Pilgrim Software Launches Integrated Platform for Regulatory Reporting

TAMPA, Fla.--(EON: Enhanced Online News)--Pilgrim Software, Inc., a world-leading provider of Enterprise Risk, Compliance and Quality Management (ECQM) software solutions, today announced the global availability of its expanded Regulatory Reporting platform. Rounding out the platform, the MedDRA adapter is the newest capability from Pilgrim, integrating with its Complaints Management solution to ease adverse event reporting to global regulatory bodies.

“Further, companies that adopt Pilgrim’s Regulatory Reporting platform will benefit from a resulting increase in the accuracy and productivity of their Pharmacovigilance by reducing time spent addressing errors and the man-hours to pull together all the data and analysis necessary for periodic safety reports.”

Pilgrim’s integrated solution allows companies to capture their products’ inquiries, complaints and adverse events within a single environment that allows for the ability to analyze, trend and report on safety data anywhere throughout the product lifecycle. The MedDRA adapter supports the reporting process by allowing Pilgrim’s Complaints Management users to easily access the MedDRA Dictionary of terms (codes) to quickly update required MedWatch Adverse Event Reports.

“As globalization continues to press outward, many regulatory agencies are looking to improve the efficiency of their operations,” said Atulya Risal, Pilgrim Software’s Chief Technology Officer. “As a result, regulations are changing, electronic submissions are increasing, and the codes and the structure of how data is used will continue to expand.

"By ensuring that manufacturers are using the latest accepted terminology and helping to provide clear, concise, complete and accurate data in their reports, the MedDRA capability supports ongoing compliance with reporting needs now and as the regulations continue to evolve.”

The MedDRA Dictionary integration capability enables users to capture any of the 70,000-plus MedDRA terms, at any version and using any language, to support the reporting of Adverse Events throughout the clinical trial to post-market product lifecycle. It automatically captures all the MedDRA terms for the patient symptom into a record to support the periodic safety analysis, and Pilgrim’s Advanced Search feature allows for quick analysis of records containing MedDRA terms.

“Pilgrim’s Regulatory Reporting solution allows 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,” said Prashanth Rajendran, Pilgrim’s Chief Operating Officer. “Further, companies that adopt Pilgrim’s Regulatory Reporting platform will benefit from a resulting increase in the accuracy and productivity of their Pharmacovigilance by reducing time spent addressing errors and the man-hours to pull together all the data and analysis necessary for periodic safety reports.”

Pilgrim Software is on the forefront of automated regulatory reporting and has developed a global reputation for its expertise in this area. In developing its current adverse event “Regulatory Term” management solution, Pilgrim Software is sharing its design of the hierarchical capabilities for the new CDRH event codes with the FDA. Pilgrim will also be involved when the MedDRA team implements bringing the new CDRH codes into the MedDRA Dictionary.

About Pilgrim Software, Inc.

Pilgrim Software, Inc. is a world-leading provider of Enterprise Compliance and Quality Management solutions for global organizations. Named 2007 & 2008 North American Enterprise Compliance & Quality Management Company of the Year by Frost & Sullivan, Pilgrim helps organizations manage industry and regulatory compliance, reduce manufacturing costs and improve customer satisfaction. For more information, visit Pilgrim Software’s website at www.pilgrimsoftware.com.