Clinical-Trial Management June 2006 VIEW on Clinical Services The Critical Need for Clinical Performance Management Bill Stevens Senior Director, Life Science Industry By investing in performance management software, organizations can leverage clinical information to better manage the drug-development process. Pharmaceutical companies are under intense pressure to deliver new drugs in record time. Yet the reality is that drug research and development is expensive, lengthy, and increasingly regulated. To optimize performance, pharmaceutical companies need insight into all aspects of the clinical development process. Pharmaceutical clinical trial managers need to review what’s working, what’s not, and respond accordingly. And gaining that insight depends on having complete access to clinical information across the entire organization. One way to achieve this knowledge is through clinical performance management software, which integrates clinical data and delivers the business intelligence and planning tools to leverage this information for better performance. Leveraging Valuable Data ERP, EDC, CTMS, and other operational systems generate huge volumes of data. But these systems are largely departmental or tactical deployments, generating disparate sources of information. For operational efficiencies, it’s now critical that pharmaceutical companies integrate these data to gain a common baseline for managing the clinical development process. Performance management software consolidates clinical data and leverages the information through reporting, analysis, and metrics. The benefit is a comprehensive view — schedules, budgets, goals met, and goals unmet. With this insight, clinical trial project managers and other company executives can make decisions that not only solve immediate problems, but improve clinical trial performance over time. In terms of compliance requirements, such as the Food and Drug Administration’s CFR 21, having timely access to all clinical data is essential. With an integrated platform, managers and stakeholders work from a single source of risk and financial information that is consistent and auditable. The Benefits of a 360-Degree View One of the advantages of an integrated performance management framework for managers is the ability to look across all areas that impact drug development. These insights ultimately lead to a leaner, more efficient environment. A clinical scorecard, for example, pulls together clinical trial, clinical operations, financial, and regulatory data from different systems. Trial managers can then drill down to the “why” behind the results. If patient recruitment is tracking behind in a particular program, by clicking on the scorecard, a manager can quickly link to a report to see the sites affected by this issue. Another key benefit of a scorecard is that the organization can align performance metrics with strategic objectives and targets. People are able to measure results and gauge how the strategy is succeeding. And, through integration with planning, targets can be recalibrated in response to changes in performance. Planning and Budgeting Leads to Greater Effectiveness Many pharmaceutical executives and project trial managers admit they have no idea of the true cost of clinical development. This is because the traditional planning process, involving annual budgets and infrequent adjustments, often relies on guesswork instead of certainty. Enterprise planning software replaces a fragmented process with continuous, collaborative planning. The organization defines goals, and turns them into discrete plans and budgets for the entire clinical team. Plans can be created to maximize operational effectiveness and better anticipate resource requirements and expenses. And they can be realigned as conditions change. Better Information For Better Decisions Today there is a critical need for clinical management oversight. Clinical performance management software leverages all of an organization’s data to present a complete picture of the drug development process. A consolidated view allows stakeholders to quickly determine how the organization is doing against established milestones, identify and isolate problems, and take the appropriate steps to address the issues. The insights gained from this analysis allows pharmaceutical, biotechnology, and drug device companies to gain efficiencies, streamline operations, and reduce the costs of bringing new products to the market. Clinical Performance E-Survey In April 2006, PharmaVOICE conducted an e-survey of pharmaceutical companies to gather data on issues impacting clinical performance. The survey, sponsored by Cognos, included respondents from many segments of the industry, including top 50 and midlevel pharmaceutical companies, as well as biotech companies and start-up companies. Highlights of the e-survey responses include: • Confidence in current performance management practices. Only slightly more than one-quarter of respondents expressed great confidence in the ability of current practices to help their companies achieve and sustain a competitive position over the next five years. When asked why this was so, they pointed to a number of factors, including lack of funding, organizational issues, and difficulty in facilitating change. • Top barriers to achieving clinical research objectives. The main areas cited were recruiting patients, insufficient resources, managing effective outsourcing relationships, and spotting trends that might impact trial progress. • Factors that would increase the effectiveness of internal systems. To improve the effectiveness of systems supporting clinical programs, many respondents pointed to easier and faster self-service data access, reports, analytics, and visibility of information residing in multiple systems. Other factors included more responsive support, and the ability to share information with CROs and other external partners. Capabilities That Would Increase Effectiveness of Internal Systems Data Access Self Service Internal Data Share Responsive Support External Data Share Visibility Better Training Areas Where Metrics Are Used to Evaluate Clinical Research Performance Cycle Times Patient Enrollment QA Study Duration CRO Performance Costs/Budget Site Productivity Filing Speed• Lack of real-time, actionable information • Securing accurate information on cost of trials against plan • Ability to spot trends, bottlenecks impacting trial progress Source: PharmaVOICE April 2006 E-Survey. For more information, visit cognos.com/pharma_learn. Greatest Barriers to Achieving Clinical Research Objectives Confidence in Current Performance Management Practices for Competitive Advantage Visit the Cognos Pharmaceutical Resource Center at cognos.com/pharma_learn to download full results. Cognos, Burlington, Mass., is a leader in business intelligence and enterprise planning software; solutions for performance management let organizations drive performance with planning, budgeting, and consolidation; monitor it with scorecarding; and understand it with business intelligence reporting and analysis. For more information, visit cognos.com/clinical.

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