INS.L Regulatory News (INS)

Instem plc

("Instem", the "Company" or the "Group")

SEND outsourced services contract win

Top five global nonclinical CRO outsources all SEND data set generation to Instem

Instem plc (AIM: INS), a leading provider of IT solutions to the global life sciences market, is pleased to announce the award of a new two-year SEND ("Standard for the Exchange of Nonclinical Data") outsourced services contract by a top five global nonclinical contract research organisation ("CRO"), worth in excess of £1.7million over an initial two year period. Instem's expert SEND services team will use its proprietary SaaS-based submit™ technology platform throughout the engagement to create and review all of the CRO's SEND data packages.

The dedicated Instem team allocated to this CRO is expected to grow to around 15 people by the end of the first year of the contract as additional staff are recruited and trained. The team will transition from being predominantly UK/US based to predominantly India based over a 15-month period. Study volume is scheduled to ramp up through the contract period with revenue of at least £0.7m expected to be generated in 2018.

SEND submit™

Instem has been engaged in the development of SEND since 2004, recognising that the development of such a standard would be an important and transformational event for the industry. The US Food & Drug Administration ("FDA") mandated SEND for certain study types in December 2016 and a significant increase in industry SEND volume is now occurring following a second milestone in December 2017 for studies supporting the earlier stages of regulatory drug submission. The implementation of SEND is now a market imperative for the entire drug development industry.

Instem has assembled an experienced group of SEND experts, including several staff members that maintain leadership positions on the industry committees that both oversee the Standard and provide guidelines for its exploitation.

Instem's SEND services team produces and verifies SEND packages for clients across the globe with multiple requests currently being received from the USA, Japan, India and Europe. One of the unique strengths of Instem's SEND services team is its ability to blend its market-leading technology platform with an unrivalled professional services team, ensuring delivery of high quality output in competitive timescales. The Company pays close attention to both the regulatory and information security considerations of handling and processing precious customer data to ensure it minimises risk and time spent on quality control activities.

All study conversions are performed on a secure, hosted and validated SEND services platform, which is available and supported 24/7 utilising Instem's submit™ SEND software suite. This is the same submit™ software that is in production use at pharma and contract research organisations worldwide.

Phil Reason, CEO of Instem plc, commented: "Winning what we believe to be the largest outsourced SEND services contract ever awarded is clearly a huge endorsement of Instem and our SEND credentials.

"For several years, we have been presenting an anticipated substantial 2018 uplift in SEND study volume following the December 2017 FDA mandate, which is now materialising. With SEND data sets now on the critical path in the new drug development timeline, the industry will only work with partners that can quickly deliver to an exceptionally high quality, which puts Instem's people and technology in very high demand. This new CRO award, combined with commitments to other clients, means we are already contracted to deliver in 2018 over five times the number of SEND assignments completed in 2017."

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About Instem

Instem is a leading provider of IT solutions & services to the life sciences market delivering compelling solutions for Study Management and Data Collection; Regulatory Solutions for Submissions and Compliance; and Informatics-based Insight Generation.

Instem solutions are in use by customers worldwide and enable our clients to bring life enhancing products to market faster.

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 harmonisation of actionable scientific information.

Instem supports over 500 clients through offices in the United States, United Kingdom, France, Japan, China and India.

To learn more about Instem solutions and its mission, please visit instem.com.