|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 northern hemisphere.”
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 and abroad.”
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 regulators
- 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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