1. What is "Full Service EDC"?

Full Service EDC is the ultimate combination of technology and clinical experience. Our one-stop solution delivers all the technology, data management and clinical experience you need. Delivering faster start-up and consistently exceeding paper options. Providing flexible and proven technology for cleaner data faster - with real-time visibility so you can reach faster proof of concept or "no go" decisions quicker.

Full Service EDC is more than just EDC technology. Our expert Data Management Services and deep clinical expertise in a wide range of therapeutic areas help you get the most from your data. Maximizing results. Efficiency. Savings. All with a minimum of vendor paperwork. Our Data Management services complement your in-house resources and our Help Desk analysts support your study globally with 24/7 technical assistance.

It's called Full Service, because we do it all for you. So there's no learning curve or resource overload. Just the data you need for faster database lock, reports and submissions - all at a predictable price.

2. How is Full Service EDC different than EDC from other providers?

EDC Vendors offer technology - technology that requires specialized knowledge, customization, implementation, hardware, training, technical support, and other considerable resources. Full Service EDC makes it easy. Easy to gain the speed and quality advantages of EDC without the huge resource overload, risk, or IT investment. That's because we manage the technology for you. So there's no learning curve, no training, just the data you need. And Full Service EDC delivers more than just technology. We deliver a total solution, including data management and clinical expertise in a wide range of therapeutic areas.

If you are considering an EDC Vendor, make sure you look realistically at the cost of buying and supporting any enterprise solution in-house. The value lost because of the time required to build and master the technology, combined with the cost of a high rate of technology change, usually exceeds the cost of the basic application by ten times or more.

Some technology vendors and service providers even go so far as to promote 'hybrid' trial designs that involve both paper and EDC components. However, these are effectively nothing more than paper trials that use the EDC system only for data management. They are more complex to manage and more expensive to run because they require two processes for every step of the data capture process - and two change orders for every modification.

3. Who supports the EDC application and the sites with Full Service EDC?

Even the largest pharmaceutical companies with extensive IT resources have struggled to implement eClinical solutions. That is because the challenges are bigger than just the technology. A Managed Service Provider (MSP) extends the value of the ASP model with a menu of high value services in addition to the basic operation of the application. Phoenix Data Systems' MSP model allows you to start faster and/or run leaner than might otherwise be possible. Full Service EDC does not require the sponsor to operate the infrastructure or run the applications in-house.

We partner with SunGard Availability Services to provide sponsors with world-class telecommunications and networking at a very reasonable cost. Our servers are connected to your network and your sites via a global network backbone that delivers maximum redundancy, reliability and security. Our applications are supported with high levels of security and reliability through proactive monitoring and management. Together, we support you using state-of-the-art IT tools and industry best practices to keep an eye on your resources around the clock. With Phoenix Data Systems' hosted services you can confidently choose to keep your IT efforts focused on other strategic initiatives and leave the technical infrastructure support for EDC to us.

4. How is Full Service EDC different from the service provided by a CRO?

Many clinical outsourcers still prefer paper and only do EDC part of the time. Their experience is often spread across different systems and teams. At Phoenix, we do EDC all of the time. We're EDC experts. Our ability to better understand the technology means we can conduct trials faster and more efficiently. Our EDC technology is proven and delivers fast, accurate results so you get access to your data quicker.

Full Service EDC is a flexible solution. Delivering real-time visibility so you can reach faster proof of concept or "no go" decisions quicker. Most importantly, unlike providers that charge for every change order, Full Service EDC delivers study flexibility at a predictable price. In fact, in supporting nearly 400 trials, we've never had a cost overrun.

5. What are the benefits of Full Service EDC?

The benefits of Full Service EDC deliver huge speed advantages and business advantages. Benefits include:

• Faster start-up
• Flexible, proven technology
• Better compliance
• Higher quality data
• Early and real-time access to clean data
• Faster database lock
• Predictable pricing

6. Who offers Full Service EDC?

Phoenix Data Systems is the only provider of Full Service EDC. Our unique solution combines proven EDC technology, deep clinical expertise in a wide range of therapeutic areas, and strong data management to get you clean data, faster.

7. Is Full Service right for my company?

In today's world of diminishing profit, increased competition and time-to-market pressure, more and more companies are looking for ways to increase efficiencies, reach no-go decisions quicker and manage their resources more effectively. If this sounds like your company, then Full Service is right for you. Our unique combination of technology and clinical expertise means that you get data faster, with better safety and control, and at a predictable price. We can provide the resources and experience you need for a successful clinical trial.

8. Won't we lose control if we don't do Data Management?

Although our clinical data specialists manage all the data, the sponsor has complete and continuous access to all of the data, all of the time. Tools and reports provided by PDS technology provide complete transparency into your study's progress and foster a vendor-sponsor relationship based on clear communication.

9. I'm a clinical researcher. How would Full Service EDC help me in my job?

Clean data. Lower costs. Improved management for your clinical trials. Full Service EDC is the only complete clinical trial solution available to reliably get these results. And it delivers relief from a lot of technical and operational particulars that lets you concentrate on the science.

Our technical flexibility makes high performance Electronic Data Capture possible even when connectivity options are less than ideal. You get your critical reports when you need them - sooner. Our straightforward user interface eases training and improves site efficiency. Now you can keep your investigators happy, monitor protocol compliance, close clinical trial studies faster, and simplify compliance with all regulations and guidelines.

We also complement EDC with Interactive Voice Response solutions that extend your ability to capture more of your clinical data electronically. The unique design of PDS IVR integrates randomization results or any other IVR data within the EDC database, eliminating data entry and reconciliation requirements. Providing you with clean and integrated data - without the hassle of integration. Putting your data and your trial metrics all in one place. Faster.

Full Service EDC supplements your organization with Electronic Data Management services that complement your in-house resources and supports your study globally with 24/7 technical Help Desk. All of this is available at a predetermined price that helps you manage costs and reduce the vendor paperwork.

10. Where can I get more information about Full Service EDC?

We'd be happy to talk to you about the benefits of Full Service EDC. For more information, call: 484.928.6000 or email us at: info@pdsedc.com.