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Global Pharmaceutical Client Orders SENDReady™ Analysis
Highly Targeted Consultancy Exercise Supporting FDA SEND Initiative
CONSHOHOCKEN, PA - (BUSINESS WIRE) - February 28, 2008 - - Instem, a premier global information solutions provider, announced today that in support of their involvement in the FDA SEND1 pilot, an international pharmaceutical client has placed an order for Instem’s exclusive SENDReady™ Analysis, which will be conducted during the second quarter of this year.
Instem’s SENDReady™ Analysis is a highly targeted and structured consultancy exercise that gathers and presents the business case and opportunities relating to the implementation of a SEND solution. The methodology employs a blend of questionnaires and interviews to gather information, which is then combined with the knowledge and experience of Instem consultants to provide clients with a written report of findings. The process is efficient, time conscious and focused on the specific business needs of clients.
The fixed-price SENDReady™ Analysis delivers specific recommendations including an overall vision, business goals & benefits, user roles, source systems analysis, SEND gaps, solution outline, functional-fit check list and a comprehensive project plan.
Instem is working closely with CDISC (Clinical Data Interchange Standards Commission) and industry leaders to advance FDA’s initiative and is committed to providing clear guidance to customers.
About Instem
Instem is a world-leading information solutions provider for the Life Sciences – accelerating drug and chemical development by increasing client productivity and enhancing the processes that lead to safer, more effective products.
As well as highly focused departmental and scientific solutions, Instem provides a range of Business Intelligence, Planning, Workflow Management, Dosage Formulation, Document Management and Report Compilation applications. In a highly fragmented Life Sciences IT market, Instem is one of very few organizations that have clearly developed the financial strength necessary to maintain global leadership with established products, while introducing new applications that can deliver the step change in productivity that clients are aggressively pursuing.
1 SEND (Standard for Exchange of Nonclinical Data) is an electronic standard for the exchange of toxicology and carcinogenicity data in a standardized format. SEND is being developed with FDA under the auspices of CDISC (Clinical Data Interchange Standards Consortium). The most recent version of SEND, version 2.3, is available at CDISC’s website at www.cdisc.org/standards. SEND v2.3 is an Implementation Guide for single-dose, repeat-dose and carcinogenicity studies. SEND v2.3 has been tested in pilot projects by the FDA’s CDER division and nine industry participants.
Press Contact:
Gary E. Mitchell, VP Global Marketing, Instem US HQ
Tel: (610) 941-0990
Email: gary.mitchell@instem-lss.com
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