Brisbane, Australia and London, UK- 1 December 2011- Clinical Network Services (CNS), an Australian full service CRO specialising in the planning and management of Phase I & II clinical trials, today announced the launch of its new BioDesk regulatory service at the Genesis conference in London. Mark Reid has been appointed to head up this new preclinical and regulatory planning consultancy positioned to take biotechnology companies efficiently through preclinical and regulatory stages, allowing for earlier entry into human safety & proof-of-concept clinical trials and beyond.
BioDesk has assembled an international, multi-disciplinary network of preclinical and regulatory consultants and will draw from these to select the ideal team, optimised for each project. BioDesk’s experts can also engage with clients at the earliest of stages of product profiling, market positioning and support for investor due diligence.
Mark Reid, who will head up the consultancy, has a track record as an Investigator and as a Senior Regulatory Affairs Manager in Europe and Australia, advising clients in preclinical and clinical planning for their Biologicals and NCEs. Mark is a recognised expert in the regulatory environments around the world for gene therapy and genetically modified organisms (GMOs), giving BioDesk a particular advantage.
Russell Neal, COO of Clinical Network Services commented:
“Through BioDesk we are offering the worldwide biotech industry a focused approach to biotherapeutic development. When coupled with our Fast2First clinical trials services, this approach drives efficient navigation of 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.”
Specifically the services offered by BioDesk include:
- Developing a forward looking Target Product Profile (TPP);
- Supporting the development of investigational product and preclinical data to support entry to the clinic;
- 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. and
- Project and programme management.
CNS will be participating at the OneNucleus Genesis conference in London on December 1st and will be happy to meet with anyone interested in discussing BioDesk or Fast2First.
About Clinical Network Services
Clinical Network Services (CNS) Pty Ltd is an established, niche Clinical Research Organisation (CRO) specialising in the management of Phase I & II clinical trials in Australia and New Zealand for SME Biotech. Australia has the outstanding advantage of a pragmatic regulatory environment that makes it possible to enter the clinic quickly, without the need for prior approval from another regulatory agency, and add value to the global regulatory dossier.
CNS focuses on serving the needs of its local and international SME Biotech clients and understands that our clients and their investors need to develop novel therapeutics in a cost and time-efficient manner.
CNS has a longstanding track record in the conduct of early stage trials for its predominantly US/European client base and prides itself on its demonstrable responsiveness and customer focused approach.
CNS works in partnership with its clients to provide Phase I and II clinical trial services under the “Fast2First” brand, which includes: protocol development, study start up, monitoring, study management, data management/biostatistics and clinical study report writing services.
CNS has further developed its partnership approach to provide upstream pre-clinical/clinical plan development and management through “BioDesk”. “BioDesk” is an advisory service dedicated to shortening lead-in times for our Australian and international clients preparing to enter the clinic.
Further information on CNS can be found at www.clinical.net.au
Clinical Network Services
T: +61 (0)7 3719 6000
College Hill Life Sciences
Dr. Douglas Pretsell/ Gemma Howe
T: +44 (0)20 7866 7860