methods 3. Degree of Implemented Authoritative Sources 4. Information Architecture Status 5. Data Governance Effectiveness 6. 3rd Partner Access

Figure 3 - Regulatory Information Management Scope

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This analysis finds three cohorts with few outliers. We believe this supports our “inflection point” view and describes the significant investment most organization are making or plan to be make in foundational areas, policy, and continuous improvements to achieve a “trusted” source of regulatory information. This is in addition to the typical system/process investment cycle. It’s about the RIM program and no longer individual capabilities. Finally, most companies are continuing to explore ways to lower their overall total cost of ownership. This has resulted in aggressive publishing outsourcing within the pasts two years and analysis of alternative solution hosting concepts such as Software as a Service (SaaS) and cloud computing. We find an increase in the investigation and use of the SaaS model in small and mid-tier companies, but minimal use in large bio-pharmaceuticals. While several RIM vendors are heavily investing in cloud computing and many biopharmaceutical companies are interested, a significant adoption level is, in our opinion, still a few years away. Industry RIM Priority and Challenges

Figure 5 shows significant investment in most RIM areas especially submission planning, health authority interactions and data exchange standards. This is a shift from the primary investment area of product registration from our 2009 and 2011 surveys. The white boxes combine those currently changing with those with plans to change within the next two years and are sorted from the most change (left) to the least change (right).

Figure 5 – 2013 Projected Change per Category Type

Figure 4 - 2013 RIM Study: Industry Position

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We asked several general questions in our 2013 RIM survey regarding business and information technology priorities with the following results: Business Priorities:

1. Improve cross functional information exchange and processes 2. Consolidate systems and implement authoritative information sources 3. Enhance data quality and data validation processes 4. Globalize key processes and systems

Information Technology Priorities:

1. Improve search, reporting and analytics (get more value out of existing assets) 2. Improve existing technology (accessibility and performance) 3. Improve affiliate / regional office ability to enter and access regulatory information 4. Implement an authoritative source of trusted regulatory information

These themes support the movement to a global enterprise capability to support day to day business regardless of geographic location and for strategic aspects of managing the global product portfolio. This vision is starting to become a reality for many organizations.

Given this, we expected to see an increase in the use of performance metrics for quality, efficiency, productivity and activity. While most are just measuring activity volume, there is clear direction towards expanding formal performance metrics and continuous improvement programs over the next two years (see Figure 6). We are considering including this topic in our 2014 research plan.

Global Product Registration Management

We have witnessed significant activity in this area since 2009 as many companies have worked hard on deploying a global authoritative source for the entire product lifecycle (investigational through life-cycle management). Our data concludes companies are either expanding their existing program or consolidating highly fragmented regulatory information which is scattered across systems and geographies into one trusted global source. Today, 70% have a global system (many of which maintain regional or local systems) with 62% citing this capability as

Figure 6 - RIM Performance Metric Categories

Figure 7 - Projected Adoption

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Figure 8 - Data Entry Practices

effective. We see investment peeking in this critical area as 95% will achieve a single global authoritative source by 2015 (see Figure 7) from a base of 57% today. As these tend to be 3 year projects, many are still in-progress while several late adopters are just beginning. We see three distinct stages of investment and believe industry is transitioning into stage two:

1. Information consolidation to realize a true global authoritative source (2008 – 2015) 2. Incorporate health authority and industry data standards; improve usability (2011 – 2015) 3. Cloud or SaaS based options (2014 – 2018)

Many companies have started to prepare for next generation capabilities driven by health authority (e.g. XEVMPD) and industry (e.g. IDMP) data standards, the criticality of improved usability in all parts of the organization (central, regional and local) and cross-functional integrations (clinical, supply, manufacturing etc.). From a usability standpoint, we see four categories: 1) data entry flexibility by role or location, 2) device independent consumption (laptop, table, smartphone, and desktop), 3) simple user interface, smart reporting and analytics, and 4) connectivity regardless of location (mobility which is more a general business requirement). In 2011, we discussed our perspective that a strategic view of registration management is required to combine the full product life cycle management capability with an authoritative product dictionary source to support core regulatory activity tracking (submissions, correspondence, question and answers, and commitments). Several vendors adopted this view as most companies are taking a strategic view of RIM and looking for a partner offering multiple regulatory activities in a single or integrated capability as opposed to a very narrow focus on registration or product data alone. We continue to find companies “underestimating” the level of effort (time and budget) to execute these projects effectively as they typically do not have a detailed understanding of the degree of complexity at the local level. We conducted several client Local Operating Company (LOC) in the past 12 months that provided data to quantify the LOC status (tool utilization, time managing local information, time responding to central registration status request, unique requirements etc.) for several clients. This informed project timing, budgets and degree of complexity resulting in realistic expectations and accurate business cases.

We also stated in 2011 that most companies share common project goals / outcomes from a product registration capability while the implementations are vastly different. Our 2013 RIM survey asked several specific questions surrounding data entry and verification methods, authoritative source realization, and data quality programs. Several key findings include:

1. 70% have a global system, but only 57% cite an “authoritative” source

2. 65% have a combination of central, regional, and local data entry (see Figure 8)

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3. 22% cite the local level enters all information (this % is declining) 4. The remaining 13% have no clear method (consistently) for information entry and we

believe these companies are still in highly fragmented environments 5. Data verification methods are varied (see Figure 9)

Upon further analysis of the companies citing “effective” or “very effective” product registration capabilities, most have or will have a global authoritative source along with several information verification methods by 2014. There was no correlation between the data entry technique and the specific vendor to those that cited an effective capability. Finally, the vendor field continues to expand with several newcomers and those trying to improve their existing capabilities to compete with two clear market-leaders. Companies who cited “ineffective” had either an internally developed system, a customized system, or excel and are planning to change their tool set while those currently having an off-the-shelf market leading solution are not changing their technology. This data tells us the level of vendor maturity and those with market leading tools are primarily focused on program expansion and increasing data quality / governance effectiveness. Please see our vendor section later in this paper for specific details. Key Points:

• Common goal to achieve an authoritative source of product and registration information with significant work in common terminology and naming standards (master data)

• Significant focus on data governance model (entry and data validation) and ownership

• Commitment management criticality has increased for inspection support and risk management (status of work-in-progress vs. deadline)

• Consistency in Health Authority Q&A responses is a growing concern and focus of work

• The typical business case combines compliance, productivity and efficiency

• Enterprise application with several key integration points (clinical operations, manufacturing, supply, and business development)

Global Submission Management and Publishing

Global submission management is predicted to be the top area of change over the next two years as companies are trying to effectively manage a global portfolio from a book of business standpoint. Global submission planning (forecasting) and improved efficiency in production planning (weekly demand and resource planning) are common initiatives for most companies. At

Figure 9 - Data Verification Methods

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the same time, a significant push for strategic sourcing partners is under way as 59% have adopted this strategy.

The publishing sourcing trend is dramatic (see Figure 10) as companies are moving aggressively towards outsourcing or internal work redistribution to internal sites in India and China. Several large companies have entered into a variety of sourcing agreements such as functional outsourcing, offshore utilizing internal systems, application type outsourcing or rebadging. The trend in our outsourcing benchmarks is very interesting as 2008, 2011, and now 2013 are key decision point years as industry determined whether to outsource more (new or expanded) or not. Our 2013 benchmark (see Figure 10) finds 76% with some type of outsourcing with 49% in analysis mode. What we do know is the outsourcing deals are much larger and are shifting to more strategic relationships. The focus of dossier sourcing is also shifting. A dramatic increase in CTA outsourcing is underway and many are investigating this option. Our working hypothesis is more countries are involved in the R&D process leading to a greater reliance on contract research organizations (CRO) and increased business need for these CRO’s to support both regulatory and clinical activities. Additionally, as more countries move to electronic submission formats (e.g. Saudi Arabia for eCTD), the business decision to either centralize or outsource is being made as opposed to placing expensive and complex publishing tools with the skilled resource at the local level. It also appears that some companies are “pulling back” in the outsourcing of study report publishing based on our 2011 to 2013 comparison (see Figure 11). Finally, the cost difference between “off-shore” and “on-shore” is not as great as often believed, since individual publishing rates are rising in off-shore locations and the cost of project/demand management is being accurately factored in financial models. As a result, some organizations are investigating publishing apprentice programs utilizing low-cost entry staff.

The typical regulatory operations function is managing growing complexity as individual country filing requirements continue to evolve and no central authoritative source of these filing requirements is easily available. There is continued frustration in not having an authoritative source for country specific filing requirements internally or a fee-based service from the supplier community.

Figure 10 - Dossier Outsourcing Direction

Figure 11 - Outsourcing by Application Type

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As stated last year, change in publishing tools continues to be relatively static as ‘patches” and “minor releases” keep regulatory operations busy. There is a desire to have less change as the time to re-validate is considerable. In addition, most are waiting to see the vendor RPS strategy and what impact (small or large) it will have on their publishing platforms.

Salient Points:

• Multiple e-submission formats, validation tools, and electronic gateways are increasing regulatory operations complexity

• National affiliate support for electronic submissions is a growing need and often satisfied through a regional / central operation or outsourcing

• Regulatory is evolving to a true global regulatory business model resulting in a more distributed regulatory strategy group and a centralized operations group

• Resourcing models (outsourcing or work redistribution to low cost regions) are in flux

• Off-the-shelf solutions providing an “authoritative source” of planning / tracking information are maturing

• Core Dossier programs continue to focus on “minimum builds”

Health Authority Interactions (Q&A, Correspondence, Commitments)

Management of Health Authority (HA) interactions is increasingly an industry challenge as global expansion is requiring consistency of interactions across regions. A growing approach to improve effectiveness and global visibility is to include HA interaction management within a comprehensive RIM solution; linking HA interactions with product registration and submission information, and archiving. Table 1 summarizes the responses from the 37 companies participating in the 2013 RIM survey.

Table 1 – Commitments and Correspondence

HA Commitments HA Correspondence Included in your RIM program 62% 70% Managed by a regional or local solution instead of or in addition to a global solution 49% 57%

Our process is “effective” 67% 68% Currently have an authoritative source 46% 40% Stored in central archive 62% 68% We are or will change our current solution 72% 78%

The recurring principles regarding effective Health Authority interactions are the need for global consistency and timeliness of responses to Health Authorities. In our 2013 survey and client work, there is widespread recognition that the ability to provide consistent information across global Health Authorities is critical and difficult to achieve. At the same time there is limited confidence that commitments and communications are being managed on a globally consistent

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basis. Historically, commitments have been difficult to manage globally because of the lack of a satisfactory definition of exactly what is a global Health Authority commitment. As a result, there are inconsistent processes for identifying and responding to HA commitments. Some are elevated to a global regulatory team and some are answered locally with little or no visibility among the appropriate global regulatory and global therapeutic groups. We believe the key factors that contribute to the difficulty in managing HA interactions include:

• Lack of a clear definition of what interactions, in addition to commitments, are important to be visible and managed globally

• Correspondence and HA questions and answers are conducted in the local language. Absent a clear process to determine what is important, the value of using scarce resources to translate from the local language is debatable

• Most companies have a portfolio of “mature” national products that are sold in limited areas and often do not have an active and knowledgeable support group in the company’s headquarters. Global management of interactions for these products is problematic

Salient Points: • Most large and mid-size companies include both commitments and correspondence in the

scope of their RIM program as compared to only 25% of small companies • A fairly high percentage (57%) of companies have regional and local solutions for HA

correspondence when compared to other RIM capabilities • While the management of both commitments and correspondence is considered effective

by most, the degree of change (72% and 78% respectively) is among the highest

Data Standards: XEVMPD and IDMP

Most companies will rely on software solutions to improve their support for Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) and to implement the Identification of Medicinal Products (IDMP) standards. (see Figure 12) We believe this data suggests most companies will not make fundamental changes to the vocabulary and standards in their internal regulatory information systems to support the new standards. Instead, they will depend on terminology mapping and software solutions to produce the required submissions and reports for health authorities.

The development and implementation of the XEVMPD and IDMP standards has been largely driven by the need to uniquely identify pharmaceutical and medicinal products, especially from a pharmacovigilance perspective. The development of the IDMP standard is associated with the new standard for submission of individual case safety reports (ICSR) although the new ICSR

Figure 12 - XEVMPD Post July 2012 approach

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standard is designed to be able to be implemented with or without the implementation of the IDMP standards.

There is concern that the IDMP standard will not be implemented in the same way by major health authorities. The International Conference on Haromisation (ICH) M5 working group was responsible for harmonizing implementation of the IDMP standard among the ICH countries. However, not all ICH members supported the IDMP standard and the M5 working group was disbanded. Implementation will be independent of the ICH process and the ICH guiding principle of harmonization. The US FDA, EMA, Health Canada and SwissMedic are currently planning on moving forward with IDMP but only the EMA has identified a date for adoption (2016).

We believe this is another factor that is driving most companies to consider a “mapping” approach to comply with, what are likely to be, different regional and local implementation requirements.

Salient Points

• 64% are investing in new or updated systems and tools to support XEVMPD • More small companies (38%) are planning to outsource XEVMPD support than large or

mid-tier companies • By more than a 2 to 1 margin, software solutions are taking precedence over

organizational or process changes to prepare for IDMP, suggesting the reliance on software vendors to provide the solution to IDMP implementation and compliance

• 43% of 2013 participants are planning to augment their staff with external consultants to implement new standards and technology

Information Architecture / Cloud

Information Architecture (IA) The level of interest in establishing regulatory information architecture reflects the need to change the way data has been managed with legacy systems and processes. The industry has a long industry history of silo’ed, purpose built systems and processes. Each system was designed to manage information for a specific regulatory activity and frequently did not use an enterprise set of data and process standards, except at the most elementary level. The observed increased emphasis on information architecture is a result of the recognized need to establish a clear authoritative source for regulatory information and to share information for the end to end management of regulatory information. Our 2013 survey, demonstrated that 78% of the participants have an active regulatory information architecture program or are planning to start a formal regulatory information architecture program. Salient Points (see Figure 13)

• The percentage of companies that started regulatory IA programs is significantly higher than the rate reported in our 2011 survey

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• 43% of the participating companies are actively engaged in establishing a regulatory information architecture with another 27% in the planning phase

• The number of companies reporting a mature regulatory IA program grew from 4% in 2011 to 11% in 2013. This reflects the complexity and effort required to establish comprehensive information architecture.

Figure 13- Regulatory IA Status

Regulatory information architecture programs include more than the traditional elements such as definitions of data types, format and content standardization. In order to fully support an end to end process for regulatory and related functional capabilities, companies are including additional elements in their IA. These include:

• Process definitions and data mapping i.e. when, where and why data are used and what is the impact changes in data or processes

• Roles and responsibilities i.e. who “owns” the information and who uses it • Authoritative source • Technical approach for maintenance and sharing e.g. a central data hub or distributed

access through well-defined real time services Architectures are also addressing both horizontal and vertical information requirements in the enterprise. Horizontal requirements address information flow across functions including regulatory, clinical, pre-clinical, safety, manufacturing and commercial. A horizontal view is essential to supporting the end-to-end management of information through the product life cycle. More than 50% of the 2013 survey participants explicitly included, consulted or informed these functional areas in their regulatory information architecture programs (see Figure 14)

Figure 14 – Functional IA Participation 12


Vertical requirements support information flow between central headquarters, regional and local affiliate users and systems. The vertical view is important to ensure the identification and use of a true authoritative source of information and the reduction or elimination of duplicate data and duplicate systems, especially at the local level. Cloud / Software-as-a-Service Various strategies of cloud computing and software as a service are being discussed. Today most companies support their business processes with software and infrastructure services provided within the company but many are exploring the feasibility of moving regulatory systems such as EDMS, publishing, submission, and registration management to an externally hosted platform at some point in the future. Key questions to be answered include:

1. Who drives a hosting solution: business users or IT or partnership? 2. What is the best hosting strategy? (SaaS + private cloud vs. multitenant cloud) 3. What is the true total cost of ownership? 4. What are the risks and benefits?

Our 2013 survey shows there has been a significant increase in the number of companies investigating (see Figure 15) at least some aspect of using a cloud or software-as-a-service solution since 2011. We have seen a 3X increase in overall activity as measured by product + pilot + investigating since 2011. This increase in activity may reflect user demand for improved regulatory IT services and delivery and industry demand to reduce costs. Cloud deployments are usually expected to provide an improved user experience including improved performance and access. Companies typically expect to reduce the cost of software and hardware upgrades and validation by leveraging standard, shared infrastructure. For this survey, we did not provide a specific definition of cloud since there are a number of models emerging, ranging from traditional hosting to multi-tenant environments, and there are relatively few large scale systems in production. The National Institute of Standards and Technology1 defines the following cloud deployment models, any of which could be utilized by the companies in our surveys:

1 NIST Publication 800-146

Figure 15 - IA Functional Inclusion Snapshot

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• Private cloud. The cloud infrastructure is provisioned for exclusive use by a single organization comprising multiple consumers (e.g., business units). It may be owned, managed, and operated by the organization, a third party, or some combination of them, and it may exist on or off premises.

• Community cloud. The cloud infrastructure is provisioned for exclusive use by a specific community of consumers from organizations that have shared concerns (e.g., mission, security requirements, policy, and compliance considerations). It may be owned, managed, and operated by one or more of the organizations in the community, a third party, or some combination of them, and it may exist on or off premises.

• Public cloud. The cloud infrastructure is provisioned for open use by the general public. It may be owned, managed, and operated by a business, academic, or government organization, or some combination of them. It exists on the premises of the cloud provider.

• Hybrid cloud. The cloud infrastructure is a composition of two or more distinct cloud infrastructures (private, community, or public) that remain unique entities, but are bound together by standardized or proprietary technology that enables data and application portability (e.g., cloud bursting for load balancing between clouds)."

At this time, there are very few vendors offering true cloud services tailored to the support the requirements of regulatory information management. We expect to see an increase in those offerings over the next 2 to 3 years as the demand for global, standard solutions increase and successful cloud implementations are achieved.

Regulatory Information Management Vendor Landscape

The vendor space continues to experience many changes since last year’s edition including several significant mergers and acquisitions and an industry call for “innovation”. As mentioned in our opening remarks: “the pace of industry change is greater than the solution provider’s ability to innovate and this is a growing issue and industry challenge”. We hope the next two years will witness a breakthrough in innovation as vendors rethink strategic partnerships, seek to utilize disruptive technologies applied in other business sectors, and embrace 21st century usability. The following are key trends: Vendor consolidation continues within the regulatory solution space and we expect

further vendor merger & acquisition activity. Larger organizations are buying the smaller “niche providers” as the addressable market for combined services / solutions is attractive

R&D content management and registration management have clear market leaders with several “newcomers” trying to penetrate these markets along with the potential “next generation solutions becoming a reality by 2015.

Submission and resource management vendor market share is predicted to change significantly over the next several years as priority investments in global planning capabilities and resource management will be made in both 2014 and 2015.

Robust RIM capabilities are still maturing and buying cycles are longer due to the strategic nature of vendor/partner decisions

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Dossier outsourcing competition is growing past the traditional players as CRO’s are aggressively pursuing this space. Deals are much more substantial as opposed to just traditional “one-off” projects.

Several vendors are offering cloud solutions; we believe this will mature significantly by 2015

Vendor Satisfaction Snapshot Most categories of vendor solution sets find their satisfaction levels decreasing or just neutral with only one (labeling) showing an increase in satisfaction levels (see Figure 16). Part of this phenomenon can be explained by separating market leaders and non-market leaders where a significant rating delta exists, especially in registration management and submission plan/track. The other key aspect of this grid is the degree of anticipated vendor change over the next two years as many are rethinking their entire RIM capability and looking for more innovative end to end solutions. Document Management (Submission and eTMF)

Since our 2011 market share benchmark, small but significant changes have emerged and we believe the next 2 – 3 years will be very interesting in this space. We are watching the market dynamics closely as traditional document management (submission and eTMF) might just break-through from a “static” 10 years of little innovation. Veeva and EMC D2 are center stage as newcomers bringing an alternative approach (cloud-based) or new options for the traditional approach (application layer over Documentum). We hope these entries force significant vendor investment to substantially improve usability (download app generation), seamless passing of content between organizations, and dealing with the fundamental performance issue that has limited global document management. The next “big wave” is cloud-based with several interesting vendor announcements such as Veeva partnering with Liquent, Extedo, and Lorenz for cloud based EDMS/publishing. While these cross vendor solutions require maturing, we can finally see the end in sight for next generation document management. We are rather perplexed with the eTMF market-share data as our 2011 benchmark showed a tremendous priority in this area and significant investment in technology solutions. The market-share remains static (see Figure 17) while many buying decisions are either delayed,

Figure 16 - Vendor Satisfaction Trending

Figure 17 - eTMF 2013 Market Share - Top 50

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experiencing difficulty, or pilot discontinuation due to vendor issues. We believe the answer lies in Figure 18. The DIA Reference Model provides the structure for the vendors and basic document management features are required along with basic reports (what is open so I can close my TMF). We see the issue in unsatisfactory usability and interoperability. As companies view RIM and their R&D solutions more strategically, they want to ensure clean interconnection between the traditional CTMS and filing systems. Several vendors are based on old technology that does not have attractive usability while several new players have excellent usability, but lack common feature/functions. This is the dilemma of the situation and we hope this will change in the next 12 months; if so, we will probably see a steady market-share shift. Our submission document management market-share saw little change with the exception of additional secondary SharePoint solutions. CSC’s First Doc retains market leadership with a 54% of the market (note that many participants cited multiple EDMS solutions) while customized Documentum is second at 43%. We believe Veeva and EMC D2 are increasingly relevant and will challenge CSCs market domination over the next two years. We continue to track NextDocs to see if they can build on their initial success. We believe the Veeva cloud approach could be a “game-changer” with additional success and evidence this approach could apply to large mid-tier and the top 15; only time and the market will tell. What we find interesting is EMCs DB2 approach that is in direct competition with CSC and other Documentum based vendors. Additionally, both EMC, and Veeva Systems are hiring seasoned industry consultants and/or buying small professional services firms to support this new offering. This raises some interesting questions:

• What does this mean for CSC and its relationship with EMC? (friend or foe)

• Has EMC entered this market too late or is it perfect timing for customers who are frustrated with current solutions and not likely to switch to a true cloud or SharePoint based approach?

• Will SharePoint be able to scale to gain market-share from Documentum based solutions?

• Can Veeva breakthrough to large top 15 multi-national clients?

Figure 18 - eTMF Capability Breakdown

Figure 19 - Submission EDMS 2013 Market Share: Top 50

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Publishing

Publishing vendors’ market-share has seen little change (see Figure 20) over the past 3 years and we expect this to continue. Companies are busy applying continuous patches to keep up with evolving electronic standards in different countries (e.g. Saudi Arabia - eCTD) and causing re-validation of systems. We expect this to continue as the regulatory environment is getting more complex outside the EU and North American markets. The most significant growth will be in the services side as many vendors are projecting growth of 30 – 50% as more companies adopt or expand partial or full dossier outsourcing. As stated in our 2012 paper, “the momentum is significant and a key question for service vendors is one of organizational scale. With a significant increase of business, how can their organizations scale effectively AND keep quality and turn-around times equal to customer expectations”. We believe Accenture/Octagon, Parexcel/ Liquent, CSC/ISI, and several large CRO’s to be the main players moving forward. We find that large organizations prefer a global outsourcing partner that can combine regulatory, clinical, and other value-added services. Global Product Registration and Submission Management

This area continues to experience significant activity with Liquent the clear market leader and gaining share since our 2012 review along with ArisGlobal making a strong resurgence. Several organizations will make vendor decisions late 2013 and 2014 and we expect the market-share story to evolve with much of the “internally developed” (see Figure 21) shifting to off-the-shelf (OTS) solutions. Liquent continues to build on their strength and we believe they will be the market leader for the foreseeable future. CSC, Mission3, Accenture/Octagon are investing and pushing hard to gain industry relevance and still have a shot at gaining market-share with many internally developed solutions aging and in need of investment or switching to industry-standard solutions. The submission management space is very interesting as companies see this as either an “add-on” to their publishing or product registration capability or a separate solution set. The business goal is often the lens that brings different vendors to center stage. Is one looking at the global submission portfolio (forecasting) or is it more operational in nature (submission plan and operational measures)? Liquent, Planisware, and Accenture/Octagon are the current players in this space and we do not expect this to change in the foreseeable future.

Figure 20 - eCTD 2007 - 2013 Market Share

Figure 21 - 2008 - 2013 Market Share

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We believe that looking at product registration management independent of the overall regulatory information management picture is shortsighted. Companies need to determine their overall RIM strategy and be very intentional in their adoption of a “niche” or “information integrated” strategy. Registration tracking, submission planning, approval status and analytics, and product information are core to any RIM capability. Health Authority Interactions (Commitments, Q&A, Correspondence)

This by far is the fastest growing area in both operational and strategic value. Most companies are in process of improving commitment programs to understand the current “work-in-progress” status and understand if any risk exists in outstanding commitments. We see this information progressing to public transparency in the near-term. Health Authority questions and answers tracking and global sharing to ensure response consistency are also common projects. While we have market-share for the first time, we are not publically publishing it as most companies utilize multiple tools for each activity centrally, regionally, and locally without any consistency. We expect this to change in the near-term with so much priority on end to end RIM solutions that typically cover these areas. We have conducted internal surveys that inventory frequency of tools used (complexity), time in tools or managing information (efficiency), and the value to move to common global tools since our last edition and found significant complexity along with tremendous opportunity to consolidate the environment. Labeling

Although this area has remained relatively static since EMA’s announcement to cancel the PIM program; this is starting to change. There is significant focus on two areas (see Figure 22) surrounding Core Data Sheet utilization and label submission and approval status. Market-share remains similar to 2011 levels with the traditional software players (Glemser, i4i, Reed, Microsoft WORD, and Abortext). With the impact of the PIM program cancelation fading, most companies are looking to improve the efficiency of their label organization and are starting to invest in technology solutions once again; mainly in the component authoring and tracking areas. Finally, we expect several of the niche players to be bought over the next two years as larger vendors seek to expand their RIM offerings and are missing this vital piece of the RIM puzzle.

Figure 22 - Label Program Priorities

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Conclusion: Parting Questions 1) Do you have the right RIM foundation to better address growing strategic requirements and

to reduce cost over time?

2) Will you need a different Data Governance approach and model to achieve a true authoritative source?

3) How can industry collectively push innovation with the vendor community?

4) How will you incorporate continuous improvement methods and effectively monitor performance measures?

5) What is your RIM orientation and how does this influence your vendor interactions? Gens and Associates Inc. Benchmark (Red = Referenced for this edition)

1) 2007 eCTD/Electronic Document Management Survey, (with ILSS) 2) 2007 Promotional Material Process Metric 3) 2007 Labeling Pulse Survey 4) 2008 eCTD and Organizational Implications 5) 2008 Labeling Best Practices Survey 6) 2008 Regulatory Core Dossier Submission Strategy 7) 2009 Electronic Document Management/Collaboration (with ILSS) 8) 2009 Industry Engagement 9) 2009 Regulatory Submission Management and Production Planning 10) 2010 Global Pharmaceutical Regulatory Affiliate Strategy 11) 2010 Regulatory Information Management & Health Authority Trends 12) 2010 Vendor Market Share Update 13) 2011 Collaboration and Content Management Trends (with ILSS) 14) 2011 Regulatory Futures 15) 2011 Publishing and Dossier Management (organization and outsourcing) 16) 2011 Labeling and Promotional Material Organization Strategy 17) 2012 Regulatory Information Management Trends 18) 2012 Vendor Market Share Update 19) 2013 Managing Regulatory Information as a Corporate Asset (n = 37) 20) 2013 Regulatory Operations Pulse 21) 2013 CTA Pulse 22) 2013 EDMS and Digital Archive: One in the same? White Paper Authors

Steve Gens has 27 years of business experience with the majority in the biopharmaceutical and healthcare industries. His early career was spent at Johnson and Johnson and then moved into consulting where he managed several healthcare consulting practices for Booz Allen Hamilton and First Consulting Group. Steve has deep experience in strategy formulation and implementation, organization development and performance, global virtual team effectiveness,

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industry benchmarking, information management strategy, and leading or facilitating strategic change. He consults for many of the largest global biopharmaceutical companies and also with small high growth organizations. Steve has a Master of Science in Organization Development, Bachelors of Science in Business Computer Science, and is certified in Change Management from the NTL Institute of Applied Behavior. President of Gens and Associates Inc. [email protected] or 267-614-0935

Greg Brolund is a Global Pharma management and technology consultant with extensive experience in business processes and supporting IT for product labeling, submission publishing, Health Authority interactions, pharmaceutical safety and pharmacovigilance programs. He served as the Rapporteur of the ICH M2 Working Group Rapporteur from 1998 through 2002 for the development of the initial production version of the eCTD and the implementation of the E2B ICSR

electronic submission. He has 25 years of experience with the FDA leading development of FDA’s internal IT systems in support of the CDER and CBER submission review process. After leaving the FDA, he served as the US HHS CTO and was a pharmaceutical industry consulting with Booz Allen Hamilton. He holds a Masters of Chemistry degree from the American University in Washington DC.

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mailto:[email protected]

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