|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.
As pervasive as cloud technology is -- and as persuasive as the arguments are for using it -- the cloud has its limits. Some companies will always have security concerns about storing data in the cloud and certain high-transaction applications will always be better suited for on-premises storage. Those statements were among the bottom-line takeaways delivered at Cloud Expo this week, a three day, bi-annual event focused on cloud technologies, adoption and associated challenges.
Apr. 23, 2017 08:15 AM EDT Reads: 3,584
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
Apr. 23, 2017 07:45 AM EDT Reads: 373
Multiple data types are pouring into IoT deployments. Data is coming in small packages as well as enormous files and data streams of many sizes. Widespread use of mobile devices adds to the total. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists will look at the tools and environments that are being put to use in IoT deployments, as well as the team skills a modern enterprise IT shop needs to keep things running, get a handle on all this data, and deli...
Apr. 23, 2017 07:45 AM EDT Reads: 1,738
Quickly find the root cause of complex database problems slowing down your applications. Up to 88% of all application performance issues are related to the database. DPA’s unique response time analysis shows you exactly what needs fixing - in four clicks or less. Optimize performance anywhere. Database Performance Analyzer monitors on-premises, on VMware®, and in the Cloud, including Amazon® AWS and Azure™ virtual machines.
Apr. 23, 2017 07:15 AM EDT Reads: 1,409
SYS-CON Events announced today that Grape Up will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct. 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Grape Up is a software company specializing in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market across the U.S. and Europe, Grape Up works with a variety of customers from emergi...
Apr. 23, 2017 07:00 AM EDT Reads: 1,420
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Apr. 23, 2017 04:45 AM EDT Reads: 2,716
Translating agile methodology into real-world best practices within the modern software factory has driven widespread DevOps adoption, yet much work remains to expand workflows and tooling across the enterprise. As models evolve from pockets of experimentation into wholescale organizational reinvention, practitioners find themselves challenged to incorporate the culture and architecture necessary to support DevOps at scale. In his session at @DevOpsSummit at 20th Cloud Expo, Anand Akela, Senior...
Apr. 23, 2017 04:15 AM EDT Reads: 1,321
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in compute, storage and networking technologies, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/...
Apr. 23, 2017 04:00 AM EDT Reads: 1,635
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Apr. 23, 2017 03:45 AM EDT Reads: 242
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...
Apr. 23, 2017 03:45 AM EDT Reads: 4,513
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
Apr. 23, 2017 03:30 AM EDT Reads: 271
Judith Hurwitz is president and CEO of Hurwitz & Associates, a Needham, Mass., research and consulting firm focused on emerging technology, including big data, cognitive computing and governance. She is co-author of the book Cognitive Computing and Big Data Analytics, published in 2015. Her Cloud Expo session, "What Is the Business Imperative for Cognitive Computing?" is scheduled for Wednesday, June 8, at 8:40 a.m. In it, she puts cognitive computing into perspective with its value to the busin...
Apr. 23, 2017 03:15 AM EDT Reads: 3,399
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
Apr. 23, 2017 02:45 AM EDT Reads: 1,612
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across supply chain networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost and time for product recall as well as advance trade. Are you curious about Blockchain and how it can provide you with new opportunities for innovation and growth? In her session at 20th Cloud Exp...
Apr. 23, 2017 02:45 AM EDT Reads: 1,192
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Apr. 23, 2017 01:45 AM EDT Reads: 8,595