Windows PhoneCustomer Solution Case Study

Clinical Trial Solution Provider Improves Competitive Edge with New Mobility Solution

OverviewCountry or Region: United StatesIndustry: Life sciences

Customer ProfileHeadquartered in Pittsburgh, Pennsylvania, invivodata provides clinical trial solutions using mobile technology to collect patient data for customers around the world. The solution provider employs more than 100 people.

Business SituationWhen its hardware provider transitioned to another market, invivodata needed to find the right platform to build the latest release of its mobile electronic patient diary solution.

SolutionThe next iteration of the invivodata e-diary was deployed on the HP iPAQ 210 Enterprise Handheld running the Windows Mobile operating system.

Benefits Provides reliable data to build

competitive edge Increases customer return on

investment Increases business agility for better

customer service

“With Windows Mobile and the HP device, we can drive the fundamental value proposition for electronic patient-reported outcomes—improving compliance to generate reliable data—and that’s good for business.”

Doug Engfer, Cofounder and Chief Executive Officer, invivodata

Beginning work in 1987, invivodata founders pioneered the use of mobile technology to help patients report valid, reliable, accurate clinical data during pharmaceutical trials. The company used the Palm Pilot handheld device as the platform for its electronic patient-reported outcomes (ePRO) solution, but it needed a new platform when Palm transitioned to the mobile phone market. Impressed with the Microsoft commitment to its products, invivodata redesigned its ePRO solution to run on the Windows Mobile operating system on the HP iPAQ device. The solution provider found a rich development environment in Windows Mobile that works with IT tools already in use. In addition, patients get a user-friendly experience that drives compliance with study protocols to generate reliable data—a key competitive advantage that invivodata expects will help it win, and keep, more customers.

SituationOver the past two decades, invivodata has pioneered the use of mobile technology for collecting patient data during clinical drug and medical device trials. With a market-proven combination of scientific, technological, and regulatory expertise, invivodata has helped orchestrate the evolution of the electronic patient-reported outcomes (ePRO) industry and continues to provide innovative methods that make it easy for customers—ranging from global pharmaceuticals to small biotech start-ups—to attain accurate and reliable clinical trial data.

Shaping the ePRO IndustryIn the clinical research world, patient-reported outcomes (PRO) data is considered accurate only if the patient adheres to the specific protocols designed for each trial. “Previously, patients were given paper diaries and asked to complete questions at specific times,” says Doug Engfer, Cofounder and Chief Executive Officer (CEO) at invivodata. “However, when my cofounder Dr. Saul Shiffman was researching nicotine addiction back in the 1980s, he discovered just how flawed that paper-based process was. Patients left to fill out paper questionnaires simply didn’t complete them when and where they were supposed to.”

As a result, trial sponsors had diminished confidence in their study data, trial sample sizes had to be larger, research was more expensive, and potentially life-saving drugs took longer to get to market. “We saw this as an opportunity to use technology in the service of science, and decided to introduce a new paradigm for PRO,” says Engfer.

So invivodata scientists developed a new methodology for collecting patient data using mobile technology. Over the years, the company established itself as a leader in the ePRO industry, gaining a reputation for generating scientifically valid data from patients in clinical trial research.

“Our whole existence has centered on mobility-based products, and our approach has always been based on collecting information from patients in their natural settings, in real time,” says Engfer. “We consult with customers to develop research questions that map to the marketing and labeling claims that the company is aiming for, while incorporating best practices related to ePRO regulatory and behavioral science guidelines. Then we configure [mobile] devices with our ePRO system, a proprietary reusable core application that we use for all clients, and we apply the trial-specific modifications that result in a software solution specific to each trial’s protocol.”

Patients readily integrate small, convenient, user-friendly devices into their lives and willingly use them to enter data according to protocol requirements, invivodata has found. Patients use the devices to answer research questions and upload the data wirelessly to the invivodata study database. From there, invivodata delivers the PRO data to customers for analysis that yields the insights needed to determine whether they can bring their products to market.

Looking for a New E-Diary PlatformUntil recently, invivodata used the Palm Pilot to run its DiaryPRO® electronic patient diary. However, as Palm transitioned to the smartphone market, invivodata took the

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“Our whole existence has centered on mobility-based products, and our approach has always been based on collecting information from patients in their natural settings, in real time.”

Doug Engfer, Cofounder and Chief Executive Officer, invivodata

opportunity to evaluate other hardware and software providers for a new e-diary platform. The company had a firm list of requirements for its handheld devices. They had to offer a tap-and-touch–based, graphical user interface to guide patients quickly through the trial protocol and simplify data entry. They had to be small enough to put in a pocket or purse and be capable of generating sounds to remind patients to answer questions and enter data at the right times.

Equally stringent requirements existed for the software that invivodata needed to build a new version of its ePRO system. The software had to offer developers a flexible, powerful development environment to promote agility when configuring trial studies for customers. Developers had to be able to perform trial-specific modifications to map to customers’ protocols without having to develop trial-specific software from scratch each time. The software also has to localize easily for deployment in trials around the world.

So invivodata began looking for a replacement platform that would continue to improve the company’s competitive edge in the ePRO industry. “Our customers care about the quality and durability of our solution,” says Engfer. “So for us to be able to provide that long-term reliability, we need to find software and hardware partners that will offer us the same commitment to their products.”

SolutionThe next iteration of the invivodata e-diary was deployed on the HP iPAQ 210 Enterprise Handheld running the Windows Mobile operating system. The device

features a four-inch touch screen and integrated IEEE 802.11b/g and Bluetooth 2.0 technology that allows patients to upload their data using a wireless connection.

“Our decision to go with Microsoft is all about trust,” says Engfer. “We don’t sell brand-specific functionality; we sell confidence in our solution. Microsoft is a trusted name, and our customers rely on invivodata to be a trusted partner. Microsoft is committed to the Windows Mobile platform, and the standards that it has established give our customers confidence in our ability to support them for the long term.”

Because invivodata wanted a device for a single use, it chose the HP iPAQ running Windows Mobile, instead of the Apple iPhone. “We configure the device with our software and that’s all it does—no phone, no calendar, no e-mail,” explains Jon McClelland, Vice President of Product Development at invivodata. “The Windows Mobile operating system allowed us to build and run a single-purpose enterprise application, where the iPhone isn’t set up that way.”

The company also liked the synergy between the Windows Mobile development environment and other applications and tools that invivodata developers had already created, including a Windows-based version of the core application that runs on the Tablet PC and internal productivity tools. In addition, the company reasoned that a new version of its core application would have to work with the tools that developers already used to configure the application to meet the

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“The Windows Mobile operating system allowed us to build and run a single-purpose enterprise application, where the iPhone isn’t set up that way.”Jon McClelland, Vice President of Product

Development, invivodata

specifics of each study protocol, such as alarm sequences or logic built into the questionnaires.

“The development tools that we build internally to create these study configurations are all Windows based,” says McClelland. “We wanted the new handheld device to share the same code as the version of our product that runs on the Tablet PC. The more we can share code between these devices and our development tools, the easier it is for our developers to work equally productively among all our applications and products.”Building the ApplicationThe developers built the new e-diary application using Microsoft Visual Studio 2005 Team Edition for Software Developers and the Microsoft .NET Compact Framework, a development framework that enables developers to work with managed code and Web services on resource-constrained handheld devices such as the HP iPAQ.

“The Visual Studio 2005 tools have a very strong connection to the third-party device emulator that allowed us to run simulations of our code as if it’s running on the device but is in fact connected directly to the compiler and debugger,” says McClelland. “This was very helpful in analyzing software performance.”

The company worked with Microsoft and HP to help configure the devices for a single-use environment. “Microsoft provided excellent feedback to allow us to create this single-use device with security features capable of dealing with confidential patient data,” says Tom Henson, Vice President of Marketing at

invivodata. “We have to ensure that no one can pick up the device and see patient information or alter the data that has already been entered into the system, due to regulatory requirements for collecting patient clinical data.”

The Windows Mobile operating system offers security-enhancing features such as CryptoAPI, which uses an encryption key to encrypt data so it can be transmitted on a nonsecure network without compromising the security of patient information. To decrypt the data, the corresponding decryption key must be used.

“As the patient enters the data, it is encrypted and stored in the local database. So it’s not capable of being viewed or altered, and it remains in that encrypted state through the transmission back to our central server,” explains McClelland. “The device connects wirelessly and securely to a data transfer router, which transfers the data using a wired or wireless connection. We also set security policies on the Windows Mobile devices by limiting the functionality that’s exposed to a patient so that he or she can’t shut down the application.”

Going to MarketIn May 2009, invivodata launched an extensive field test program to ensure reliability and stability in many different usage scenarios, with patients ranging from children to octogenarians who have never used a computer. The company also had to ensure that the devices would connect to its database and transfer data securely from all over the world.

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“Microsoft provided excellent feedback to allow us to create this single-use device with security features capable of dealing with confidential patient data."

Tom Henson, Vice President of Marketing, invivodata

In October 2009, invivodata launched the latest version of its e-diary application running on Windows Mobile to its first customer, a global pharmaceutical company. Today, the company is using the solution to run trials in more than a dozen sites in multiple countries. Over the course of 2010, invivodata expects to transition 100 percent of its new deployments to the Windows Mobile–based solution. The company anticipates launching an increased number of electronic patient-reported outcomes studies, compared with the prior year.

BenefitsUsing the rich development environment of Windows Mobile, invivodata can continue to innovate with new e-diary features and functionality, solidifying its position as a leader in capturing clinical patient data of the highest integrity for its customers. With the combination of the HP iPAQ device and Windows Mobile, invivodata is building its competitive edge by offering the long-term reliability that its customers need for trials that can last up to three years. The company also is increasing return on investment (ROI) for its customers, and driving business agility to provide better customer service.

Provides Reliable Data to Build Competitive EdgeA key value proposition that invivodata offers its customers is long-term reliability. CEO Engfer believes that working with Microsoft and developing the latest e-diary software on the Windows Mobile operating system will generate a long-term competitive advantage for the company.

“We have to be consistently reliable, and the new platform has definitely enabled us to do that,” says Engfer. “We can provide a consistent patient experience so that the data our customers collect is comparable from study to study and from program to program. That’s because both Microsoft and HP are committed to their respective pieces of the puzzle—Microsoft to Windows Mobile and HP to its devices. The result is a solution that we can deploy in the field for many years. That’s a key value driver for our customers because it’s important that all the patients use the same equipment over the course of the trial, and that results be comparable between trials.”

Increases Customer ROI to Drive SalesThe solution provider expects the new platform for the e-diary application to increase the return on investment for its customers. Compliance with protocol is critical in the patient-reported outcomes industry. The more closely the patient follows protocol, the more reliable and useful the data. With an approachable user interface and a reliable upload mechanism to get the data on a regular basis, the Windows Mobile version of the invivodata e-diary application is expected to drive business.

“With Windows Mobile and the HP device, we can drive the fundamental value proposition for electronic patient-reported outcomes—improving compliance to generate reliable data—and that’s good for business,” says Engfer. “When our customers have reliable data to work with, they can save money by reducing trial size and duration, and they can increase their ROI by bringing drugs to market more quickly. Naturally, they are going to turn to

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“Windows Mobile has accelerated our ability to develop more enhanced internal tools to manage and configure our devices.”Jon McClelland, Vice President of Product

Development, invivodata

the company that gives them that advantage.”

Increases Business Agility for Better Customer ServiceAnother selling point for invivodata is the ability to quickly validate the ePRO system and configure the devices for specific trials—for example, programming them with predefined alerts that remind patients to enter data according a customer’s specific protocol requirements.

“Our ability to get the software onto the platform quickly and efficiently is a key differentiator in the customer service that we provide,” says McClelland. “Windows Mobile has accelerated our ability to develop more enhanced internal tools to manage and configure our devices. If a customer wants a protocol amendment, we don’t have to download a whole new core product to the devices. Instead, it’s simply a matter of updating the study configuration files and deploying those to the field.”Windows Mobile Windows Mobile brings the power of the Windows operating system to mobile devices, helping businesses and their mobile employees stay connected while on the go. Windows Mobile runs mobile versions of Microsoft programs, including Microsoft Office Outlook Mobile, Internet Explorer Mobile, Pocket MSN, Windows Media Player Mobile, and Microsoft Office

Word Mobile, PowerPoint Mobile, and Excel Mobile. With Windows Mobile, information workers get powerful software combined with the familiarity of Windows. Combined with available service plans and connectivity options, Windows Mobile–based devices, available from 55 device makers and 162 mobile operators in more than 100 countries, can be used to make calls, send e-mail and instant messages, surf the Web, and access critical business information even when users are away from the office.

More information about Windows Mobile can be found at: www.microsoft.com/windowsmobile

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For More InformationFor more information about Microsoft products and services, call the Microsoft Sales Information Center at (800) 426-9400. In Canada, call the Microsoft Canada Information Centre at (877) 568-2495. Customers in the United States and Canada who are deaf or hard-of-hearing can reach Microsoft text telephone (TTY/TDD) services at (800) 892-5234. Outside the 50 United States and Canada, please contact your local Microsoft subsidiary. To access information using the World Wide Web, go to:www.microsoft.com

For more information about invivodata products and services, call (412) 390-3000 or visit the Web site at: www.invivodata.com

This case study is for informational purposes only. MICROSOFT MAKES NO WARRANTIES, EXPRESS OR IMPLIED, IN THIS SUMMARY.

Document published April 2010

Software and Services Windows Mobile 6 Microsoft Visual Studio− Microsoft Visual Studio 2005 Team

Edition for Software Developers

Technologies − Microsoft .NET Compact Framework

Hardware HP iPAQ 210 Enterprise Handheld