Software Products: PPD® Patient Profiles

PPD Patient Profiles software enables you to visualize patient data from clinical trials. It displays patient data along a common time axis together with notes and highlights to facilitate medical review. Leading biopharmaceutical and medical device companies use PPD Patient Profiles to provide insight into safety and efficacy trends, and track unusual values and other relationships within patient data. PPD Patient Profiles works directly with clinical data and shortens the time it takes to generate graphical reports. When reports display, users point and click on any data item to view underlying information.

We worked with the FDA and pharmaceutical sponsors in developing PPD Patient Profiles. FDA reviewers also provided extensive input and guidance towards the continued development of the software through a four-year long cooperative research and development partnership (CRADA) that ended in 2004. Still today, FDA users provide feedback to the tool and its ongoing enhancement.

Key Features of PPD Patient Profiles

  • Time-aligned visualization of trial subject data with supportive information
  • Graphical display facilitates identification of patterns or anomalies
  • User-generated graphs without programming — just point and click
  • Link graphical patient displays with patient narratives stored on the Web or in PDF documents
  • Assists in preparation of exhibits for submissions
  • Graphical display of time-oriented data
    • Associate disparate data elements stored in different files or tables together, graphically
    • Automatically arrange data along a common time axis, in units of days
    • Select a single point in time to align all data relative to this point automatically
    • Display data collected at single points in time, or over intervals of time
    • Color-code events by values of other variables
    • Integrate display of demographic and other data non-time-oriented data
    • Display "timeless" data (data with missing collection time points) along with data collected at known times
  • Import clinical data from SAS, Oracle® Clinical or Clintrial™
    • Directly import data from Oracle Clinical, Clintrial or SAS without programming
    • Software can invoke SAS automatically to convert SAS datasets to transport files
    • Import delimited or fixed-width ASCII files
    • Import SAS transport files; keep SAS data stored externally (no data copying)
    • Import data from any ODBC-compliant datasource including Microsoft® Excel® or Access®
    • Import dBase® files
    • Integrate data from outside of a clinical trials database
    • Not necessary to connect to a clinical trials database management system to use
    • Add data at any time
    • Datasources can contain data from different file types stored in different locations
  • Interactivity
    • Interact with graphical displays through drilldown to view source data or link to associated Web pages or PDFs
    • Drilldown from aggregate graphical reports to patient profile graphs of selected patients
    • Interactively capture key patient information while browsing
  • Output
    • Print graphical reports to any printer
    • Send output directly to Microsoft PowerPoint®, Word® or the Windows Clipboard
    • Output graphical reports as Adobe® Acrobat® PDF documents
  • Reusability and portability
    • Data and graphical formatting are stored separately, supporting reuse of reports with data from different studies
    • One click is all that's needed to update from the latest version of data
    • Freely move graphical reports and datasources between directories or workstations
  • 21 CFR Part 11
    • 21 CFR Part 11 compliant. Audit trails contained within designs and datasource files
  • Used by the FDA
    • Developed with critical input from the FDA
    • Used by medical reviewers at the FDA 

System Requirements for PPD Patient Profiles 

When installed on the user's PC, the system requirements are: 
  • Operating system: Windows® NT, 2000, XP, Vista, Server 2003  
  • Disk space: 35 Mb 
Sharing the application can be done either via Citrix or by simply installing it on a shared network drive and doing some minor configuration on each user's PC. In that case, the system requirements are:
  • Operating system: Windows® NT, 2000, Server 2003 
  • Disk space: 35 Mb
Mike Wilkinson, Ph.D., executive vice president & chief information officer, shares how PPD enhances quality, increases data transparency, speeds decision-making and reduces costs.