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Headquartered in Australia and focused exclusively on the Asia Pacific, Novotech is internationally recognized as a leading regional full-service CRO.
With the increasing pace of globalization in drug development, Novotech’s expertise in the vibrant and fast growing Asian region has been instrumental in the success of hundreds of phase I-IV clinical trials from Australia to India.
Headquartered in Sydney, with operations in New Zealand, China, Hong Kong, India, Malaysia, the Philippines, Singapore, South Korea, Taiwan and Thailand, Novotech’s service offering has come to be recognized for its quality both by our clients, as well as industry analyst groups.
Established in 1996, Novotech is Australia’s largest independent contract research organization (CRO). The Australian Head Office is situated in Sydney, with regional offices in Melbourne and Brisbane - providing easy access to the most important population centers in Australia. Supported by regional staff across the country and in New Zealand, our coverage of the Australia/New Zealand region is second to none.
With Asian services launched in 2007, Novotech’s operations provide access to the most dynamic and fast growing clinical research hubs in the region.
In addition, we offer worldwide reach to our clients through key external partnerships and strategic alliances, with partners in the US, Canada, Europe, and China.
The combination of a relatively small, flexible contract research organization (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.
Our People, Our Vision
Novotech’s key strength is our people. We’re committed to hiring experienced professionals with local environment expertise. Both in Australia and internationally, Novotech boasts some of the most experienced Project Managers and CRAs in the industry.
Our vision to be recognized as the Asia Pacific contract research organization (CRO) of choice, is a goal we get closer to reaching every day. In a recent Novotech survey of key decision makers at biopharmaceutical companies worldwide, all respondents who had partnered with Novotech before would recommend Novotech.
Novotech are committed to providing high quality clinical development services to all our clients. We are one of few organisations in the industry who have sought certification to an International Standard. Our corporate headquarters, where our quality system is managed, is certified to ISO 9001 Quality Management System standard.
What this means for our customers is that you can expect at a minimum, a high quality, structured, professional approach to all phases of your project management with us. Ranging from administrative requirements, contract and operational issues through to reporting and communication needs.
Some of the variables we continually assess during the life of a project are the following:
|Achievement of milestones within a project||Cost management - budgets versus actuals|
|Client communication level and quality||Timeliness of reporting|
|Cooperation level from sites||Training requirements of project team|
|Quality Endorsed Company|
As part of maintenance of our Quality Management System, Novotech conducts its own annual internal audits of all operational areas. We are externally audited annually for ISO 9001 re-certification and routinely audited on a regular basis by clients with whom we work. Every audit is a valuable learning and training exercise from which we take something away to improve our services for the future.
Advances in technology are what drive the pace of globalization in our industry. Access to critical project data in a timely and accurate fashion is often the difference between a highly successful project and an average one. Some of the technologies currently in use at Novotech that benefit our clients are:
Electronic Data Capture (EDC) – Medidata RAVE® is the flagship EDC solution at Novotech with several accredited study builders within our Biometrics department. With EDC, whether your site is in Bangalore, Sydney or New York, you get the same level of access to study progress at site level from the comfort of your own desktop.
Oracle Empirica Trace – Pharmacovigilance and safety management, whether in a clinical trial setting, or for marketed products, is not just a regulatory requirement, but a key component of R&D and product lifecycle management.
Clinical Trial Management System (CTMS) – Following adoption of Oracle Siebel CTMS in 2010, Novotech is now able to manage highly complex trials across any number of sites and countries with the same ease of reporting and management control as the smallest single site study. This also offers real-time web based reporting to clients anywhere in the world.
NetSuite Enterprise Resource Planning (ERP) – All Novotech associates and PMs are trained in Novotech’s cloud based ERP solution for optimal resource planning and utilization across projects. This enables greater efficiency across multinational projects and a high level of automation in service delivery.