Prelude Adverse Events Reporting System

PAERS is a medical complaint tracking system that can be used by manufacturers of drugs, devices and biologics. The system is specifically designed to facilitate the entry and tracking of all Case information. It provides a full complement of standard reports, an ad-hoc reporting and analysis system, and all FDA mandated reports.

PAERS features:

• Tabbed entry for easy access to all case related information. Tabs include: Case information, Patient, Other personnel, Product, Concomitant, Medical tests, Medical history, Medical Devices, Regulatory Reports and Serious.
  
• On-line help information is available for every entry field. Additionally, many of the entry fields also display pop-up tips to facilitate entry as the mouse is moved over the field.
  
• Wherever possible, entry information is validated. Examples include date fields, such as the Regulatory Submissions date which may not precede the Case Status determination date. Extensive use of look-ahead pull-downs ensure that only valid information is selected and entered. All the pull-down choices are definable by your institution and can be managed by the Medical Affairs administrator.
  
• Information in the COSTART, WHOART, WHODRUG and ICD-9 Dictionaries can be accessed from high-speed search forms. Once a term is selected all the information related to the term is posted to the correct Case fields.
  
• Customizable business rules for managing Case Correspondence to both Patient and all medical personnel associated with the case.
  
• All Case Entry information is audited. The Date, Time, User and Reason for change is captured as well as the value of the fields both before and after the change.
  
• Implementation of standard Letters and Questionnaires based on user defined business rules to manage requests and follow-up letters.
  
• The Action tab provides the Case manager with an organized means of entering Personnel contact notes and other information related to the case. Multiple standard or custom letters can be entered and managed using this tab.
  
• Extensive standard reports for reviewing case information. Both date-range and product information can be used to filter reports.
  
• FDA-approved MedWatch for Drugs and Medical Devices reports. International reporting with CIOMS-1 and CIOMS-II.
  
• Extensive use of Support forms and Main Menu accessed routines to easily manage special functions. Some examples are: Case locking, Case Archiving, Case copying, and management of the institution's Product information.

A demonstration of the Prelude Adverse Events Reporting System can be arranged by contacted our Business Development Team.

Prelude Computer Solutions, Inc., 26 Hill Road, Parsippany, NJ 07054. Tel: 973-331-3740; Fax: 973-331-3741.