Creating a Roadmap to Clinical Trial Efficiency

Value Envisioned. Value Delivered.

Clinical Trial Management: Maximizing Existing Assets

Clinical trial management is becoming ever more complex. In order to meet the challenges of today and those of tomorrow, clinical trial management processes must evolve. Fortunately, evolution does not equate to vast new technology systems. In fact, many companies already possess the key pieces of technology required. Improvements are simply a matter of leveraging those technology capabilities more effectively.

Executive Summary
Managing a clinical trial of any size and complexity requires efficient trial management. Yet for the past three decades, life sciences companies have built and then continuously added to inefficient processes, often cobbling together critical system support functions. At the same time, the business environment and regulatory factors have made the clinical trial landscape progressively more complex. A focus on outsourcing partnerships, in addition to a significant number of mergers and acquisitions over the last 10 years, has added to this complexity. In 2011 alone, despite uncertainties on both economic and regulatory fronts, over $200 billion in healthcare related M&A deals were announced.1 Simultaneously, health authorities are demanding better, faster disclosure of data. In September 2012, the U.S. Secretary of Health and Human Services delegated its clinical trial monitoring authority to the U.S. Food and Drug Administration (FDA). Though the full implications of this change are not yet known, increased GCP inspections and more stringent compliance requirements are
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expected. Drug development teams are also faced with ensuring smart strategies for the emerging challenges, including mobile health, social media, electronic health record data, genomics information and the tsunami of big data. In order to meet these challenges, life sciences companies must improve the efficiency of internal clinical management processes, reduce manual reporting and human intervention, and provide better visibility across the clinical trial landscape. Conducting a clinical architecture assessment allows companies to get a full picture of see what current systems and processes they have, understand what is working, and more importantly critically identify the gaps of what is not working and what is missing. It provides the team with a path roadmap forward to synchronized improvement in both improving their systems and their operations, enabling effective change in the near and long term. When these two facets of systems and operations are optimized and in sync, the resulting improvements are greater than the sum of optimizing each individually.

Healthcare and Life Sciences Group, Mergersand Acquisitions, 2011 Year in Review, Sullivan & Cromwell LLP, http:/www.sullcrom com/files/upload/Healthcare

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Introduction
Developing a drug, biologic, or device is a costly undertaking. On average, the drug development process takes more than 10 years and $1 billion dollars.2 About 85 percent of therapies fail in early clinical trials, and of those that survive through to the last step before regulatory approval, only half are approved.3 (see figure 1) But success is not solely dependent on the quality of the investigational product. Experts suggest a significant number of high viability products are being lost to outdated and impractical clinical trial designs and the lack of a streamlined, integrated approach to trial management. The high numbers of mergers and acquisitions that have taken place in the industry have played a significant role in creating dysfunctional trial management processes. Clinical trials, under any circumstances, involve a tangle of players and systems. But as M&As occur, the companies involved often inherit a mix of disparate technology and clinical trial business processes in addition to their own. Rather than use the changing business environment as an opportunity to holistically review and integrate such processes and systems, many companies manage the new jumble of disjointed processes and systems as best they can. Meanwhile, a number of external pressures challenge the feasibility of clinical trial business as usual. The economic landscape has changed dramatically in the last 10 years. Life sciences companies no longer generate the high levels of revenue they commanded in the early 2000s. Not only are they faced with increasing throughput to stay solvent, in many cases they have been forced to reduce headcount as well.
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7.5%

15%

85%
85% of All Drugs Fail During the Development Stage 15% Survive Development 7.5% Make it to Approval

Figure 1

The evolving and multifaceted landscape of compliance requirements adds additional strain. For one example, global health authorities such as the FDA now require companies to submit public data about ongoing and past clinical trials. However, a 2012 analysis of the FDA data set on clinical trials found that much of that data is missing. In fact, only 22 percent of completed trials reported results within a year, as required.4 Given the increasingly challenging business and regulatory environment, life sciences companies must evolve their clinical trials processes and improve efficiency with fewer resources.

Translational Research: 4 ways to fix the clinical trial, Nature.com, September 2011, http://www.nature.com/news/2011/110928full/477526a html 3 Translational Research: 4 ways to fix the clinical trial, Nature.com, September 2011, http://www.nature.com/news/2011/110928full/477526a.html 4 Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study, BMJ Group, January 2012, http://www.bmj.com/content/344/bmjd7373 pdf%2Bhtml

Value Envisioned. Value Delivered.

Clinical Architecture
Develop Clinical Strategy Register Clinical Studies Indentify, Assess and Select CROs Study, Planning and Design Study Initiation/ Startup Patient Recruitment and Enrollment Study Monitoring and Conduct Study Management Study Data Collection and Management Study Output and Closeout Study Reporting and Analysis Disclose Study Results Investigator Portal Project Management System Clinical Trial and Results Registration System Grants Management System Clinical Data Management Statistical Analysis Tool Clinical Trial Management System Investigator Database Risk Identication and Management Adverse Event Capture Adverse Event Data Entry and Coding Adverse Event Reporting System Submit and Negotiate IND Safety System SPL and PIM

Pharmacoviligence

Medical Evaluation Periodic Regulatory Reporting Expedited Adverse Event Reporting Signal Detection Develop Risk Evaluation and Strategy Adverse Event Reconciliation Trending

Regulatory Affairs

Develop Labeling

Labeling Management System

Safety Data Warehouse

Manage Labeling Clinical Trial Disclosure

Submit Labeling

MeDRA

Submit and Negotiate NDA Safety Data Reconciliation Tools

Submissions Document Management

Envisioning a Better Model

Clinical trials are not only complex to accomplish, there is also a large variance between trials. As a result, business processes and systems are challenged to support and scale, and technology solutions are often introduced as a point-intime fix, which results in additional complexity or redundancy. Often, a lack of understanding of interfaces between application portfolios and functional areas exists, and systems are not strategically integrated. Ultimately, knowledge is not consolidated, easy to access, or reusable. The technology landscape of a typical life sciences company includes a large variety of system capabilities and vendors, which continue to push the feature sets they support for a given user role or business process. In clinical systems alone, where once there was just Clinical Trial Management Systems (CTMS), Clinical Data Management Systems, and electronic Data Capture, today a host of capabilities such as electronic Trial Master Files, external collaboration/Investigator
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Portals, Interactive Voice Response Systems, and electronic Patient Reported Outcomes systems exist and must integrate into the larger clinical architecture and capabilities. This onslaught of systems presents challenges on two fronts: information does not flow appropriately between systems and business processes, and the company often operates using a patchwork of systems and process functionalities. Managing this scenario on a day-to-day basis can equate to what a computer programmer might deem a hack on top of a hack. The approach may provide the data the company needs to get through the day, but it provides little assurance as to the quality of the data or the long term reliability of the systems throughout the clinical development program. For example, a company without a solid grasp on their master data management architecture may have different users entering critical trial management data points in conflict in two or more

Companies need to anticipate the impact of industry changes and enable transformation to a more agile, integrated enterprise while strategically eliminating unnecessary or redundant systems and reducing operating expenses.
systems. Not only is this duplicative and error prone, but it creates a situation where authoritative data is not available for decision making and reuse. Such processes are often conducted by lower level employees who are completing their work to the best of their abilities, and who may not understand the downstream implications. At the same time, tactical technology solutions make understanding application portfolios and interfaces difficult. Companies often build-out ancillary capabilities in their tools, which can lead to systems with overlapping but disconnected feature functions. This means it is often difficult to stitch everything back together to obtain a global or product level view across a study. For instance, a manager cannot easily ascertain project status and so devotes significant non-value added time to answer questions for senior management. Just-in-time data is not easily mined to identify risk signals that require review, analysis and potential corrective actions. Not only does this complexity present challenges within the company, but as clinical trials have become more collaborative over the last several years, involving two or more companies in outsourcing or co-development relationships, proprietary ad-hoc processes and data inefficiencies become joint sources of complexity and risk. As the FDA takes over drug trial monitoring responsibilities from the U.S. Department of Health and Human Services, they are pushing for higher

levels of visibility and for obtaining data about clinical trials on an interim basis throughout the study rather than only at the studys conclusion. The FDA is also beginning to emphasize system level inspections rather than trial level inspections. An FDA inspection of a companys monitoring process for a program with several trials could potentially expose a broad range of process and data inconsistencies. Today, life sciences companies no longer have the financial or personnel resources required to make systems and processes work using brute force alone. Instead, fundamental changes to clinical trial systems are needed. Business processes and systems must evolve to support, scale, and improve efficiencies. Companies need to anticipate the impact of industry changes and enable transformation to a more agile, integrated enterprise while strategically eliminating unnecessary or redundant systems and reducing operating expenses.

Building the New Trial Management Architecture

Fortunately, a more efficient, manageable, and maintainable trial management process is possible. But simply adopting new clinical management technologies and forcing business processes to conform to the systems capabilities will not achieve the goal. Instead, the company needs to first understand the flow of activities and data across the business processes, and be willing to rethink the process steps necessary to remain compliant with GCP and local regulations. Effectively assessing and depicting the current state of the clinical architecture environment, defined as the ecosystem of system features, capabilities, and data that support the overall Clinical Trial Management business processes, is an ideal starting point. First, model the current

Value Envisioned. Value Delivered.

state by defining the business capabilities needed to conduct a clinical trial. These include activities such as site monitoring, project management, supplies management, content management, and site interactions, for example. Some activities are functional and will stretch across multiple processes, while others are specific to a given process. For example, clinical trial processes result in regulated content that requires control, so content management is a core process that would be mapped to multiple business processes. Once business processes are identified, examine how data moves through the process. Which business processes are most manually intensive? Where do hand-offs occur between roles? Finally, define the user communities and the information they require to support business processes. Define the data users need, which systems and business processes they must interact with, and determine the most efficient and cost effective way to provide that data. Next, map findings back to current scenarios and determine priorities. What are the most critical capabilities? If content management affects 60% of the processes and is also manually intensive, for example, it is assigned a high impact score. Evaluating what the business can handle from a change standpoint is also taken into consideration. Determine which parts of the business are most open to transformation and tie that into the prioritization. In other words, just because content management is high on the capability priority list does not automatically mean it is the right choice for the business today. All project dependencies must be considered before prioritization is complete. As dots are connected, a roadmap begins to appear, and the processes emerge that need to be examined and re-engineered most urgently. From here, the company can take action on an implementable, practical capability roadmap.

Conclusion
Without thorough insight into current processes and technologies, a company cannot effectively change the current state or be prepared for a dynamic future state. A clinical architecture assessment delivers insight into applications and their interface with business/operations processes. It s and provides a dynamic, graphical view into the current portfolio of systems and delivers . Additionally, it provides visibility into potential bottlenecks, demonstrating how data moves through a diverse application portfolio, and shows how proposed changes to the flow affect all areas of clinical architecture. Finally, a roadmap provides a manageable, structured path to improvement that is feasible in the current environment, enabling transformation to a more agile, integrated, and compliant enterprise and allows for the strategic elimination of unnecessary or redundant systems to significantly reduce operating expenses. In addition concert with IT improvements, the to improving the IT side of the equation, following the roadmap helps ensure that the business/operations team is operating within a framework that puts them in a position to succeedbeing more efficient and delivering results today, and prepared for the changes to come in the clinical trials of tomorrow.

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About Paragon Solutions:

Paragon Solutions is an advisory consulting and systems integration firm that specializes in enterprise information management to help clients leverage information assets for better business results. The company does this through its industry practices, solution accelerators and specialized technology competencies that help clients achieve operational efficiency, business scalability, and regulatory compliance. Paragon works with businesses that are focused in a few key industries communications, financial services, healthcare, insurance, and life sciences. The industry-focused practices work with Paragons competency groups to address todays client concerns in Process Optimization, Information Management, and Information Insight. For more information, please visit the Paragon website at www.consultparagon.com, or call 1.800.462.5582.

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