International CRO Citoxlab to Further Improve Reporting Quality and Response Times to Sponsors
CONSHOHOCKEN, PA – (BUSINESS WIRE) – March 16, 2015 – –Instem, a leading provider of IT solutions to the global early development healthcare market, announced today that Citoxlab is deploying an extensive package of Instem software solutions to optimize its preclinical workflows and to support CDISC’s Standard for Exchange of Nonclinical Data (SEND).
Citoxlab provides a comprehensive range of preclinical and specialty services from 5 facilities in France, Canada, Denmark and Hungary. Together with its partners, Citoxlab also provides clinical bioanalysis (Atlanbio), embryonic stem cell biomarker discovery and customized preclinical efficacy model services (Stemina).
Citoxlab has recently completed an upgrade to Provantis 9, the latest version of Instem’s world-leading preclinical software solution at its facility in Hungary, with the sites in Canada, Denmark and France all poised to go live this year.
Citoxlab comprehensively evaluated Provantis as they looked to provide an integrated data capture system at each of their sites. This included a requirement for a solution that could convert data from any source system into SEND files and allow sponsors and regulators to share, visualize and analyze study data more efficiently. Instem was chosen for its global market leadership, stability and regional support center.
“We are happy to announce that we have chosen to grow our relationship with Instem with what is a valuable set of solutions,” comments Dr. Jean-Francois Le Bigot, President and CEO of Citoxlab. “This type of innovation, combined with our immediate gains of heightened efficiency, allows us to respond even faster to our clients, with quality results.”
Following issuance by the FDA of the long awaited final Guidance for Standardized Study Data for providing regulatory submissions in electronic format in December of 2014, Citoxlab will implement Instem’s submit™ solution suite at all of its facilities, starting with France and Denmark. Submit™ enables clients to create and manage SEND study datasets throughout their lifecycle and allows sponsors, CROs and regulators to share, visualize and analyze study data more efficiently. Using the submit™ solution suite and aided by Instem, Citoxlab is able to provide study data in SEND format to its clients, and through its example will help the continued adoption of SEND outside of North America.
“It is encouraging to see organizations within Europe continue to embrace SEND following last year’s mandate by FDA,” states Gary Mitchell, VP Global Marketing, Instem “We are seeing a marked increase in the demand for Instem’s submit-SEND solution suite and proudly support more than 30 licensed sites across 11 countries.”
In a further commitment to delivering added value to its clients, Citoxlab is in the process of deploying the Provantis Portal™ Remote Study Monitoring solution. The Provantis Portal will allow Citoxlab’s clients to log in to a secure website using any standard browser to view data from their on-going studies. This will make it easier for clients, particularly international organizations, to monitor their studies remotely, allowing efficient and timely access to study data as well as streamlining communications internally and with Citoxlab.
Citoxlab provides a broad range of GLP and non-GLP preclinical services backed by over 45 years of experience to help their clients meet the demands of today’s complex global marketplace. With five facilities located in France (Evreux, Saint-Nazaire), Canada (Montreal), Denmark (Copenhagen) and Hungary (Veszprem), the Citoxlab group offers a comprehensive range of preclinical services to meet the needs of pharmaceutical, biotechnology and chemical companies worldwide.
Citoxlab carries out studies in general, reproductive and developmental toxicology, carcinogenicity, immunology, safety pharmacology, DMPK and bioanalysis. The group has unique expertise in areas such as toxicology and reproductive toxicology in NHPs and minipigs, inhalation toxicology, radiation studies, and environmental studies (ecotoxicology and those related to REACH regulations).
Through its partnership with Atlanbio, Citoxlab also provides clinical bioanalysis and biomarkers services.
To learn more about Citoxlab, visit www.citoxlab.com
Citoxlab: Safety and Health Research Laboratories
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.
To learn more about Instem solutions and its mission, please visit www.instem.com
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