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Clinical Network Services (CNS) Opens New UK Office and Expands Core Services
|By Business Wire
|March 10, 2014 05:04 AM EDT
Clinical Network Services (CNS) an integrated product development
company based in Australia and New Zealand providing broad services in
the planning, implementation and delivery of preclinical, Phase 1 and 2
trials, today announced that it has launched a new office near London
headed by Paul Cronin who joins as UK Director and Director, Business
Development. The new UK office is primarily a BioDesk initiative and CNS
will continue to undertake its core business of conducting early phase
clinical trials in Australian & New Zealand given the simplicity of
regulatory review and time advantages for this region.
At the same time the Company has launched a new Biometrics service and
has appointed Otto Damsma as Director of Biometrics and Glynn Morrish as
Pharmacometrician/Biostatistician at its Brisbane headquarters.
CNS welcome Paul Cronin who, having worked for highly regarded European
regulatory consultancy companies, is very experienced in regulatory
affairs and product development, in particular with complex biologics.
As well as driving global Business Development for CNS, Paul will lead
the European BioDesk team in support of CNS clients requiring access to
the European regulatory agencies as well as European clients seeking
entry to Australia and New Zealand. The location of the European office
is of key importance with regards to European regulatory activities as
it allows for easy access to the European Medicines Agency (EMA) and the
UK MHRA both of which are based in London.
Otto Damsma led Biometrics and IT at Yamanouchi/Astellas in Europe for
more than a decade while Glynn Morrish is a leading Australian
Pharmacometrician and Biostatistician. Together they form a strong
Biometrics team providing an optimised customer centric service making
use of a globally recognised suite of electronic data capture solutions
and data analysis tools.
Mark Reid, Director, BioDesk and Regulatory Affairs, commented:
“It really is superb having Paul, Otto and Glynn join CNS. These
appointments have further expanded BioDesk’s ability to engage European
regulators and to bring expert statistical and PK/PD modelling
capabilities to early stage product development. I’m very pleased with
the early impact these appointments have had as BioDesk continues to
solve complex product development problems for our clients.”
Paul Cronin, new UK Director and Director, Business Development added:
“I’m really pleased to be joining such a dynamic team and look forward
to working closely with Mark and the Australian and UK operational teams
to develop the CNS business across Europe and more generally the
Russell Neal, Managing Director of CNS concluded:
“By opening the UK office and making these three strategic hires; CNS is
fast becoming the leading Australian supplier of strategic product
development advice and early stage clinical development support to small
to medium sized biotechnology companies. Paul is widely regarded in
international and local industry circles and Otto and Glynn are both
considered experts in their fields, bringing a wealth of knowledge to
our team that will deliver an ongoing advantage of our clients at home
The address for the UK office is: Clinical network Services (UK)
Limited, Fountain Court, 2 Victoria Square, Victoria Street, St Albans,
AL1 3TF, UK. (Tel +44 (0)1727 884612)
- ends -
About Clinical Network Services
Clinical Network Services (CNS) Pty Ltd is an Australian, New Zealand
and UK CRO offering integrated development services to virtual, small
and medium sized Biotech companies in the planning, implementation and
delivery of Phase 1 and 2 trials, and beyond. CNS offers a unique
service where it integrates BioDesk, an intelligent product
development planning and regulatory affairs service, with our
committed, highly experienced regional clinical operations team. The CNS
“Regional Advantage” is driven by our extremely pragmatic regulatory
environment that makes it possible for our clients to enter the clinic
quickly, without the need for prior regulatory agency approval.
Specifically, BioDesk works closely with our clients to design,
implement and manage manufacturing and preclinical plans that are
mindful of commercial timelines and budgets, allowing swifter go/no go
decisions for our clients and their investors. With operations across
Australia and New Zealand, CNS makes use of its close relationships with
key opinion leaders, world leading clinical facilities, and globally
respected Phase I units across a wide variety of therapeutic
indications. Our service offerings include: product development,
regulatory affairs planning and development, clinical planning, study
start up, monitoring, project management, data management,
biostatistics, pharmacometrics, medical consultancy/monitoring, medical
writing, bioanalytical services and safety reporting.
Further information on CNS can be found at www.clinical.net.au
Notes for editors
BioDesk is a unique global product development and regulatory planning
consultancy which assists Biotech companies get into the clinic faster
through creating and managing a manufacturing and pre-clinical programme
that encompasses a globalised regulatory perspective whilst leveraging
unique regional advantages.
Specifically, BioDesk works closely with our clients to design,
implement and manage manufacturing and pre-clinical plans mindful of
commercial timelines and budgets, allowing swifter go/no go decisions
for our clients and their investors.
Services offered by BioDesk include:
Developing a forward looking Product (Drug) Development Plan
Supporting the aggregation of pre-clinical chemistry, GMP and CMC
Formulating development plans appropriate to venture capitalists and
Strategic regulatory advice for key international and local markets
Support and development of regulatory submissions such as INDs, CTAs,
BLAs, MLAs, etc.
Project and programme management.
Through BioDesk, CNS offers the Biotech industry a focused approach to
biotherapeutic development. When coupled with our clinical management
expertise, our approach drives efficient navigation through the critical
period of post-discovery planning and initial clinic testing whilst
adding value to the global dossier and delivering improved commercial
outcomes to our clients.
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