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Sep 10, 2013

Scitegrity collaboration with several major Pharma companies.

Scitegrity is pleased to announce a collaboration with Pistoia, GlaxoSmithKline, Astra Zeneca, Novartis, Roche and several other companies to develop a system to detect and advice on controlled substances within large corporate compound collections. Please click the article name for more information.

Pistoia Alliance “Controlled Substance Compliance Services” Project

Pharmaceutical companies and other life science R&D organisations routinely work with controlled substances, and must have adequate controls in place to meet the legislative requirements of the countries in which they operate.   Controlled substances include a range of narcotics and psychotropic drugs, which are covered by increasingly complex legislation as legislators attempt to keep up with a rapidly changing environment.  Legislation exists at local, national and international levels to restrict the production, import/export, supply, use and possession of these substances.   This legislation must be interpreted and transformed from legal wording into scientific nomenclature to be used effectively, i.e. words into chemical structures.

The externalization of the Pharmaceutical industry means substances are now produced, stored and transported across many geographies, and it is imperative that life science organisations have a clear, detailed and accurate understanding of the regulations in all regions.  If organisations transgress this legislation then the penalties can be severe, including large fines, lost licences, and damage to reputation.

A working party of pharmaceutical and technology companies has come together under the umbrella of the Pistoia Alliance to define a Controlled Substance Compliance Service (CSCS).   Through the leadership of Rob Lifely (Director, Sample Management) of GSK, project members, including:- The 3E Company, ChemAxon, Patcore, LHASA LIMITED, Binocular Vision,  Roche, Novartis, GSK and Astra Zeneca.

The 3E Company, Scitegrity, ChemAxon, Patcore, LHASA LIMITED, Binocular Vision,  Roche, Novartis, GSK and Astra Zeneca, have defined the requirements for the CSCS.

The key deliverables of the CSCS will be a Legislation Notification Service, a Legislation Knowledge base and an Expert System.   The Legislation Notification Service will send out details of new, updated and clarified legislation to the service customers.   The Legislation Knowledge base will include interpretation of the legislation and detailed guidance information for impacted substances.  The Expert System will determine whether a substance is controlled or not using a set of rules and structures derived from the legislation.

A Request for Proposal to develop the CSCS was issued on the 22nd of April 2013, and five vendors responded.   Following a rigorous selection process Scitegrity was chosen to develope a CSCS service.

Scitegrity is a scientific IT services company with expertise in the management of controlled substances.  The planned release date, when both CSCS instances will be available commercially, is December 2013.

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