SENTRX Selected as Drug Safety Partner by PRAECIS PHARMACEUTICALS INCORPORATED: Specialty Firm Will Provide Pharmacovigilance
And Risk Management Services
SENTRX, a leading provider of technology-enabled solutions and services for global drug safety, announced today that it has signed agreements with PRAECIS PHARMACEUTICALS INCORPORATED to perform post-marketing safety and risk management services, as well as safety system hosting.
(PRWEB) February 22, 2004 --PRAECIS recently received approval from the United States Food and Drug Administration (FDA) to market Plenaxis (abarelix for injectable suspension), the first of several drugs in their pipeline to reach the market. SENTRX will provide drug safety operations for this important new product and will implement the PLUS (Plenaxis User Safety) Program.
PRAECIS needed to leverage a partner with deep experience in pharmacovigilance," said William K. Heiden, President and Chief Operating Officer of PRAECIS. We selected SENTRX because they are completely focused on drug safety, they understand how to apply technology to pharmaceutical support programs, and they were able to meet our aggressive timetable for launch."
Utilizing a dedicated team of health care professionals in their Safety Response Center, SENTRX will provide the following services:
·Intake and data entry of adverse events (AEs), serious adverse events (SAEs), and events of interest obtained via phone, fax, mail, e-mail, literature searches and through the PLUS Program;
·Active query of patients and health care providers to obtain complete case information;
·MedDRA coding, narrative writing and medical review;
·Expedited and periodic report preparation;
·Handling of medical inquiries, frequently asked questions (FAQs), and product complaints;
·Installation, configuration, validation and hosting of a dedicated instance of the Argus Safety System;
·Configuration, validation and hosting of a Web-based system for medical inquires, product complaints and FAQs;
·Configuration, validation and hosting of the Plenaxis PLUS Program registry; and
·Telephone support to physicians, hospital pharmacists and authorized distributors for PLUS Program registration, confirmation and adverse event reporting.
SENTRX built the Plenaxis PLUS Program registry utilizing its ultra-secure, Web-based SafetyTrak® Technology Suite, which allowed the system to be operational and validated in 60 days. Specialty distributors will access the registry to confirm a medical professionals participation in the PLUS Program before shipping product.
We are excited to work with PRAECIS, an innovative company that has made patient safety its number one priority," said Joseph Albano, Chief Executive Officer of SENTRX. The rapid deployment of our technology and service offerings will allow Plenaxis to reach appropriate patients as quickly as possible."
About PRAECIS
PRAECIS PHARMACEUTICALS INCORPORATED is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies to address significant unmet medical needs. In the United States, PRAECIS has received approval from the FDA to market Plenaxis (abarelix for injectable suspension). PRAECIS employed its proprietary LEAP (Ligand Evolution to Active Pharmaceuticals) technology in the development of Plenaxis. PRAECIS also has an innovative product pipeline, including clinical programs in Alzheimers disease, non-Hodgkins lymphoma and endometriosis, as well as discovery programs in oncology, inflammation and anti-viral therapies. PRAECIS is headquartered in Waltham, MA.
About SENTRX
SENTRX is a leading provider of technology-enabled solutions and services for global drug safety. Its mission is to manage the safety risks associated with developing and marketing pharmaceuticals. With multilingual Safety Response Centers in the United States and Europe, SENTRX delivers a unique combination of highly skilled people, exclusive technology, and best practices in pharmacovigilance and risk management. To learn more about SENTRX, please visit their website at www.sentrx.com; send an e-mail to info@sentrx.com; or call 1-888-399-8032, extension 261.
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