Centrus Contract Win with Top 10 Pharma
03 December 2012
("Instem", the "Company" or the "Group")
Centrus Contract Win with Top 10 Pharma
Leading Global Biopharmaceutical Company Purchases Instem's Centrus Software to Convert, Create and Share Research Study Data
Instem plc (AIM: INS), a leading provider of IT solutions to the global early development healthcare market, announces today that it has signed a contract with one of the world’s largest biopharmaceutical organisations. The customer has purchased multiple modules of the Centrus software suite supporting the Standard for Exchange of Nonclinical Data (SEND). This six-figure US Dollar order is the most comprehensive suite of Centrus modules purchased to date.
Instem’s software will be used to reduce time and effort by translating study data to controlled terminology and automatically checking against SEND guidelines to ensure compliance. Additionally it includes the capability for the management, secure storage and sharing of SEND datasets with external partners.
The SEND standard, named by the US Food & Drug Administration (“FDA”) as the preferred standard for electronic study submissions, is expected to revolutionise the process for both pharmaceutical companies and regulators. Currently, FDA reviewers receive paper or electronic paper submissions, which require time-consuming manual data input. The SEND format enables electronic submissions of nonclinical data, thereby improving efficiency as well as data quality, accessibility and predictability.
Instem has been an industry leader in SEND since 2004, and has been an active contributing member to several committees dedicated to advancing and promoting the standard alongside the US Food & Drug Administration (FDA). The Group’s leading position in this developing area was underlined in February 2012, when Instem was recognised for its outstanding contributions to SEND at the Interchange North America event organised by CDISC, the Clinical Data Interchange Standards Consortium.
This order is one of a number of contracts currently under negotiation which have a possibility of closure before the year end. Some of these are required to meet revenue and profit expectations for the year. Instem expects to update on trading prior to closing the financial year ending 31 December 2012.
Phil Reason, CEO of Instem plc, commented: “I am delighted to announce this contract with one of the largest international biopharmaceutical companies for our innovative Centrus suite. This customer is at the forefront of developing SEND for regulatory submission as well as facilitating the aggregation of internally and externally generated study data to improve early development productivity. Given our central position in the development of the SEND standard and our established global Provantis customer base, we believe future opportunities for Centrus to be significant.”
For further information, please contact:
|Phil Reason, CEO||+44 (0) 1785 825600|
|Nigel Goldsmith, CFO|
|N+1 Singer (Nominated Adviser & Broker)||+44 (0) 20 7496 3000|
|Wallbrook Financial PR||Tel: +44 (0) 20 7933 8000|
|Paul Cornelius||or firstname.lastname@example.org|
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 rapidlyexpanding needs of life science and healthcare organisations 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 450 clients through full service offices in the United States, United Kingdom and China with additional locations in Japan and India.
To learn more about Instem solutions and its mission, please visit instem.com.