Instem to Present at 6th Annual AsiaTox Conference, Sendai, Japan
Instem Presenting on Acceptance Status and Future Deployment Plan of SEND Format by FDA
CONSHOHOCKEN, PA - July 12th , 2012 - - Instem, a leading provider of IT solutions to the global early development healthcare market, is pleased to announce that Instem Consultant, Jonathan Sparkes will be presenting at AsiaTox VI, the 6th International Congress of the Asian Society of Toxicology, taking place in Sendai, Japan, from July 17th-20th.
The presentation will outline the current acceptance status and future deployment plan of the SEND (Standard for Exchange of Nonclinical Data) format by the FDA and will also look at how the SEND initiative facilitates data cooperation between pharmaceutical organizations and contract research laboratories (CROs).
FDA reviewers continue to receive mostly paper or electronic paper (PDF) submissions. Manually entering this data for further analysis is seen as time consuming and inefficient, taking time away from the primary mission of reviewing the content of submissions to asses and ensure the safety of the drug that is being tested. The SEND format enables more efficient review of nonclinical data, offering improved data quality, accessibility and predictability.
Using data in SEND format, industry can help improve the safety review process while streamlining the flow of data from collection through submission and facilitate data interchange within their organizations and with external study partners.
“I am delighted to have been invited to speak on this topic,” commented Mr. Sparkes, “Instem has been a leading participant in the SEND initiative from the outset and it is a subject that is being keenly watched by research organizations throughout the Asia Pacific region.”
To help see the standard propagated throughout pharmaceutical companies and CROs worldwide, Instem has been providing education and outreach to promote SEND while demonstrating its own technology solution suite – submit™. Industry is now actively embracing the SEND solution and Instem clients are utilising submit™ to create and manage their SEND study datasets.
AsiaTox VI takes place in conjunction with the 39th Annual Meeting of the Japanese Society of Toxicology and the focus of this year’s conference is Risks versus Benefits of Organic Chemicals, Drugs, Metals and Natural Products.
Instem will also have an exhibitor presence at the conference, where they will be sharing a booth with CTCLS, their Japanese distributor. CTCLS is one of Japan’s leading providers of integrated R&D support systems for the life sciences, supporting Instem’s solutions through their full service offices in Tokyo and Osaka.
About Instem
Instem is a leading supplier of IT applications to the early development healthcare market, delivering compelling solutions for data collection, management and analysis across the R&D continuum. Instem applications are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making leading to safer, more effective products.
Instem’s portfolio of software solutions increases client productivity by automating study-related processes while offering the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.
Instem supports over 400 clients through full service offices in the United States, United Kingdom and China with additional locations in India and a full service distributor based in Japan.
Meeting clients at the intersection of investment & return™.
Press Contacts:
Instem
Gary Mitchell (US HQ)
gary.mitchell@instem.com
Tel: 610-941-0990
Julie Jones (UK HQ)
julie.jones@instem.com
Tel: +44 (0) 1785 825600