Little Falls, NJ (PRWEB) January 18, 2005
Sentrx, a leading provider of technology-enabled solutions and services for global drug safety, and Taratec, a leading consulting company providing regulatory guidance to the life sciences industry, announced today a new offering designed to help pharmaceutical companies understand and document their compliance with pharmacovigilance laws, regulations, and guidances. The Annual Pharmacovigilance Audit combines the regulatory compliance expertise of Taratec with the drug safety operational experience of Sentrx.
The importance of pharmacovigilance, which includes adverse event monitoring during clinical trials and post-marketing, is illustrated in the number of headlines related to the recent withdrawal of a blockbuster drug, as well as in the scrutiny of other established pharmaceutical products. Much of the focus of the press and legal community is on the documentation of how and when companies learned of the increased frequency of adverse events.
At the same time, regulations surrounding drug safety monitoring are increasing. The Good Pharmacovigilance Practices draft guidance is an important component of broader pharmaceutical risk management objectives from the U.S. Food and Drug Administration (FDA). The International Conference on Harmonisation (ICH) Topic E2E: Pharmacovigilance Planning, reached Step 4 in November 2004, which means it is now being implemented in the European Union, Japan, and the USA. This regulatory guideline focuses on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of license application. Compliance with these and other regulations will need to be assessed objectively.
ÂOur clients have told us that pharmacovigilance process and systems auditing is a much-needed service in the biopharmaceutical industry,Â said Joseph Albano, CEO of Sentrx, Âand that our knowledge of drug safety best practices makes us an ideal company to provide that service. We are pleased to partner with Taratec to deliver the Annual Pharmacovigilance Audit.Â
ÂFollowing Good Pharmacovigilance Practices, or GPvP, is essential for a company to demonstrate both internally and to the outside world that it followed the appropriate procedures during development and post-marketing in order to protect patient safety,Â said Steve Jolley, Vice President and Pharmacovigilance Practice Leader of Taratec. ÂThe Annual Pharmacovigilance Audit is an extension of TaratecÂs new risk-based GPvP compliance consulting services and builds on our proven track record in GMP, GLP, and GCP compliance.Â
The Annual Pharmacovigilance Audit will be co-marketed by Sentrx and Taratec. It will evaluate a companyÂs documentation related to:
Â· Adverse event (AE) data received
Â· Standard Operating Procedures (SOPs) followed
Â· Analyses performed
Â· Thresholds met or not met
Â· Actions taken to triage and review potential signals
Â· Subsequent label changes made or not made
In addition, the Annual Pharmacovigilance Audit will evaluate safety systems for documentation on validation, systems life cycle development, change management, adherence to SOPs, and data integrity.
A detailed report will document where GPvPs are being followed and what remedial action may be necessary. With the Annual Pharmacovigilance Audit, biopharmaceutical companies will be able to demonstrate a dedication to quality and patient safety.
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. Through its multilingual Safety Response Center in Little Falls, NJ, 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 http://www.sentrx.com.
Taratec is a leading life science consultancy that provides integrated business, information technology, and regulatory compliance services to innovative pharmaceutical, biotechnology, and medical device organizations around the world. With an extensive suite of services, Taratec enables life sciences companies to bring products to market sooner and improve manufacturing efficiency while achieving compliance with FDA regulations. Taratec is headquartered in Bridgewater, NJ, with offices in Berwyn, PA; Newton, MA; and San Juan, Puerto Rico. For more information, please visit http://www.taratec.com.