Translating data into real world findings that put people first.
About Biostatistics
Accelagen’s global reputation, coupled with explosive demand for local CROs to service Australia’s growing clinical trial market, has recently allowed us to bring all biostatistics and data management capabilities in-house. This means sponsors now have access to a full clinical trial service; delivering high-quality biometrics services that are both patient and regulatory-focused. This also means we have significantly enhanced the quality and integrity of our data and our methods minimise any gaps and ensure a streamlined, end to end process to record, analyse and report on trial data comprehensively, while focussing on the key outcomes needed, in a regulatory compliant way. Our highly experienced team of biostatisticians has a broad range of experience across Phase I-IV trials, and widely varied expertise across the health, wellness and disease spectrum.
In more detail
Initiation Phase
By bringing Data Management and Biostatistics under one roof, Accelagen can now align input and analyse data efficiently and support timelines for study startup, quicker than ever before.
Study design
Supporting the process of study design from a statistical perspective, including, but not limited to: the defining of objectives and endpoints /estimands, sample size estimation, and developing a robust statistical analysis plan, to ensure a statistically robust design.
Clinical trial protocols
Developing the clinical trial protocol, or investigative plan, with consideration given to all applicable regulations and guidelines, including the ICH E9 addendum around estimands and missing data.
End-to-end services
Providing end-to-end data management services for Phase I–IV and other post-marketing commitments
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Activation Phase
Considered to be the ‘gold standard’ of clinical trials, randomisation allows trial staff to make unbiased and informed decisions about new treatments, and more acutely evaluate the efficacy of a new treatment or intervention.
Randomisation
Offering paper-based randomisation with sealed envelopes, as well as IWRS randomisation methodologies, including stratified and dynamic randomisation.
Options for design
Offering different types of clinical trial design, Accelagen can manage Randomised Controlled; Parallel Group; Crossover; Adaptive; Retrospective; and Prospective, among others.
ePRO and data capture
We offer ePRO to capture data directly from study participants as well as third party data transfer specification and management
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Execution Phase
In this phase, the lead statistician maintains ongoing statistical oversight throughout the study.
SAPs, SRC and DSMB
Preparation of clear and detailed Statistical Analysis Plans (SAPs), SRC and DSMB analyses, including mock output shells.
Compliance and safety reports
Regulatory safety reports prepared in accordance with ICH E9 and other applicable guidelines, for clinical study reports, interim analyses and data monitoring committees.
Reconciliation and estimation
Where needed, we can develop customised reports, third party data reconciliations and sample size re-estimations.
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Completion Phase
Collaborating closely with our experienced team of medical writers, we can support the presentation and reporting of your study’s statistical outputs to ensure the statistical accuracy of any conclusions drawn.
Highly customisable
We can customise your reporting to deliver a high-quality, cost-effective solution in line with the most rigorous regulatory standards.
Scalable and standardised
By adhering to global standards, Accelagen helps to boost the value of your study investment by making data accessible, interoperable, and reusable.
Final quality checks
Completing any final format verifications, validity confirmations, data comparisons, and spot checking.
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