The Whole Product An Integrated Approach to Evaluating & Selecting a Clinical Trial Management System

The Whole Product An Integrated Approach to Evaluating & Selecting a Clinical Trial Management System Summary For institutions, deriving real value from investments in a clinical trial management system (CTMS) requires longterm vision and carefully honed selection criteria. The evaluation and selection process can be enhanced by utilizing a technique known as the Whole Product approach. The Whole Product approach, in this context, looks at the entire ecosystem that is created by the technology, its adoption within the research institution, and the technology provider. Aspects of this approach encompass: (1) the current product, (2) release management, (3) training, (4) adoption, (5) integration, (6) community, and (7) innovation. Part One of this document outlines the general principles of the Whole Product approach for selecting a CTMS in support of research operations. Part Two illustrates how Forte Research Systems has adopted the Whole Product approach to help institutions implement, utilize, and extract maximum value from the Allegro systems. Revision Date: May, 2012 M00027-0512

PART ONE: The Whole Product Even the world s greatest technology is just a starting point in a much larger ecosystem that is sometimes referred to as the Whole Product. For institutions to derive real value from their technology investments there are many considerations that need to be addressed, each of which call for nontrivial amounts of focus, dedication, and resource commitment from the vendor as well as the institution. The following provides key questions and a brief discussion of these important considerations, grouped into the major areas shown in the diagram at right. Part Two of this document provides details about how Forte addresses each of these different areas. Current Product Current Product refers to the currently available functionality of the software. The key question here for institutions: Does the existing software functionality provide adequate coverage of your institution s mission-critical needs, as well as its high-priority requirements for the near future? Innovation Successful software adoption and use is an ongoing process that is never truly complete. How will the system continue to evolve to keep pace with your institution s changing needs? How will innovations from you and other members of the user community get included in newer versions of the software? How will changes in regulations or industry standards be incorporated as the software evolves? Release Management Release Management encompasses Release Plans, Requirement Prioritization, Change Management, Quality Assurance, and Software Deployment. Does the software vendor have well-defined plans, management controls, and a track record of good performance? Additional, relevant questions are: z Does the software provider have regular release schedules to address timely resolution of major and minor bugs, and new requirements? z How are new requirements prioritized and assigned to releases? z How well are new requirements originating from changes in regulatory requirements, science, etc., addressed? z What mechanisms are in place to ensure that new requirements are addressed while not introducing new problems into the existing functionality? z What mechanisms are in place to ensure that the software performs as specified and provides a consistent user experience and dependable performance? Fig 1. The Forte Research Systems Whole Product Approach z Are there well-defined processes and mechanisms in place to ensure that the initial software installation and ongoing upgrades are correctly and completely deployed? Training Does the software provider have proven mechanisms for initial and ongoing training and education, to ensure that users have a solid understanding of the capabilities and intended use of the software? Additionally: z Is there a field-tested training plan with adequate training events for the institution s administrators and users? z What training tools (such as documents, exercises, and multi-media tutorials) are available to software users? z What mechanisms exist to ensure continuous user education? Adoption Are plans for initial software implementation and subsequent rollout, and mechanisms for ensuring the adoption and active use of the software, in line with your institution s goals and priorities? The relevant questions are: z Is there a well-defined and proven implementation plan and adequate project management tools to ensure a successful initial implementation? z What is the vendor s track record in customizing the implementation plan to meet institution-specific goals, priorities, and operational nuances? z What is the vendor s track record in delivering on-time and on-budget implementations? 2012, Forte Research Systems, Inc. Page 1 of 8

z What is the vendor s track record in delivering on-time and on-budget implementations? z Does the vendor offer any help, beyond the initial implementation, with adopting additional functionality or with rolling out the system to additional groups throughout the institution? z Is it easy to learn what functionality other institutions have adopted and what their operational experience has been? Integration In the context of the existing technology investments of the institution, does the software have the required capabilities, and does the provider offer the needed services, to interface with your institution s existing internal systems? Another very important aspect to understand is the vendor s willingness to adopt standards and to interface with external entities such as other technology providers, including competitors. Community Are you entering into a one-to-one relationship with the software provider, or would you become part of a larger community? It is also important to understand what mechanisms exist for the user community to interact, the types of interactions available, and the value that is expected to be derived. More specifically, is it just a user group which occasionally meets to discuss software change requests? Or, does the community provide opportunity for discussing operational issues that would help address non-technology related challenges? PART TWO: Forte Research Systems, and the Allegro Clinical Trial Management Systems Founded in 2000 and headquartered in Madison, Wisconsin, Forte Research Systems, Inc. develops and markets clinical and translational research management software. The company s flagship product, OnCore, is the nation s most widely adopted clinical and translational research system among academic health centers, research hospitals, and cancer centers. Leveraging its expertise and leadership in that space, Forte has designed a family of clinical trial managment systems for investigator sites, investigator site networks, and site management organizations. The result is the Allegro product family, a proven, effective, and sustainable informatics solution that supports streamlined clinical research operations. The system is powerful and secure while providing the flexibility required by individual organizations to support a variety of clinical trial operations. The following information describes how Forte addresses the various facets of the Whole Product concept. The Whole Product: Current Product The Allegro Research on Demand family of products offers comprehensive cloud-based clinical trial management systems. The Allegro products feature two distinct systems: CTMS@Site and CTMS@Network. Each Allegro product is designed exclusively for the user community for which it is intended. Allegro CTMS@Site for Investigator Sites and Research Groups Allegro CTMS@Site is built for clinical research operations excellence. As a cloud-based application, Allegro CTMS@Site requires no software installation and has no hardware to maintain. It provides real-time visibility into a site s entire portfolio of clinical trials with its user-centric, intuitive interface that is easy to use, virtually eliminating the need for training. A list of the CTMS@Site functionality and a brief description of each is presented in the following table. Page 2 of 8 2012, Forte Research Systems, Inc.

Allegro CTMS@Site Functionality Protocol and Subject Life Cycle Management Protocol and Subject Calendar Management Patient Reimbursement Cards (U.S. only) Budget Negotiations & Study Viability Study Financials Management Patient Recruitment Registries Drug Accountability Supply Inventory Management Business Development Dashboards and Custom Reporting Technology Description of Functionality From tracking pre-study activities and IRB reviews to viewing enrollment statistics and treatment assignments, Allegro CTMS@Site keeps you in charge of your studies. Subject management is easy with all steps from registration and consent through the tracking of screening failures and adverse events at your fingertips. Calendars maintain study parameters including treatment schedules, schedule of assessments, and planned procedures by visit. Subject-specific calendars are automatically generated to provide subject visit tracking which directly drives financial management functionality to help ensure accurate and timely billing. Automated debit card creation, issuance, and recharging from within Allegro clinical trial management systems. This integrated approach means management of payment amounts after visit completion is easy. The cards are redeemable at ATMs, retail outlets, and grocery stores anywhere a credit card is accepted, making the whole process simple and easy to implement, just like Allegro. A 6-step wizard assists with the creation of comprehensive budgets. The resulting estimation of costs provides insight into study viability and is a powerful negotiation tool for discussions with sponsors. Invoices based on occurred or monitored visits are easily created and expected payments are tracked. Reconciling sponsor payments, tracking outstanding invoices, tracking sponsor withholding amounts, and revenue forecasting are all made simple. Streamline your sponsor and investigator payments and patient stipends through automatic calculations and simplified reconciliation. Easily identify subjects in your patient population who might qualify for a new protocol, filtering by patients medical conditions in addition to any custom-defined screening questions. Automated calculations assist with ordering, receiving, dispensing and accounting for drug kit use. Drug accountability compliance percentages per subject are calculated with minimal data entry. Manage inventory of lab kits and other study supplies and equipment with precision. The quantity on hand is automatically updated as visits occur. This, combined with the ability to set reorder thresholds, allows orders to be placed proactively. Your entire list of sponsors, CROs, and contacts may be managed in the system. Activity related to a sponsor is tracked and documents may be attached for easy reference. Get immediate visibility into the health and progress of all of your studies at a glance using the built-in reporting tools. A rich collection of standard reports and default dashboards are immediately accessible. 2012, Forte Research Systems, Inc. Page 3 of 8

Allegro CTMS@Network for Site and Trial Management Organizations and Investigator Site Networks Allegro CTMS@Network is a cloud-based application built for network organizations to successfully manage clinical trials across multiple sites, a task that involves numerous requirements associated with demand generation, site selection, study start-up, and project management. Allegro CTMS@Network provides information about individual sites and across multiple sites in an easily accessible format. In addition, it assists network organizations with finding and selecting appropriate sites, and in working toward study start-up. These capabilities support streamlined site selection, timely study start-up cycles, and up-todate tracking of protocol activity. Only Allegro CTMS@Network provides a solution tailored to the unique challenges faced by network organizations. A list of the CTMS@Network functionality and a brief description of each is presented in the following table. Functionality Direct Visibility into Study Conduct Across Sites Centralized Calendar for Time Management Patient Reimbursement Cards Demand Generation Investigator Site Database Site Selection Capability Task Management Tools Dashboards and Custom Reporting Technology Allegro CTMS@Network Description of Functionality Get a birds-eye view of the progress of all of your protocols across all sites in one place. Utilizing functionality created exclusively for sites, study conduct is made simple and actually helps sites manage their operations with easy one-time calendar setup and visit tracking, including auto-populating planned dates. Manage site visits and internal meeting invitations using the centralized calendar on the home page. Create invites for internal meetings by viewing each user s availability, and integrate your events directly with Microsoft Outlook if desired. Automated debit card creation, issuance, and recharging from within Allegro clinical trial management systems. This integrated approach means management of payment amounts after visit completion is easy. The cards are redeemable at ATMs, retail outlets, and grocery stores anywhere a credit card is accepted, making the whole process simple and easy to implement, just like Allegro. Track business development progress in your work with sponsors and CROs, including all pertinent contact information and activities related to acquiring new trials. Integrate tasks and events related to accounts directly within your home page to help manage your time. Get a clear view of all your investigator sites in one place. Track information about your investigators and sites at the appropriate level while eliminating any duplicate tracking. Manage investigator credentials, including expiration dates, and upload current licenses only once even when working with several sites. A single search engine finds matching criteria from sites, allowing you to quickly find matches that meet trial requirements. Trials are tracked throughout the siteselection phase, allowing quick access to appropriate sponsor, CRO, and site contact information. Use task lists to plan more proactively for activities between the network and the site for faster study start-up times at sites. Standard task list templates are created at your organization, providing task and timeline defaults for your investigator sites on a protocol, while allowing you to customize as needed. Task lists are tracked per investigator site on each protocol and auto-populate target dates based on the template timelines that have been defined. Tasks will automatically appear on the users home pages for those tasks that they own to help staff be proactive and manage all investigator sites effectively. Easily and quickly view metrics across all protocols and all investigator sites. Flagging tasks as milestones allows you to report effectively despite the unique needs that may exist at each site and for each trial. A rich collection of standard reports and default dashboards are immediately accessible. Page 4 of 8 2012, Forte Research Systems, Inc.

The Whole Product: Innovation Forte has established a strong collaborative relationship with its customers and has demonstrated its ability to develop and enhance software that is quickly adopted. Two keys to the Allegro system s success are the way in which it has been developed and the way in which it continues to evolve. As the customer base for the Allegro product line grows, so does the company s ability to address a variety of needs that arise before, during, and after an implementation. Forte believes that its approach of innovating through collaboration is essential to understanding its ability to serve its customer base, and that this is responsible for the consistently high levels of satisfaction that its customers report. Allegro software is the result of numerous close collaborations. Through shared understanding of common challenges and community-driven priorities, it continues to evolve to keep pace with the changing needs of clinical research, thereby providing a solution for today and tomorrow. Collaborative Initiatives and Partnerships In addition to collaborating with the Allegro user community, Forte partners with industry associations to raise standards and promote excellence in clinical research operations. One such initiative involves the use of metrics among sites to improve industry performance. Forte has joined the steering committee of an initiative launched by the Metrics Champion Consortium, which promotes standardized performance metrics across sites to improve operations. The company continues to enhance collaboration among users and the industry at large, believing that is the cornerstone to the products success and continuous improvement across the clinical research industry. The Whole Product: Release Management Release Plans As represented in Figure 2, the Allegro system versions are delivered through three types of distributions: Major Releases, Minor Releases, and Patches. Major Releases: Major releases are the primary means of delivering new features and functionality to the installed base and to new institutions. Major releases are thus distributed to all institutions and are scheduled quarterly. Any system architecture changes or software changes that require user training are scheduled for major releases. Major releases are typically rolled out to all institutions as quickly as possible and never require down time, ensuring no burdens are placed on the workflow of institutions. Minor Releases: Minor releases are bundles of software bug fixes that are made available between major releases. They rarely occur, but in the event of a minor release, Forte will provide release notes that describe the set of bugs and repairs. When critical bugs are fixed that affect all customers, it will be rolled out in a similar fashion as major releases. Patches: Patches are unscheduled software updates made in response to critical issues requiring an immediate repair. The quality assurance and control systems of Forte are designed to minimize the need for such patch distributions. A patch Facet Major Patch Bug Fixes Enhancements New Features Collaborative Development System Architecture Changes SOMETIMES Training USUALLY Scheduled in Advance Deployment Plan ALL CUSTOMERS Only the affected site Fig 2. Allegro Software Distribution Release Management 2012, Forte Research Systems, Inc. Page 5 of 8

contains only changes required to repair the critical issue and thus never contain enhancements or new features. Requirement Prioritization There are many sources from which requirements arise and it is not possible to address all the known requirements in a given release. Given this, there is a need for a framework for prioritizing the requirements. The following are some of the sources, in order of their relative priorities, that Forte considers when making these decisions: z Bug fixes z Customer change requests: Prioritized based on the number of customer requests and the overall impact on workflow z Industry changes such as regulatory requirements and emerging market needs: Regulatory requirements (e.g., HIPAA, CMS, 21CFR Part 11) z Collaborative initiatives z Internal requests: Forte is actively engaged with the workflows of the users, recommending adjustments to the Allegro systems to support more streamlined processes at institutions Change Management To ensure that software changes are appropriate, relevant, and will not create issues for users, Forte has processes and tracking tools in place. A change control process ensures that changes are introduced in a controlled and coordinated manner. This serves to eliminate changes that are unnecessary, might conflict with existing or planned functionality, might undo previous changes, or might introduce faults. An issue tracking system is employed to manage issues reported by customers, internally reported issues, and requested changes or enhancements. The system tracks issues and changes along with their changing status from their initial identification through to resolution and is an essential tool in the change management process. Another essential change management tool is a revision control system used to manage changes to source code and documentation that are combined to comprise each release of the software. Quality Assurance Quality assurance begins at the requirements stage and runs through the whole gamut of software development. It includes unit and system-wide testing, regression testing, and post deployment validation. Forte has well developed processes, tracking tools, and a team to ensure that the Allegro system is of high quality. Figure 3 illustrates the various teams involved in quality assurance. Fig 3. Quality Assurance Teams at Forte Page 6 of 8 2012, Forte Research Systems, Inc.

Deployment Effort is made to ensure that deployment of a release does not result in down time at an institution. There are no disruptions to workflow when a new version of the software is released. New release deployments generally follow the process below: 1. The deployment of a new release starts with deployment planning. Forte communicates the release plans with institutions. 2. The institution will review the new version and prepare users for its deployment. 3. Forte communicates the scheduled upgrade dates. 4. Forte training team will host webinars to train users at the institution on the new functionality offered in the release. The Whole Product: Training For organizations to derive value from their technology investments, staff members must utilize the technology in their day-to-day operations. Training and ongoing education are essential to ensure that the intended users appreciate the value of the technology, as well as have the required knowledge to appropriately use and benefit from it. With an intuitive interface, the Allegro systems require little training for users to become competent in the functionality and introduce it into their everyday workflows. The minimal need for training has driven the strucuture of Forte s training program. Training Events Below is a list of the typical training events that are offered during the onboarding process. z Initial training Designated training sessions for study coordinators, financial managers, and site administration Training is delivered through a specialized, rolebased Webinar Training involves three hours of guided, hands-on practice in the system Additional sessions are available if needed z Upgrade training z Refresher training (if needed) Training Tools Training tools are tailored to meet the needs of various institutions. The following are some of the training tools that are currently available: z Step-by-step instructions z Training manual z Quick reference guide z Online and on-screen help text The Whole Product: Adoption Initial Implementation Rollout requirements for the Allegro systems are minimal, and research institutions can be up and running within days. This is also accomplished through a fine-tuned implementation plan that addresses most operational nuances and has built-in risk mitigation mechanisms to ensure a smooth implementation. z Assistance loading some large lists of information z Assistance modifying certain settings z Assistance devising a rollout strategy based on previous successes at research institutions The Whole Product: Integration Integration within the institution s local context (be it in-bound or out-bound) would allow institutions to maximize not only the value of their investment in the Allegro software, by virtue of eliminating redundant manual data entry and having more timely availability of data, but also the value of their investments in other technologies, both internal and external systems, that could leverage data captured in the Allegro environment. For these reasons, Forte is receptive to integration with other technologies, currently planning several integration initiatives. One such initiative is to create a web service for interfacing with Allegro. The Whole Product: Community Members of the Allegro user community interact to share ideas, develop best practices, and guide the evolution of Allegro. The foremost goal is to foster clinical research operations excellence. The community is the convergence of different stakeholders including: z The individuals who routinely use Allegro software to perform their day-to-day tasks, such as study coordinators, data managers, and financial coordinators z Others, such as center administrators, and investigators who rely on the information available through the Allegro system, but use the system on a less frequent basis z Forte staff members z The extended Allegro software development community the network of individuals who have an interest in developing and adopting new applications that provide complementary capabilities to the system. To facilitate the interaction between community members, Forte has launched a regular newsletter, which discusses best practices and product updates. Additional initiatives are planned to facilitate community interaction: z Special interest groups z Online community forum 2012, Forte Research Systems, Inc. Page 7 of 8

One of the most valuable outcomes of the Allegro community is the sharing of business operational experiences with different Allegro system functions. This helps those who have yet to adopt that functionality to better plan their software functional rollout in ways that are most beneficial for their institution. Another significant outcome of the participation in the community is the sharing of best practices. By understanding the operational nuances and practices of different institutions, shared best practices can be developed that directly improve clinical research operations. Page 8 of 8 2012, Forte Research Systems, Inc.

Reprints available upon request. Forte Research Systems, Inc. www.forteresearch.com Allegro@ForteResearch.com 608.826.6002 Innovating through Collaboration