Have a question about Phoenix Data Systems? Find your answers here.
Is Phoenix Data Systems a public or privately held company?
Phoenix Data Systems is a division of a public company, Bio-Imaging Technologies, Inc. (Nasdaq: BITI).
How many EDC trials has Phoenix Data Systems managed?
Over 600 successful trials to date, as of August 2008.
Has the data collected been used in any FDA submissions or approvals?
Yes. Our EDC products were used to manage pivotal trials for 13 NDAs (as of March 2008), including a number of FDA approvals.
Does Phoenix Data Systems have any international experience?
Yes. In addition to extensive deployments in North America and Europe, our solutions have also been deployed in Africa, Australia, South and Central America and Asia.
What is “Full Service EDC”?
Full Service EDC, offered exclusively by PDS, is the ultimate combination of technology, data management services and clinical trial expertise. We call it Full Service, because we do it all for you. Our unique approach helps you get the most from your data, 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.
Learn more about Full Service EDC.
Who supports the EDC application and sites with Full Service EDC?
Full Service EDC employs a Managed Service Provider (MSP) approach to extend the value of a traditional ASP model with a menu of high-value services in addition to basic operation of the application. This way, our MSP model lets you start faster and run leaner because it does not require the sponsor to operate the infrastructure or run the applications in-house.
Learn more about Full Service EDC.
But won’t we lose control if we don’t do Data Management?
No. Although our clinical data specialists manage all the data, with Full Service EDC you stay in complete control and even have continuous access to all your data, all the time. We also provide tools and reports to give you total transparency into your study’s progress and foster a vendor-sponsor relationship based on clear communication. The PDS Reportal™ provides you with current information to better manage all your vendors, including PDS.
Learn more about Full Service EDC.
Do you have a help desk?
Yes, we provide all our clients with a scalable, well-defined global support process. Our experts are responsive, available 24/7 and have deep industry expertise to ensure your success. They’ll help resolve site or sponsor issues quickly and completely and provide assistance every step of the way — from installation, to maintenance to support.
Can the PDS system integrate or export to Clintrial™ or Oracle® files?
Yes, we can — we’ve done it routinely for years. Our core EDC product, PDS Express™, can export to any ADO-compliant database including Clintrial or Oracle, if desired. In addition, since the FDA currently requires SAS® as a reporting medium, SAS is a de-facto requirement in the pharmaceutical sector. To meet this requirement, PDS Express consolidates your trial, pre-trial, lab and instrumentation data and exports the clean data directly to SAS using SAS transport files.
How does clinical trial safety data map to the Serious Adverse Experience (SAE) safety data for expedited reporting?
PDS Express highlights Serious Adverse Experiences and other monitored events and leads the sponsor and PI to the appropriate reporting. It also triggers the creation of a separate database and the automatic generation of a MedWatch 3500A or similar form. PDS Express tracks SAEs and reconciles the SAE database with the overall safety database.
Are your offerings compatible with the CDISC ODM XML standards?
Yes. In fact, we are a CDISC member, and comply with all current CDISC guidelines. Our PDS Express product is compatible with all CDISC standards. PDS Express is designed to export data structures into standard CDISC structures, and we are committed to supporting these standards in all future developments. We also maintain a library of standard CDISC forms that are compatible with the operational data model.
Can you recommend a CRO that knows Phoenix Data Systems technology?
Yes. PDS has worked with many CROs and we can recommend one that is best for your needs, your sponsor’s needs, and that is relevant to the therapeutic area under research.
Do you use third party vendors in the development or maintenance of PDS products?
No. All development and maintenance is provided exclusively by Phoenix Data Systems staff. However, we have a partnership with SunGard® to support our global network and infrastructure including, networking, application hosting, security and backups for our ASP services.
How can I learn more?
For more information on Phoenix Data Systems, Full Service EDC or any of our other eClinical solutions, call 484.928.6000. Or complete our contact form and a PDS representative will be in touch soon.
