Back in March I wrote about their own internal software that I believe was primarily imageput together for both clinical and tracking areas and now it looks like the definitive business intelligence area of reporting and compliance is added to the equation.  As the company after a few rocky years settles in to actually sell their processes for anti immune treatment of prostate cancer and the life prolonging benefits, it seems and entire package was needed to document and report all.  The process being a brand new type of drug where blood specimens are sent back and forth from the patient makes tracking and reporting very critical. 

Dendreon “Intellivenge” Algorithmic Software Supporting Administration of Pimagerovenge – Seeking FDA Approval by May 1st

In addition to the normal FDA compliance areas I am guessing the blood and tissue compliance area might also be under the eye of the FDA too, again just simply because of what the process is and how it is administered and is not just taking a pill or getting an IV.  Several large biotech and life sciences companies are listed as customers for Pilgrim.  BD

TAMPA, Fla.--(EON: Enhanced Online News)--Pilgrim Software, Inc., a world-leading provider of Enterprise Risk, Compliance and Quality Management (ERCQM) software solutions, today announced that Dendreon Corporation, a Seattle-based biotechnology company, will implement Pilgrim’s automated system for Deviation and Corrective and Preventive Action (CAPA) management using its on-demand software as a service platform.

“In addition to providing Dendreon with automated processes, our solutions also provide them with the scalability to easily integrate additional modules and increase the number of users as they expand.”

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In addition to the CAPA solution, Dendreon also will implement Pilgrim’s solutions for change control management, audit tracking, regulatory commitments and customer complaints, and SmartInsight, Pilgrim’s Business Intelligence tool for generating business user-centric compliance and quality management reports.

Biotechnology Company, Dendreon Corporation, Selects Pilgrim Software’s On-Demand Solutions | EON: Enhanced Online News

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