Purdue Pharma
"The iBox and SharePoint Portal Server solution makes our drug development model—and our business—practical. How do you measure the return on investment of that?" -Anthony Sclafani, Assistant Director, Collaborative Business Solutions, Purdue Pharma.
Purdue Pharma needed a better way to manage clinical trial documentation, especially after it adopted a business model in which third-party organizations conducted those trials and sent the documents to Purdue staff. The company's solution was to build a document management solution based on Microsoft® Office SharePoint® Portal Server 2003 (an upgrade to Office SharePoint Server 2007 is planned for the end of this year) and the iBox metadata management and search solution from Interse, a Microsoft Gold Certified Partner. Thanks to the solution, many of the processes associated with document management have been automated and enhanced. The company now automatically associates up to 38 industry-specific metadata tags with each document, enabling more relevant searches as well as helping users to search across documents in new ways, for new insights and better decision making.
Situation
Purdue Pharma, a pharmaceutical company, is known for its research on chronic pain management. Like the other companies in its industry, Purdue is subject to rigorous clinical trial requirements as part of the years-long process of preparing new products for U.S. government approval and commercial availability. To meet those requirements, Purdue oversees several clinical trials for each product under development—and produces up to hundreds of thousands of pages of documentation per trial.
Storing, finding, and using this amount of documentation wasn't easy. The company maintained the information in a multitude of shared folders in the Windows® operating system and a Documentum repository. It took a long time to find information, and search results couldn't include all of the company's information stores, so users spent a lot of time and effort locating needed files.
The company could associate only minimal metadata with files—just the document creator and date, but nothing specific to the company's clinical trials, such as the clinical program, study, investigators, active ingredients, or dosage strength. And that metadata had to be tagged by hand, opening the door to inaccuracy and omission.
That lack of extensive, specific metadata only added to the difficulty in locating infor-mation. What's more, files were exchanged as e-mail attachments, and their file names could be changed by recipients, which made it difficult to know which version of a file was most current.
"A person could spend days trying to find a document," says Anthony Sclafani, Assistant Director, Collaborative Business Solutions at Purdue. "Going through file shares was a completely manual process. This was a problem with very practical implications because delays in locating files could add to the multimillion-dollar costs of product development. And when federal regulators requested files as part of their review of our clinical trials, we were required to produce that material under strict deadlines."
The difficulties with managing files and searching for clinical trial data were exacerbated when Purdue took on a new business model in which all clinical trials were conducted for the company by outside clinical research organizations (CROs) and managed by the pharmaceutical company's in-house staff. CROs used secure e-mail or File Transfer Protocol to send files to their contacts within the company.
But because multiple departments within Purdue were responsible for receiving the files, saving them to the document repository, and transferring them as needed throughout the company, the problem of having multiple versions of files only increased. Hunting for the right documents could be a labor-intensive and inefficient process.
When the company began to prepare for its first series of clinical trials under its new business model, executives agreed that they needed a new way to receive, manage, and work with documents from its CROs. Any new process the company adopted had to improve the efficiency of receiving and managing the documents for Purdue staff. Finding specific documents needed to be far easier than it was with the present system.
That meant the solution needed to allow for an extensive metadata schema, one that would enable users to conduct highly refined searches and deliver the most relevant search results—particularly when a request for information came with a deadline from the U.S. Food and Drug Administration.
"We had no easy way to provide third-party CROs outside of our IT network with access to our legacy document repository," says Sclafani. "The metadata tags in our old system didn't match the type of information we wanted to gather. It would have been extremely expensive and time-consuming to modify them, and our licensing costs would have gone up."
Solution
Instead, Purdue based its document management and search solution on a technology it was already using: Microsoft® Office SharePoint® Portal Server 2003. The company had relied on SharePoint Portal Server for three years for its intranet. Now, it moved its clinical trial document library from the shared folders to the software. The company has deployed a test environment for Microsoft Office SharePoint Server 2007 and plans to move the document library to it by the end of this year.
"We were familiar with SharePoint Portal Server," says Sclafani. "We knew that it worked. We had an Enterprise Client Access License agreement from Microsoft, so we knew we could deploy the technology easily and cost-effectively."
To meet its extensive needs for metadata management, Purdue augmented SharePoint Portal Server with the iBox metadata management solution from Interse A/S, a Microsoft Gold Certified Partner. The iBox solution integrates fully with SharePoint Portal Server and provides both metadata management and search capabilities across the company's entire document management environment, including the legacy document repository, which Purdue still maintains for regulatory compliance reasons.
One of the first, and most extensive, steps in planning the deployment was creating a template in SharePoint Portal Server for the clinical project and clinical trial sites. The template defines the subsites and files that would reside on a typical clinical project site and the relationships among them, including "public" subsites accessible to the CROs and "private" subsites accessible only by Purdue personnel.
The company then used iBox to create a metadata template for the files that would be housed on the SharePoint sites. Each time a business user creates a new clinical project site using the site template, imported files then inherit the relevant metadata fields. For example, files in a protocol folder inherit the protocol metadata template, whereas files in a clinical study folder inherit that metadata type.
The iBox solution then automatically prepopulates the vast majority of the metadata fields associated with the file. Each of the Purdue files has up to 38 metadata fields, all but two of which—the status of the document and its date of approval—are prepopulated automatically by iBox.
Personnel at the CROs upload the clinical trial documents using a Web browser interface, which relieves Purdue of the need to deploy and maintain client software at its various CROs. The documents are automatically tagged and indexed by iBox and stored in the SharePoint site. When Purdue personnel wish to find documents, they use an iBox Web Part integrated into SharePoint Portal Server. This search interface accesses the iBox engine to develop and return search results. In addition to conducting full-text searches, users can search on any combination of the metadata associated with the Purdue files.
The combined iBox and SharePoint Portal Server solution is hosted on a pair of load-balanced HP ProLiant DL380 computers running the Windows Server® 2003
Benefits
Purdue is implementing this document management solution as a part of an ongoing effort to enhance its clinical development process. The company expects to gain significant new efficiencies.
Makes the Business Model Possible
"The iBox and SharePoint Portal Server solution makes our drug development model—and our business—more efficient," says Sclafani. "How do you measure the return on investment of that?"
Sclafani points to the variety of ways in which the solution streamlines current business processes or enables new ones:
- With the iBox and SharePoint Portal Server solution, the work of uploading the documents to the document library is managed by the clinical research organizations.
- Because metadata creation is almost entirely automated by iBox, Purdue's staff does not have to spend time creating the in-depth metadata needed for highly effec-tive searches. And because the automated process is highly accurate, Purdue staff members spend less time reviewing and correcting the errors that might otherwise occur with manual entry of metadata.
- Creating a new clinical project document site used to take up to half a day. Since Purdue has deployed the new solution—with its templates in SharePoint Portal Server and inheritable metadata from iBox—that process has been cut to minutes.
- Notifications at the folder level enable Purdue personnel to know when documents have been added to the SharePoint document libraries, without having to continually visit the sites.
- Before the solution was in place, clinical studies could not be concluded until the staff went through a time-consuming process of tracking down all required documentation. The new solution enables Purdue to track the status of documenta¬tion throughout the clinical study process so that, by the time a study is completed, virtually all required documentation is in the SharePoint site. This capability can shave weeks and even months off the time needed to close a study.
Enables More Relevant Searches for Better Decision Making
Perhaps most important are the new ways in which the Purdue staff can work more effectively with clinical data, thanks to the more detailed and, hence, more relevant searches enabled by iBox and SharePoint Portal Server.
"We can do things we simply couldn't do be-fore," says Charles Willmer, Purdue's Senior Director of Clinical Systems. "We can access and review information in ways that were too time-consuming to contemplate without this solution. For example, if we want to see all the statistical analysis plans written for a cer-tain kind of drug, or to compare the statistical analyses conducted for different drugs, we can pull up exactly that information in a single search. We get the information with a few clicks, instead of the enormous human effort that would have been required before."
The ability to conduct more sophisticated searches more quickly means that the Purdue staff has more information with which to make better decisions about the conduct of clinical trials. And better decisions can potentially shorten the length and reduce the cost of the product development process.
Reduces Deployment Costs
Because the company depends on the new solution to accept, tag, store, find, and use clinical trial documents, Purdue was willing to make a significant investment to deploy it. But with iBox and SharePoint Portal Server, the company didn't have to. Purdue acquired Office SharePoint Portal Server through its Enterprise Client Access License, and it found iBox licensing to be very cost-effective, as well. In addition, deploying the solution was an inexpensive process: The company's in-house staff designed and deployed the solution in a matter of weeks.
"Retooling our legacy document management solution would have cost some multiples of what we spent on the iBox and SharePoint Portal Server solution," says Sclafani. "And it would have taken far longer to deploy."
Microsoft Office System
The Microsoft Office system is the business world's chosen environment for information work, providing the programs, servers, and services that help you succeed by transforming information into impact.
For more information about the Microsoft Office system, go to: www.microsoft.com/office
About Interse A/S
Interse A/S is a software company focusing on bringing productivity and speed to information workers in leading knowledge-intensive companies. Interse A/S is a Microsoft Gold certified partner.
Overview
Country or Region: United States
Industry: Pharmaceuticals
Customer Profile
Purdue Pharma L.P. is a privately held pharmaceutical company known for its research on chronic pain management. Headquartered in Stamford, Connecticut, it has approximately 1,200 employees.
Business Situation
Purdue decided to outsource its clinical trials and needed new business processes to manage the resulting documentation.
Solution
The company adopted an integrated metadata management and search solution based on Microsoft® Office SharePoint® Portal Server 2003 and iBox search from Interse A/S, a Microsoft Gold Certified Partner.
Benefits
- Makes a new business model possible
- Enables more relevant searches for better decision making
- Lowers deployment costs
To view the full case study click here: 
 |