Adverse event reporting requires the tracking of all medical complaint case information, culminating in the generation of MedWatch reports, CIOMS reports, and other internally generated reports. 

Prelude's Adverse Event Reporting Software (PAERS) is an affordable way to manage drug safety information and MedWatch reporting for FDA compliance. The Adverse Event Reporting Software for medical complaint tracking can be used by manufacturers of drugs, devices and biologics.

Specifically designed to facilitate the entry and tracking of all case information, PAERS provides a full complement of standard reports, ad-hoc reporting, and all FDA mandated reports.

Adverse Events

Manage event information from on-set to FDA reporting:

• Patients, doctors, pharmacists, product, medical device, indications, concomitant, medical tests and history, symptoms, seriousness, outcomes, contact information, and regulatory submission tracking.  

• Utilize the MedDRA, COSTART, WHOART, WHODRUG and ICD-9 Dictionaries for high-speed forms based searches. Post terms to appropriate case fields.

• On-line error detection to ensure accurate data entry.  For example, date fields must contain valid dates and several critical date fields are validated against related date information. The Regulatory Submission date cannot occur before the Case Status date is determined.

• Extensive use of look-ahead pull-downs to ensure that only valid information is selected and entered. All pull-down choices are definable by your institution and can be managed by the Medical Affairs administrator.

• All case entry information is captured in the audit trail. The date, time, user and reason for change is captured as well as the value of the fields both before and after the change.

• FDA-approved MedWatch for Drugs and Medical Devices reports. International reporting with CIOMS-1 and CIOMS-II.

• Special functions available for case locking, case archiving, case copying, and management of the institution's product information.

Case Management

Automatic rules based follow up and due diligence:

• Customizable business rules for managing case correspondence to both patient and all medical personnel associated with the case.

• Implementation of standard letters and questionnaires based on user defined business rules to manage requests and follow-up letters.

• Contact management to organized personnel contact notes and other information related to the case. Multiple standard or custom letters can be entered and managed using this function.

• Extensive standard reports for reviewing case information. Both date-range and product information can be used to filter reports.

• 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.

The Prelude Consumer Affairs Software (PCARS) is the companion product to PAERS and provides a complete consumer complaint tracking system for the Consumer Affairs department.

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