White Paper | January 5, 2010Written by Robert Webber, CEO, TranSenda International

Five Things Clinical Trial ProfessionalsShould Know About SharePoint

TranSenda is now a part of

The Five Things

1. SharePoint is rapidly becoming the de facto stan-dard collaboration platform across industries.

2. It’s not just about documents – it’s about informa-tion.

3. SharePoint lists give you the power to manage clini-cal operational information.

4. SharePoint allows you to still use your favorite Microsoft Office desktop applications.

5. SharePoint is secure, scalable and can meet your regulatory requirements.

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SharePoint – A New World of Information Management and Collaboration

SharePoint has been adopted by over 17,000 companies, and it has become Microsoft’s fastest growing product ever. There is good reason for this exponen-tial growth – more and more people across diverse industries are finding that it improves their productivity and takes the knowledge worker to a new level of real-time insight to more effectively manage business processes. Life Sciences companies are eager to benefit from SharePoint capabilities, but not quite sure how its capabilities can be leveraged in the highly regulated world of clinical trial management.

Let’s start with the description of SharePoint Server directly from the Microsoft SharePoint overview on Microsoft’s web-site.

Microsoft Office SharePoint Server 2007 is an integrated suite of server capabilities that can help improve organizational effectiveness by providing comprehensive content management and enterprise search, accelerating shared business processes, and facilitating information-sharing across boundaries for better enterprise within one integrated platform, instead of relying on separate fragmented systems. Additionally, this collaboration and content management server provides IT professionals and developers with the platform and tools they need for server administration, application extensibility, and interoperability.

What this means is that SharePoint is a server application that works behind the scenes to allow you to work with information on your PC. You are likely familiar with Microsoft Exchange Server that sits behind your desktop Outlook applica-tion – it centralizes email information from the Internet and from within the orga-nization so that you can view and respond to emails. And, your email can also be brought up in your desktop browser. In a similar way, SharePoint serves as the central application that consolidates data from within your organization, and supports your desktop applications—including your browser—to translate that data into information.

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Here’s an example of a simple portal viewed through your browser that can be configured quickly out of the box with a few clicks, using one of the many stan-dard portal templates available.

Note that in the above example, the calendar and announcement sections of the portal are known as SharePoint “Web Parts”. Just think of them as little boxes of information that can be added to a portal in any combination to give you the information that you want to see in a web page through your browser. Web Parts can just report information, or they can also allow you to input data, as in the case of the announcement Web Part.

As Microsoft indicates in their SharePoint description, SharePoint itself is an open development platform that allows developers to build their own Web Parts. In fact, there are companies that offer low-cost Web Parts that can help trans-late data into information the way you would like to see it on your portals. One example is Bamboo Solutions. You may want to browse their Web Part store to see examples of how the SharePoint platform can be enhanced to offer a won-derful array of choices in how your information is presented. It truly is a new world of vastly improved information management using lower cost software.

SharePoint provides a new level of visibility into information to help today’s knowledge worker more effectively manage their tasks and processes, increas-ing productivity while at the same time removing the limitations and frustrations of inaccessible information.

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More than Document Management

People who are only vaguely familiar with SharePoint often believe it is just a document management repository. SharePoint does provide a strong document management component with the standard check-in and check-out features one would expect, but its features and functions go well beyond document manage-ment. Centralizing data is only one piece. Microsoft recognized that it is what you can do with centralized data that can really impact how today’s knowledge worker performs their day to day tasks. Today, we are inundated with data – the challenge is to turn it in to useful and highly focused information that aligns with how people work, and not the other way around. At the highest level, think of SharePoint as a platform that works behind the scenes to deliver just the infor-mation you need when you need it through the Microsoft Office applications that you use every day.

Here’s how Microsoft depicts the components of SharePoint. Click on the links to get more specific information.

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CollaborationAllow teams to work together effec-tively, collaborate on and publish documents, maintain task lists, implement workflows, and share information through the use of wikis and blogs.

PortalsCreate a personal MySite portal to share information with others and personalize the user experience and

content of an enterprise Web site based on the user’s profile.Enterprise Search

Quickly and easily find people, expertise, and content in business applications

Enterprise Content ManagementCreate and manage documents, records, and Web content.

Business Process and FormsCreate workflows and electronic forms to automate and streamline your business processes.

Business Intelligence Allow information workers to easily access critical business informa-tion, analyze and view data, and publish reports to make better-informed decisions.

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SharePoint Lists andClinical Trial Management

This is one of SharePoint’s less understood and most powerful capabilities, especially when it comes to clinical trial management. Just being able to access the right versions of documents alone is a huge leap forward from the disorga-nized and multiple versions that typically exist within an organization. However, documents organize information in what is called “unstructured data”. All the information is there, but it doesn’t exist within tabular structures that facilitate sorting, filtering and the ability to analyze information using relationships among data. That’s why we use both Microsoft Word and Excel. Microsoft Office allows us to work within both worlds – unstructured data through Word and structured data through Excel. There is still a need to organize information in terms of rows and columns.

Now, to be complete, I should mention that there is a lot of great work going on to allow us to use unstructured data more effectively. You may have heard of XML, or Extensible Markup Language. Documents, and even web-site pages, contain a hidden set of tags within the text to make it easier for computers to locate specific pieces of data. And, Microsoft Word supports XML interchange. But, it does not replace the need to work with structured data so our beloved spreadsheets will be around for some time.

But, there are issues with spreadsheets in clinical trial management. Most of us have experienced the frustration of trying to collaborate with people who are frantically searching for the right spreadsheet version that was sent around by email. And, where did the data come from? This is certainly not conducive to the disciplined data management practices required of a clinical trial. So, Clinical Trial Management Systems (CTMS) appeared on the scene to replace spread-sheets with fixed input and reporting through hard coded user interfaces. How-ever, spreadsheets created from exports from these systems still propagate. I even heard one clinical IT group at a recent CTMS conference refer to them-selves as the “spreadsheet police”, continually on-guard to prevent people using spreadsheets instead of their internal CTMS. It begs the question as to why users still feel they need to use their spreadsheets, and why the IT group feels that they need to stomp them out.

From the user perspective, they want to use whatever means necessary to fill their need for information. Unfortunately, no hard coded Clinical Trial Manage-ment System can anticipate the information needs for every user, especially considering the diversity of clinical studies. From an IT perspective, and also from that of regulatory affairs, spreadsheets represent a regulatory compliance nightmare due to multiple versions with no record of data sources. But, is it fair to take away a tool that can significantly help the clinical trial professional get the job done? Is there a win-win solution here? The answer lies in a very power-ful SharePoint capability – SharePoint lists.

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Just as SharePoint supports document libraries that can be selected and viewed from your browser, SharePoint supports navigation to both document libraries and something called a SharePoint list. Here’s an example of a Share-Point list:

It simply is a list with a set of named columns, and rows of data within the col-umns. You might be thinking that this looks similar to a spreadsheet, and you’re right. In fact, SharePoint makes it possible to view the data as a spreadsheet. With a single click your SharePoint list now looks just like a spreadsheet. In fact, it even allows you to edit the data within each cell, and save it back to the SharePoint list.

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But, it can go one step beyond. With just a few clicks, you can create a personal spreadsheet that is automatically populated with the rows and columns from the SharePoint list, and then save it locally. Every time you open the spreadsheet, it will be updated with the latest values from the list. You get to analyze the data in any way you want, while ensuring that you are using accurate and up-to-date source data. Here’s an example of a spreadsheet chart that uses a SharePoint clinical operational data list from TranSenda’s Office-Smart Clinical Trial Man-ager.

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SharePoint can even work in conjunction with Microsoft’s Excel Services to allow such charts and tables to be published in SharePoint portals, like the example below.

To complete the picture, we should discuss how the data gets into the Share-Point lists. If it were just input with free-format spreadsheets, or entered directly into the list, it would not necessarily adhere to the business rules of the clinical study. This is the other side of SharePoint. It provides tools to take data from back-end software applications or databases. For example, the data may actu-ally exist within your company’s CTMS or EDC systems. SharePoint web-ser-vices and a feature called Business Data Catalog support integration with back-end or remote systems to make it available and accessible in one place. To meet the needs of clinical trial professionals, TranSenda uses a unique patent-pending approach that structures the external data into clinical operational data lists, the same SharePoint lists we discussed above, and then maintains syn-chronization with its Office-Smart Clinical Trial Manager, precluding the expense and time of an internal SharePoint integration project. SharePoint lists are automatically created that are aligned with TranSenda’s ClinBUS® opera-tional data format.

Regardless of how the data is fed into the SharePoint lists, the resulting lists provide a controlled “single version of the truth” in real-time that is now open to the world of Microsoft Office desktop applications, not just Excel, as we will see in the next section.

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Microsoft Office Interoperability

We focused a lot on Excel, because this is a common personal productivity tool used by the clinical trial professional. But, SharePoint allows you to leverage other Microsoft desktop applications – using the regulatory compliant data from your back-end clinical trial systems.

MICROSOFT OUTLOOK Here’s an example of how the SharePoint lists can be accessed directly from your familiar daily Outlook view.

MICROSOFT ACCESS TranSenda’s Office-Smart Clinical Trial Manager preserves the relationships between the SharePoint lists to enable personal report generation using a sim-ple report wizard. A report like this can be configured in just a few minutes by dragging the desired columns into the report.

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MICROSOFT INFOPATH Easy-to-build forms can be populated directly from SharePoint lists.

These are just some examples of how SharePoint allows you to use the Micro-soft personal productivity desktop tools the way they were intended – based on data from fully-compliant back-end clinical systems.

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Security, Scalability andClinical Trial Regulatory Requirements

SharePoint data security and the ability to meet the needs of even the largest pharmas has been demonstrated through numerous successful validated SharePoint deployments in life sciences companies. And, SharePoint is in use in industries with substantially higher transaction rates with data integrity requirements equivalent to those of clinical trials, like the financial and banking industries. TranSenda’s customers today are using SharePoint in conjunction with Office-Smart Clinical Trial Manager and Office-Smart Clinical Payment Manager to get the best of both worlds – the security and deep functionality of back-end clinical systems while being empowered to use their familiar Microsoft Office desktop productivity tools – what TranSenda calls the Office-Smart world of clinical trials.

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