Novotech is the largest independent CRO in Australia. With operations in the US, Novotech is ideally positioned to offer clinical research services on the ground in both the US and Australia/New Zealand. There is an increasingly greater demand for CROs to offer services across these two regions providing the benefits of Australia’s highly regarded cost-effective clinical trial capabilities, and at the same time take advantage of access to the much larger US market for rapid patient enrolment.

Our comprehensive range of services extend the full spectrum of clinical drug development services to the global pharmaceutical and biotechnology industries. Our Australian Head Office is situated in Sydney, with regional offices in Melbourne and Brisbane providing easy access to the most important population centres in Australia. Supported by regional staff in Perth and New Zealand, our coverage of the Australia/New Zealand region is second to none.

Our US headquarters are situated in Carlsbad, California, just north of San Diego. We provide national coverage in the United States supported by regional staff based on both coasts and key regional locations.

Our company philosophy is focussed on hiring experienced professionals with local environment expertise. Both in Australia and the US, the company boasts some of the most experienced Project Managers and CRAs in the industry. Our vision is to be recognised as the CRO of choice by all our clients in Australasia and the US, something that we are well on the way to achieving.

In addition, through key external partnerships and strategic alliances we offer worldwide reach to our clients, including Canada, Europe, Latin America and Asia. This combination of a small, flexible CRO, coupled with the ability to confidently manage very large projects allows us to move a project from initial planning stage to recruitment with dramatic speed.

Novotech is one of the few organizations in the CRO industry with accreditation by the International Standards Organization (ISO) - compliant to internationally recognized standard ISO9001:2000. Novotech is regularly audited not only by clients, but external quality endorsement organisations as part of maintaining ISO credentials.

What this means for our clients is that you can expect at a minimum, a structured, professional approach to all aspects of the management of your project. This approach ranges from administrative requirements, contract and operational issues through to reporting and communication needs.

Study Management
Study Management services in Australia, North America and Europe include all elements of project development from the earliest steps to completion of a trial and beyond. Some of the core components of our study management services are:

• Protocol development
• Investigator brochure write-up
• CRF design
• Site selection
• Site initiation, interim monitoring and close-out
• Data management
• Statistical services
• Report write-up to ICH requirements
• Post marketing surveillance
• Technical writing

Site Selection
Appropriate site selection is one of the cornerstones of a successful project. That is why we conduct detailed feasibility assessments of projects we undertake. Feasibility includes careful site selection and assessment. Our personnel visit all sites and prepare reports prior to inclusion in a trial. The study objectives are discussed in detail with potential investigators before site recruitment. Sites must conduct their activities to GCP guidelines and have the ability to recruit adequate patients to meet protocol objectives and project timelines.

Wherever possible, we also retain a list of backup sites in case these are needed after the trial has been initiated. Not only does this assist with rapid expansion of a study if necessary, but if any sites drop out, these can be replaced with a minimum of delay.

Monitoring
All Novotech monitors with site responsibility have at least two years industry experience, and in many cases, more. Routine co-monitoring of sites by Project Managers is a common feature of our approach to trial management. This ensures that our Project Managers see first hand, specific issues facing a trial and they receive feedback from site staff and CRAs as any issues arise. The commitment shown to sites in this way is usually returned in kind, helping make the entire research process fruitful and rewarding for all concerned.

At Novotech, we have a regulatory group dedicated to managing the IRB approval and regulatory process to ensure efficient and timely start-up of all studies. Our prior experience in this area covers nearly all major institutions in the country, as well as the SCOTT process in New Zealand.

As one of the few CROs in Australia with a dedicated regulatory group, we can take on individual projects where our brief may be confined just to managing the IRB and regulatory process, with the client taking responsibility for its own project management and monitoring tasks.

Our primary goal in data management is to provide clean, locked databases, in a suitable format, on time and to budget.

To achieve this, we use a variety of tools including the highend industry standard -Clintrial^® to validated eCRF technology. The path taken depends upon your needs, site practicalities as well as our capabilities. Whilst we work through these in consultation with you, we never forget our primary goal outlined above.

Whether your data originates in Australia/New Zealand, or the US, our data management service can be tailored to provide a high quality cost effective solution compliant with the most rigorous regulatory standards.

Therapeutic areas in which our staff have experience include the following:

• Analgesia - pain management
• Anti-infectives - novel antibiotics, vaccines, monoclonal antibodies
• Cardiovascular - CHF, chronic angina, ACS (acute coronary syndromes), CAD, stroke
• CNS - epilepsy, Alzheimer's, MS, depression, ADHD, migraine, sleep disorder
• Dermatology - actinic keratosis, basal cell carcinoma
• Endocrinology - diabetes, HRT, obesity, osteoporosis
• Haematology - DVT, leukaemia, lymphoma, myeloma
• Infectious Diseases - sepsis, genital herpes
• Gastrointestinal - IBD, haemorrhoids, Crohn's disease
• Oncology - a range of indications including: NSCLC, colorectal, melanoma, hepatic, ovarian, pancreatic, head & neck, breast, prostate, glioma
• Ophthalmology - glaucoma, macular degeneration
• Respiratory & Allergy - asthma, rhinitis, bronchitis, emphysema, pneumonia
• Rheumatology

We also have experience in studies involving the following devices:

• Cardiovascular
• Respiratory

Going back to its regulatory affairs origins, Novotech has a long history of managing standard and complex bioequivalence studies on behalf of local and international generic pharmaceutical companies. Using Novotech’s internal resources and network of independent vendors as required, we are able to bring you best-in-class services tailored for compliance with international regulatory standards at optimal pricing levels. We will typically achieve cost savings in the order of 30-40% lower than doing the same bioequivalence studies in many other parts of the world.

Projects are managed in full compliance with international regulatory standards. Through our in-house expertise in all facets of pharmacokinetic analysis, using a validated WinNonlin® platform, bioequivalence studies are analysed and reported typically within a two week turnaround time from availability of all plasma or urine assay data.

Novotech’s end-to-end generic bioequivalence service involves all steps of the process from protocol design to project management and conduct of study ending with pharmacokinetic and statistical analysis and report write-up.

As well as being an integral part of our internal processes, Novotech is able to provide a full range of independent Quality Assurance services from pre-clinical, through phase I to phase IV studies on an international basis. Our QA department is staffed by experienced professionals operating independently from the personnel engaged in the management and conduct of clinical trials.

Quality Assurance audits encompass all aspects of the clinical development process, including:

• Trial Master File Audits
• Investigator Site Audits
• Phase I Units
• Clinical Research Organisations
• Other vendors (e.g. archive facilities, Investigational Product management and storage)
• Study Documentation e.g. Protocols, Clinical Study Reports
• Systems Audits
• Computer System Validation Reviews
• Local, Central and Bio analytical Laboratories
• Database Audits
• GLP Audits
• Bio analytical Method Validation

In addition, Novotech is able to provide support and advice on the following:

• Quality System Management
• SOP Development
• Due Diligence

Our auditors have extensive auditing experience in various types of audits. Audits have been performed for a wide range of indications and in various countries e.g. USA, Canada, South America, Western, Central and Eastern Europe, India, Thailand, Australia and New Zealand.

Sydney, NSW Australia (Head Office)
Melbourne, VIC Australia
Brisbane, QLD Australia
Carlsbard, CA United States
Bridgewater, NJ United States

Contact Information

Novotech (Australia) Pty Limited
Julia Jones,
Director, Business Development
Level 3, 19 Harris Street
Pyrmont NSW 2009 Australia
Phone: +61 2 9518 9600
Fax: +61 2 9518 9390
E-mail:

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