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Expediting the Clinical Trial Initiation Process Using the Microsoft Office SystemTechnical Discussion Guide

Expediting the Clinical Trial Initiation Process Using the Microsoft Office System - Technical Discussion Guide 2

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1 Executive Summary..................................................................................................................... 4Purpose of This Guide................................................................................................................. 4

2 Business Challenges and Solutions.............................................................................................6Business Challenges................................................................................................................... 6Addressing the Challenges.........................................................................................................7Clinical Trial Initiation Using the Microsoft Office System............................................................7Benefits....................................................................................................................................... 8

3 Architectural Overview................................................................................................................. 9Solution Architecture................................................................................................................... 9A Sample Clinical Trial Initiation Solution in Action...................................................................10

4 Infrastructure Considerations.....................................................................................................13Software Considerations...........................................................................................................13

Optional Software Considerations.........................................................................................14Scalability Considerations.........................................................................................................15Security Considerations............................................................................................................15

Client Security.......................................................................................................................155 Next Steps................................................................................................................................. 17

Partner Solutions....................................................................................................................... 17Developer Resources................................................................................................................17Solution Showcase for the Microsoft Office System..................................................................18


1 Executive SummaryPharmaceutical companies are under intense pressure to manage costs and protect revenue in the face of growing competition; stringent government regulations; and rising research, development, and marketing costs. Because the duration of patent protection for new drugs is limited, pharmaceutical companies need to move drugs to market rapidly to recuperate up-front investments before competition from generic drug companies erodes the revenue potential. Each day saved during development can translate into significant revenues when the drug reaches the market. To gain FDA approval for a new drug, pharmaceutical companies must pass the investigational compound through vigorous clinical trials, which can account for up to 40 percent of the drug's overall development costs. Streamlining any aspect of the clinical trial process can help speed a drug to market, significantly affecting a company’s profits and potentially improving and saving lives. During the initiation of a clinical trial, the pharmaceutical company must create a protocol that describes the study design. Creation and management of this document are often fraught with challenges, including little or no access to previously created protocol data and time-consuming, paper-based processes for managing documents. A solution that helps streamline the development of the clinical trial protocol document can reduce the time it takes to initiate a clinical trial, thereby reducing the overall clinical trial duration.This guide describes a sample solution that enables communication, collaboration, and protocol document management during the clinical trial initiation process. The sample solution, which is built using the familiar Microsoft® Office System, makes it easy to find and reuse content, facilitate the coordination of document contributors, and manage version control and author access. By providing the technology to support these processes, the sample solution can help pharmaceutical manufacturers expedite the clinical trial initiation process.

Purpose of This GuideThis guide describes the business challenges associated with initiating clinical trials and proposes a solution that can be implemented using the Microsoft Office System. The purpose of this guide is to help pharmaceutical companies understand the benefits of a clinical trial initiation solution based on the Microsoft Office System, evaluate the technology, and assess the integration of such a solution into the company's existing infrastructure. The guide is also of interest to a


company’s IT department as they calculate resources and plan processes to implement and operate such a solution.The sample solution discussed in this guide is based on a reference implementation available for download from Microsoft. For more information on the reference implementation, see Chapter 5, “Next Steps.”This technical discussion guide contains the following information:● A discussion of the business challenges associated with streamlining

the clinical trial initiation process and the benefits of using the Microsoft Office System to build a clinical trial initiation solution

● An architectural overview of a sample clinical trial initiation solution, including a description of the solution in action

● A description of various infrastructure considerations related to a sample clinical trial initiation solution, including software considerations, scalability issues, and security considerations


2 Business Challenges and SolutionsThis chapter highlights several of the challenges that pharmaceutical companies face when initiating a clinical trial. It explains how a solution built using the Microsoft Office System can address these challenges and describes the benefits that an Office-based solution provides.

Business ChallengesPharmaceutical companies need to look for ways to streamline their processes and reduce costs wherever possible. A large portion of the drug development cycle is devoted to clinical trials, where a significant amount of time and resources is spent initiating, conducting, and managing clinical trial studies for investigational compounds. There are number of complexities and inefficiencies in the clinical trial initiation process, ranging from managing collaboration and document development to accessing existing data sources.● Re-creating data – A clinical trial protocol document consists of

scientific data and other information that often can be reused from one clinical study to the next. However, without an efficient way to reuse content, a large amount of time typically is spent searching for and re-creating previously created information and scientific studies.

● Coordinating clinical trials – Clinical trials require the exchange of confidential contracts, sensitive data, and regulated information between pharmaceutical companies and study investigators before, during, and after the trial. Typically, there is no centralized, collaborative environment and too much time is spent coordinating resources and sharing project information among stakeholders.

● Managing protocol documents – At the onset of the clinical trial, the study team lead creates and compiles a protocol document. The processes required to manage, author, assemble, and review the protocol document are often cumbersome, resulting in delays and inaccuracies. Document tracking is also an issue; inaccuracies and noncompliance issues can result when multiple versions of the document from different contributors must be reconciled and untracked versions are circulated in e-mail or created as meeting printouts.

● Accessing data from multiple systems – Data is often managed in multiple systems and data sources, such as clinical trial management systems and investigator databases. In addition, study contributors are


required to work in multiple applications such as Microsoft Office Word, Microsoft Internet Explorer, Microsoft Office Outlook, Microsoft Windows® Explorer, and internal systems such as clinical trial management systems, customer relationship management (CRM) applications, and other systems. Authors waste time determining where information is located and attempting to retrieve information from unfamiliar systems for use in the protocol document.

Addressing the ChallengesTo address the challenges associated with initiating a clinical trial, pharmaceutical companies could benefit from a solution that helps them efficiently create protocol documents and improves collaboration among study team members. Such a clinical trial initiation solution should contain features such as content reuse, a central point for collaboration, document section assignment and protection, and interoperability with other line-of-business systems.● Content reuse – Contributors to a clinical trial protocol document

should be able to search a library of previously approved content that helps them author the new protocol document. The reuse of content helps expedite the authoring process and increases the probability that the content meets the requirements of reviewers. This content should be stored in a central content library that makes it easy to search, preview, and insert text into the document. Contributors should also be able to easily publish new content to the content library.

● Central point for collaboration – Clinical trial team members should be able to collaborate through a centralized location that enables them to share relevant documents, contacts, links, and milestones for effective team collaboration. This location should provide a central point for document creation, review, and approval, and it should be accessible only by authorized users.

● Document section assignment and protection – During the creation of the protocol document, study coordinators should be able to manage document status and ensure accountability by assigning document sections to contributors. By protecting sections of the document, authors can ensure that only designated sections can be edited.

● Interoperability – Contributors to the protocol document should be able to use information that is already captured in a company's other databases or line-of-business systems, such as clinical trial management systems or investigator profile databases. Contributors should have easier methods for inserting the information into the document and updating the information in the line-of-business system.

Clinical Trial Initiation Using the Microsoft Office System

A solution that is built using the Microsoft Office System can address the challenges associated with initiating clinical trials. This guide describes a


sample clinical trial initiation solution that is based on the Microsoft Office System, which enables companies to address their business challenges while taking advantage of existing investments in Microsoft products and providing a familiar working environment.The sample solution described in this guide contains a Word document template that facilitates the creation of protocol documents. The template used in this sample solution combines a familiar Word user interface with a task pane for performing protocol document-specific tasks, such as document section assignment and content library access. From within the Word document, authors and contributors can search a Microsoft Windows SharePoint® Services content library for previously authored relevant content and other information that helps them author the new protocol document. The reuse of content helps expedite the authoring process and increases the probability that the content meets the requirements of reviewers. The sample solution also provides a collaborative Windows SharePoint Services team site that enables authors, contributors, and reviewers to communicate and share documents throughout the clinical trial study. Role-based security ensures that only authorized users can access the documents. Microsoft Office Information Bridge Framework can be used to link to a company's line-of-business systems, such as clinical trial management systems or investigator profile databases, and to make the information from these systems available to authors and contributors from within Word. The Information Bridge Framework-powered task pane in the protocol document enables authors and contributors to search the line-of-business systems for relevant information.The sample solution is described in more detail in Chapter 3, “Architectural Overview."

BenefitsClinical trial initiation solutions can help pharmaceutical companies boost the potential for revenues by streamlining clinical trial initiation processes and speeding time-to-market. A clinical trial initiation solution based on the Microsoft Office System solution offers the following benefits:● Helps clinical study administrators and authors save time and improve

quality by enabling them to reuse previously created and approved content

● Reduces the time and effort required for the study design phase by providing a central location where the project team can find and share information

● Improves protocol quality and avoids the need for rewrites with section assignment, version control, and user access management

● Populates documents more quickly by enabling information retrieval from clinical trial databases and other internal line-of-business systems


Solutions built using the Microsoft Office System can be designed to be scalable and secure and to perform according to enterprise needs. IT departments can quickly implement such solutions because they are easily adapted to business needs. The solutions are easy to learn because they make use of the familiar Office experience. Because companies can use their existing investments in Microsoft products, the solutions are cost-effective. In addition, the solutions are extensible and can interoperate with existing line-of-business systems using XML and Web services.


3 Architectural OverviewThis chapter describes a sample clinical trial initiation solution developed with the Microsoft Office System. It outlines the solution architecture and highlights operations related to protocol document management, collaboration, and interoperability with line-of-business systems.

Solution ArchitectureFigure 3.1 shows the basic architecture of a sample clinical trial initiation solution that runs on Microsoft Windows Server™ 2003 and Microsoft Windows XP. The solution is built using Microsoft SQL Server™, Windows SharePoint Services, Word 2003, and the Information Bridge Framework.

Figure 3.1The conceptual architecture of a sample clinical trial initiation solution

In this solution architecture, the client uses Word 2003 and the Information Bridge Framework to streamline the process of authoring clinical trial protocol documents. The SharePoint team site is accessible through a browser, providing team collaboration and access to document libraries and content libraries.On the server, Windows SharePoint Services hosts the team collaboration sites and provides the library of reusable content and document management features. The Information Bridge Framework client and metadata service provide content library functionality and the ability to easily access information from other systems through the Word task


pane. Web services enable information sharing with external systems and provide communication between the client and the server. SQL Server 2000 databases serve as the primary repository for documents and data.

A Sample Clinical Trial Initiation Solution in ActionThe sample solution uses Windows SharePoint Services to provide a central clinical trial site that can host multiple study-specific protocol sites. You can add members to the team site and give them access based on their roles. When you create a new protocol site, Windows SharePoint Services creates a new protocol document in the document library based on the protocol document template. Figure 3.2 shows the home page of a solution that provides these capabilities.

Figure 3.2An example of a study-specific protocol home page

The sample solution uses Information Bridge Framework task pane technology in Word to support protocol document creation. The protocol document author opens the document on the study-specific protocol site and uses the task pane to assign sections to various section contributors. Notifications are sent from Windows SharePoint Services to the section contributors notifying them that sections have been assigned to them.


Document contributors write new content in the Word document. They use the task pane to search for content in the content library and insert the content into the document. Contributors can also publish new or changed content back into the content library. Figure 3.3 illustrates inserting content from the content library into the protocol document.

Figure 3.3Inserting text from the content library into the protocol document

To insert investigator profile information, section contributors use the task pane to search for a specific investigator in the company's underlying investigator database and insert the investigator's profile information into the document, as shown in Figure 3.4.


Figure 3.4Inserting investigator profile information from a separate investigators database

When finished, contributors save the protocol document to the document library.Upon completion, the document can be accessed by reviewers, who can use the change tracking capabilities in Word to indicate changes and view comments from other reviewers.


4 Infrastructure ConsiderationsThis chapter provides information about the infrastructure considerations that an organization can use to implement a clinical trial initiation solution based on the Microsoft Office System. These topics include examples of Microsoft software products that can be used to build a clinical trial initiation solution and considerations related to the scalability and security of a solution.

Software ConsiderationsThis section lists the Microsoft products and technologies that can be used to create a clinical trial initiation solution using the Microsoft Office System. Table 4.1 lists the software considerations for a deploying a clinical trial initiation solution. Table 4.1 Software ConsiderationsSoftware DescriptionMicrosoft Windows Server 2003

The Windows Server 2003 operating system takes the best of Microsoft Windows 2000 Server technology and makes it easier to deploy, manage, and use. The result is a highly productive infrastructure that helps make your network a strategic asset for your organization. Windows Server 2003 is the required server operating system for Microsoft SharePoint Portal Server 2003. For more information about Windows Server 2003, see:http://www.microsoft.com/windowsserver2003/

Microsoft SQL Server 2000 with Service Pack 3a

SQL Server 2000 provides the enterprise data-management platform your organization needs to adapt quickly in a fast-changing environment. In the sample solution, SQL Server supports Windows SharePoint Services and serves as the primary repository for documents and data. For more information, see:http://www.microsoft.com/sql/

http://go.microsoft.com/fwlink/?linkid=38115



Microsoft Windows SharePoint Services

Windows SharePoint Services enables enterprises to develop an intelligent portal that seamlessly connects users, teams, and knowledge so that people can take advantage of relevant information across business processes to help them work more efficiently. In the sample solution, Windows SharePoint Services hosts the team collaboration sites and provides the library of reusable content and document management features. For more information, see:http://www.microsoft.com/windowsserver2003/technologies/sharepoint/default.mspx

Microsoft Office 2003 including Microsoft Office FrontPage® 2003 and Microsoft Office InfoPath 2003

Office 2003 Editions can help organizations and their employees transform information into impact. Support for XML and Web services within the Microsoft Office System applications enables organizations to connect their desktop programs to line-of-business systems in an intuitive, cost-effective way. In the sample solution, Microsoft Word supports protocol document creation and provides a task pane that enables content reuse, connection to line-of-business systems, and other document actions.For more information, see: http://www.microsoft.com/office/editions/prodinfo/default.mspx

Microsoft Office Information Bridge Framework

The Information Bridge Framework is a set of tools and technologies that use the support for XML and Web services within Microsoft Office System applications to extend the Microsoft Office System, enabling information workers to view and act on business data from within the familiar Microsoft Office System programs. In the sample solution, the Information Bridge Framework provides content library functionality and the ability to easily access information from other systems through the Word task pane.For more information, see:http://msdn.microsoft.com/office/understanding/ibframework/default.aspx

Optional Software ConsiderationsThe sample clinical trial initiation solution described in this guide uses the Information Bridge Framework to provide the task pane functionality in the Word protocol document. However, you can use other technologies to manage the communication between the client and the Web services, allowing the client to access the data necessary to create and manage protocol documents.








For example, Microsoft Visual Studio® Tools for the Microsoft Office System allow developers to use Visual Studio .NET and the Microsoft .NET Framework to create business solutions built on Word. More information about Visual Studio Tools for the Microsoft Office System is available at:http://msdn.microsoft.com/vstudio/office/officetools.aspx

Scalability Considerations By using Microsoft Office System products that are easy to configure and customize, pharmaceutical companies can overcome the constraints of existing systems. You can implement a clinical trial initiation solution built using the Microsoft Office System on one server, two servers, or on a server farm based on your organization’s size and requirements. For example, a company hosting only a few sites could run Windows SharePoint Services on a single server, using the same content database for all sites. Windows SharePoint Services uses a distributed server architecture to enhance performance and scalability. Servers can be clustered for high availability and load balancing. This architecture helps you deploy server farms that achieve high levels of performance and reliability. To keep up with growing demand, you can add servers to the server farm as your requirements increase.

Security ConsiderationsThe information in this section is designed to provide a starting point for exploring the security-related considerations in the clinical trial initiation solution you create using Microsoft Office System within your environment. Microsoft partners are available to assist with considering the security of your solution. The following resources provide general security information for Microsoft products and technologies.● Microsoft TechNet Security Resource Center. TechNet provides

security resources at the Security Resource Center. Check this site regularly for the latest security headlines and for information about updates at:http://www.microsoft.com/technet/Security/default.mspx

● General Security Guidance. Microsoft offers a wide variety of security guidance for IT professionals and developers at the Security Guidance Center at:http://www.microsoft.com/security/guidance/default.mspx

Client SecuritySharePoint Products and Technologies provides a security layer for defining and managing user permissions. Permissions can be configured per site to use unique permissions or permissions can be inherited from a top-level site. You can also adopt a role-based approach for configuring permissions. For configuring role-based permissions, you can use the

http://go.microsoft.com/fwlink/?LinkId=37336




Windows SharePoint Services group membership system, in which each user is associated with a set of permissions. This set of permissions identifies what actions the user can perform. You can use the Windows SharePoint Services groups to control which users can perform specific actions on the Web site. To understand how SharePoint Products and Technologies uses the elements that interact with and affect your security for Web site content, see "Security Architecture for SharePoint Products and Technologies" at:http://www.microsoft.com/technet/prodtechnol/sppt/reskit/c0661881x.mspx




5 Next StepsThis chapter reviews steps that you can take if you decide to implement a clinical trial initiation solution using the Microsoft Office System. The chapter provides information about partners that can help you develop a clinical trial initiation solution. It also provides information about resources for developers that can help guide your planning.

Partner SolutionsMicrosoft industry partners play an important role in developing a solution for clinical trial initiation. A partner can provide subject matter expertise and deployment support, customize a solution by adding custom Web services and other tools, enhance the workflow and security of a solution, and assist in understanding and automating important business processes that are currently manual. You can find more information about partner solutions at:http://www.microsoft.com/office/showcase/cti/partnersol.mspx

Developer ResourcesThe sample solution mentioned in this guide provides one approach you can take to developing a clinical trial initiation solution in a pharmaceutical company. This sample solution is based on a reference implementation available for download from Microsoft. This reference implementation contains sample code, templates, and guidance that demonstrate the possibilities in using the Microsoft Office System to address critical business issues. More information about the Clinical Trial Initiation Reference Implementation is available at:http://www.microsoft.com/downloads/details.aspx?FamilyId=39BA722D-551F-4399-BC5D-CA6F43599AFF&displaylang=enFor information about some of the products mentioned in this guide, see the following Web sites: ● Information Bridge Framework

http://msdn.microsoft.com/library/default.asp?url=/library/en-us/odc_ibf2003_ta/html/odc_ibfintro.asp

● Microsoft Office Developer Centerhttp://www.msdn.microsoft.com/office/

● Microsoft SharePoint Products and Technologies Software Development Kit (SDK)








http://www.microsoft.com/downloads/details.aspx?familyid=AA3E7FE5-DAEE-4D10-980F-789B827967B0&displaylang=en

Solution Showcase for the Microsoft Office SystemThe Solution Showcase for the Microsoft Office System highlights how leading organizations solve business problems using the Microsoft Office System. The Solution Showcase provides information about how Microsoft customers can obtain more value from their investments in the Microsoft Office System.For more information about the Solution Showcase, see:http://www.microsoft.com/office/showcase





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