PPD Informatics Enters Cooperative Research And Development Partnership With FDA on PPD Patient Profiles

26-Oct-2001

WILMINGTON, N.C., Oct. 25 - PPD informatics, the clinical data consulting services and software solutions division of PPD, Inc., today announced it has entered into a Cooperative Research and Development Agreement (CRADA) with the food and Drug Administration (FDA). The CRADA partnership will focus on further enhancement of PPD Patient Profiles and expanded usage of this graphical display technology in drug safety evaluation. Pioneered by PPD Informatics in 1994, PPD Patient Profiles has since been developed in collaboration with the FDA and pharmaceutical industry for use in analyzing clinical data and identifying potential safety issues in clinical studies. Under this two-year collaboration, PPD will provide the FDA technical consulting and unlimited license to use the PPD Patient Profiles throughout the agency for the analysis and review of submissions and post-market data while the FDA will continue to provide direct input into the future enhancements of this technology. Patient Profiles enables FDA reviewers to evaluate information relevant to a single patient in a clinical trial via a compact graphical display. The clinical data can be pulled from multiple sources and arranged along a common time axis together with notes and highlights facilitating review. The outcome is a concise graphic summary of a patient's data including adverse events, concomitant medications, laboratory results, dosing, vital signs and any other measurement data collected and electronically recorded in a clinical study. Much of the information is presented in a time-aligned fashion, giving reviewers a better understanding of temporal relationships among the various kinds of data. Reviewers can also "drill down" on the graphical display to see underlying data values. "PPD Patient Profiles is a technology that assists FDA reviewers in detection of potential safety issues and trends," according to employees of the FDA's Center for Drug Evaluation and Research. "FDA looks forward to working with PPD to further develop Patient Profiles. As the project develops, we will be asking for volunteers to submit datasets to test Patient Profiles." In addition to entering the partnership with FDA, PPD will launch Patient Profiles to pharmaceutical and biotechnology companies in fourth quarter 2001 as a package of technologies and services for internal single-study or full- submission programs or as an extension to PPD's biostatistical analysis and e- submission services. A number of companies have expressed interest in Patient Profiles to enhance their in-house safety monitoring, facilitate communications with the FDA and assist with the preparation of submissions. "We are excited to be able to incorporate the insight gained from our collaborations with the FDA and our sponsors into a technology that provides a practical tool for analyzing complex clinical data," stated Liz Rolison, vice president of PPD Informatics. "Our focus going forward is to make this technology easy-to-use and accessible to the pharmaceutical industry." PPD Patient Profiles utilizes the company's previously released clinical data visualization technology, CrossGraphs(R), as its technical foundation.

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