Supporting every stage of the product development life-cycle.
Our services
From clinical trial development including data management and biostatistics, and gaining final regulatory approval, Accelagen offers cost-effective and clear pathways to market that result in better patient outcomes and industry improvement.
Never wavering from our collaborative and patient-centred approach, we help guide organisations both big and small, and together co-create meaningful outcomes that have a tangible and measurable impact on the future of human health.
Strategic consultationIndustry-leading insights and access to world-renowned experts.
We offer strategic consultation and resourcing that help take your important therapeutic assets from preclinical stages through to Phase IV clinical trials, regulatory approval and final market authorisation. By understanding your company’s development pipeline, we quickly assess the tasks needed to achieve your objectives and provide you with a streamlined pathway to help bridge the gap from where you are now through to the desired outcome.
Our strategic process is about the question you’re asking that makes the difference, not the answer.
Offering strategic direction and consultation no matter where you are on the product life-cycle, we bring an intentional focus to align your goals and objectives with the broader impact you hope to have. We approach this differently, and we work with you to understand what is the specific question you’re hoping to answer. Through this initial evaluation, we arrive at the desired outcome and from there, our experienced team can help you navigate and understand the short and long term challenges that often hold projects back and together, we can chart a course for success right from the start.
Clinical trial managementDecades of experience delivering reliable and innovative results.
As a locally positioned and globally adept CRO, we can offer full study delivery from initiation to activation, and execution and completion. Our highly skilled team can provide expertise in clinical trial management, medical writing, biostatistics and data management. With a combined 160+ years of experience in drug and medical device development, we have experience in many different types of clinical trial design, including: Randomised Controlled; Parallel Group; Crossover; Adaptive; Retrospective; and Prospective.
Providing the highest quality management of preclinical and Phase I–IV trials in accordance with International Guidelines and the highest regulatory requirements, we can customise our operations for large multinational clinical trials through to smaller single site trials for specialised therapeutics. Each project will have a dedicated and experienced Project Manager who will track and report on progress, timelines and milestones to give you maximum transparency and peace of mind. Our Project Managers act as a central point of communication between sponsors, and Investigators, with the primary ambition to facilitate the development and implementation of a successful study that leads to regulatory approval and safe and effective treatments for patients.
Regulatory affairsCharting the most cost-effective path for success.
Gaining regulatory approval for a new product is a significant undertaking, and it may only be the beginning of the process. Having successfully submitted and achieved approvals in both Australia and internationally, our experienced team provides cost-effective and clear pathways that maximise the likelihood of regulatory approval from the start. With your strategic objectives in mind, our team draws on extensive experience and existing data to chart a regulatory pathway. With key milestones identified along the way, we can advise on potential gaps in the regulatory information and the types of data required, including input into the optimal study design. We also offer industry-leading guidance on key strategic decisions that need to be made throughout the product lifecycle to help ensure the maximum outcomes for your new product.
Our expertise in regulatory submissions carries across several regions, including Asia-Pacific, North America and Europe, and covers the development of new data to support claims through to the modification of existing regulatory status and documentation.
BiometricsTranslating high-quality data into successful practice.
From database design and management to medical coding and protocol input, our highly experienced Biometrics team builds everything you need in-house. This means we can verify the quality, integrity and reliability of the data, tailored entirely to your needs. Our approach is entirely bespoke and designed to be as flexible as possible, so that you have more than a ‘one size fits all’ solution and are better able to achieve your strategic goals.
Adopting global CDISC standards and user-friendly systems, our state of the art technology offers you industry-leading insights and creates a ‘shared language’ for CRAs, data managers and regulators alike.
This shared language is designed to clear the way for more meaningful and efficient research and enables us to have a greater positive impact on global health. We are passionate about challenging the status quo and finding real world applications for research and data, which is why we are passionate about partnering with organisations ready and willing to use research to collectively solve some of the world’s most pressing health and wellness issues.