Instem plc Contract Win
January 16 2018 - 2:01AM
RNS Non-Regulatory
TIDMINS
Instem plc
16 January 2018
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
GBP1.7million over an initial two year period. Instem's expert SEND
services team will use its proprietary SaaS-based submit(TM)
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 GBP0.7m expected to be generated in 2018.
SEND submit(TM)
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(TM) SEND software suite. This is the
same submit(TM) 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."
For further information, please contact:
Instem plc +44 (0) 1785 825 600
Phil Reason, CEO
Nigel Goldsmith, CFO
N+1 Singer (Nominated Adviser
& Broker) +44 (0) 20 7496 3000
Richard Lindley
James White
Rachel Hayes
Walbrook Financial PR +44 (0) 20 7933 8000
Paul Cornelius instem@walbrookpr.com
Helen Cresswell
Sam Allen
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.
This information is provided by RNS
The company news service from the London Stock Exchange
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