Pilgrim Adverse Event Regulatory Reporting Management

Overview

A Complete Regulatory Platform for Clinical and Post-Market Adverse Event Management for Drugs, Device & Combination Products

As globalization continues to press outward, regulatory agencies worldwide are looking to improve the efficiency of their operations and support early signal detection. As a result, regulations are changing, electronic reports are increasing, and the codes and the structure of how data is used, linked, and made available through product value chains will continue to expand. Pilgrim Software’s Adverse Event Regulatory Reporting Management solution will ensure that manufacturers are able to: maintain compliance; increase operational effectiveness; and, quickly identify product safety issues while avoiding risk and sustaining quality, now and as regulations continue to evolve.

regulatory_reporting

Key Capabilities

Pilgrim’s Adverse Event Regulatory Reporting – Key Capabilities

Proactive Intelligence on Product Safety

Pilgrim’s Adverse Events Reporting solution allows medical device, drug and combination product manufacturers to readily identify adverse events before they become critical issues, facilitating proactive risk avoidance and product regulatory and safety adherence. The solution enables automated data collection for adverse events from the very moment of awareness. Using configurable decision trees and automatic links to product labeling (IFU/catalogs/sample cases), management can make informed decisions on whether those issues require reporting to regulatory bodies. Pilgrim’s unique integrated solution allows a company’s entire value chain to capture adverse events within a single environment with the ability to analyze, trend and report on safety data to support early signal detection.

Out-of-the-Box Forms & Electronic Reporting

The solution provides out-of-the-box reports and data, and pre-built regulatory forms for regulations including FDA MedWatch 3500a (ADE and eMDR), CIOMS I, EU MEDDEV, Canada MDPR, Australia TGA, Japan ARR, and Germany BfArM. Users also have the ability to create their own Regulatory Report templates for any country’s regulatory requirements as needed to drive increased usability across the global organization. Pilgrim provides the capability for eMDR electronic submissions of post-market medical device reports to the FDA. The eMDR Electronic Submission capability expedites adverse event reports for the FDA using XML technology and complying with HL7 standards. Such capabilities are also included for required evaluation of adverse incidents and e-submissions among European medical device manufacturers to comply with the eMDV reporting requirements.

MedDRA Dictionary Integration

Pilgrim’s Regulatory Reporting solution is integrated with the MedDRA dictionary to ease and expedite the reporting process. The MedDRA dictionary is the “standard” for adverse event Pharmacovigilance terminology. The intelligent integration capability of Pilgrim’s tool captures any version of a MedDRA term to maintain consistent terminology for reporting throughout a product’s clinical trial lifecycle. Through a seamless integration, the tool can automatically capture MedDRA terms at any point in the process and automatically populate information into the case record for annual analysis and data mining, from the lowest level term (LLT) to preferred (PT) to SOC. Pilgrim's Complaints Management solution then auto-populates the MedDRA terminology into the appropriate regulatory reports. Using the solution’s Advanced Search capability, the integration allows the user to search and select the Preferred Term/Code from the MedDRA dictionary (LLT/PT/SOC).

Integrated Product Safety Database

Pilgrim’s Regulatory Reporting solution seamlessly allows the escalation to a CAPA based on the evaluation of the event. The solution supports streamlined investigations though its product safety database that is a repository of information throughout the product's lifecycle. This enables investigators to examine the NCMRs and previous complaint information, check across lots/serial numbers, and pull information from external data sources for thorough analysis. This automated association process supports both simple resolution and CAPA-driven resolution models. It also includes risk mitigation capabilities such as failure mode monitoring to identify any immediate trends so issues can be stemmed and trends reversed. The solution also allows the user to leverage data from a Risk Management file to standardize on coding for product safety analysis, and then feed back information into the Risk Management file for new product development. Because the solution can be integrated enterprise-wide, it makes it possible to capture events from any source; for example, clinical trial management adverse event escalation, call center escalations or evaluations, intranet forms for company-wide communication, or internet for direct customer feedback, as input into the company’s common Safety database. Having a central database for product safety information, from the receipt of the raw material, through the manufacturing life-cycle, to the customer experience, allows for a detailed analysis of all the product safety data that can help support effective root cause analysis. In addition, the ability to integrate seamlessly into other databases for silos of product safety information also supports a more thorough investigation process.

Reports and Analytics

Pilgrim’s Regulatory Reporting solution includes out-of-the-box reports and ad-hoc queries for complaints, including Line Listing & Summary Tabulation Reports (following ICH standards) that provide the ability to identify Adverse Events by System Organ Class (SOC) term and a count of Serious vs. Non-Serious Adverse Drug Experiences (ADE) submitted over any given period of time for all cases reported. Pilgrim’s report writer capabilities enable users to quickly gain visibility into all their adverse event data by allowing them to develop, format, and control the content, and publish the reports, including the data for Periodic Safety Update Reports (PSUR), to the right users. Extreme reporting flexibility allows users to create any type of log reports, including consolidated or summary reports, in one simple drag-and-drop mode, and in a point-and-click style. Pilgrim’s solution also allows the user to easily create new analytics and dashboards, and keep a pulse point on their regulatory reporting processes.

Features & Benefits

Pilgrim Adverse Events Reporting Management -- Key Features & Benefits:

Capabilities	Benefits
Improve Productivity
Web-based	Standardize adverse event reporting processes through a streamlined, closed-loop, globally available and compliant process
	Execute timely, consistent and high-quality global investigations, analyses and regulatory reports for any member of your global team
Out-of-the-box reports/forms	Pre-built eMDR forms expedite submissions to FDA Gateway
	Pre-built eMDV forms expedite submissions to European regulatory bodies
	Shorten the complaint/adverse event and coding process
	Perform analysis on adverse events and product issues to proactively identify patterns, signals and improve product safety
	Report writing capabilities expand user visibility and control of published reports, analytics and dashboards
	Reduce the amount of time required to create the data necessary to create PSUR reports
Global Reporting and Analytics
	Global adverse event classification - Ability to classify events as 'Serious Expected' for Agency 1 and 'Serious Unexpected' for Agency 2; Results available for complete global reporting analysis; Add regulatory reports and decision trees from any country
MedDRA Dictionary Integration
	Search MedDRA terms more quickly using a fully integrated browsing and coding tool into the case record
	Launch to MSSO MedDRA-supported dictionary via URL on complaint intake form
	Eliminate human errors of other coding tools
	Supports multiple languages to support foreign regulatory reporting requirements
Manage Quality, Risk & Compliance
	Manage regulatory and quality across entire business and product lifecycle through seamless integration with other Pilgrim Quality functionality
	Reduce safety risk for multiple product types including drug, device and combination products
	Full audit trail tracking, query and reporting capabilities
	Out-of-the-box configurable decision tree for each country and report
Complete Visibility / Transparency
Enterprise-wide Access	Users across multiple sites, departments and functions access Adverse Event & Product Safety data and report content in real-time
Integration with Core Systems	Integration with Enterprise Risk, Compliance & Quality platform, including Complaints management, CAPA management, Document Control and Audit management, for complete management of your quality and regulatory compliance
	Full visibility of nonconforming product along the product lifecycle and concessions to aid in driving to root cause during investigations.
Validation
Validation and Management at Every Step in the Process	Validate type of data and required data in case / event intake
	Validate data format, lengths, etc., in electronic submissions to Regulatory Standards

Resources

Product Information

Screenshots

Customer Information

Recorded Webinars

CDRH eMDR to be Made Mandatory. Are You Ready?

White Papers

Complaint Management in the Medical Device Industry: Effectively Handling Complaints

Adverse Events Reported to FDA via its MDR Program

The Future Is Here: Electronic Medical Device Reporting