The following organisations can provide strategic advice on the conduct of COVID-19 vaccine clinical trials in Australia:
Biointelect is a strategic planning and commercialisation consultancy operating in the biopharmaceutical and medical device sector. They specialise in the entire drug development process, from early pre-clinical work right through to the in-market phase, and work with a range of clients including research institutions, commercial companies, government and not-for-profit organisations. They provide an extensive service offering to those seeking to commercialise new technologies in both Australia and global markets – including strategic clinical and regulatory support, market evaluation and market entry/reimbursement strategy. Biointelect have deep global experience in vaccines including preclinical R&D, supporting phase I-III clinical trials, development of international regulatory strategy as well as assisting with market access strategy and generation of evidence needed to support policy and funding in public and private markets.
Biointelect are well placed to assist those conducting clinical trials in Australia and can provide support in navigating the Australian tax regulatory and legal system, coordinating and project managing service providers and key stakeholders, developing commercial rationale to support the project, providing input into corporate strategy and business plans and conducting interviews and site visits with selected phase 1 units to document capabilities and identify and recommend relevant trial sites. With and an extensive network and broad depth of global experience, as well as a proven track record in new product launches, Biointelect is a strong partner when it comes to helping clients reach their commercial goals.
Accelagen is an Australian and New Zealand based Contract Development Organisation, dedicated in the field of regulatory affairs and clinical research. Accelagen provides strategic guidance and support throughout all stages of product development, including the development, initiation and management of vaccine clinical trials including:
- Study protocol design and preparation
- Site feasibility assessment and qualification
- Project and site management
- Monitoring and query resolution
- Safety management and oversight
- Clinical Study Report preparation
The team at Accelagen have extensive expertise in all aspects of vaccine development, including manufacturing and quality, clinical development and product registration. Our regulatory team can provide strategic guidance for the development and execution of regulatory strategies, intended to successfully gain marketing approval for therapeutic goods in key markets around the world, and through our well established network, can facilitate the effective interaction with Regulatory Agencies in key jurisdictions, including Australia, Europe and the United States.
360biolabs is Australia’s most comprehensive specialty laboratory for therapeutic, vaccine and diagnostic development. We develop and conduct pharmacokinetic (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas in a quality assured environment (OECD GLP, ISO 17015 & ISO 15189) and provide extensive support services to ensure the success of clinical trials.
360biolabs has the capability to support bioanalysis for new and established small molecules, peptides, proteins and large molecules. Our industry experienced chemistry and biology teams enjoy the challenges of developing, validating and conducting sensitive quantitative determinations from a variety of biological matrices as well as metabolite identiﬁcation and other complex analytical requests. Our immunology experts oﬀer a suite of assays for complex biologics, extensive immune monitoring and biomarker analysis and the ﬂexibility to development and validate new drug-specific assays.
Our classically trained virology team, particularly experienced in respiratory virus research, add to the breadth of 360biolabs capabilities. The virology team has a wealth of industry experience; our scientists have worked with most virus families known to science and supported many clinical trials and regulatory submissions. In the molecular age, it can be challenging to ﬁnd a team with cell culture-based virology expertise and when we combine our virology, immunology and molecular biology teams, 360biolabs can support any end point required for vaccine or antiviral discovery and development.