Biostatistics

Innovative clinical trial designs that take advantage of our in depth statistical expertise

We work across all phases of drug development and all therapeutic areas. Our experts are industry leaders who have extensive knowledge of experimental design, statistical methodology and global regulatory requirements to help design your trial for better decision making.

1000
Clinical trials
190+
Adaptive design trials
230+
Independent DMC

Our wide range of support options provide economical solutions that positively impact your development pipeline. We are industry experts and know the value of utilising standard validated processes, along with an extensive quality control program ensuring accurate and timely deliveries.

Our experts are committed to anticipating and overcoming challenges you are facing. We offer consulting, standalone, or full service integrated solutions geared toward your success.

Bringing clarity and focus to the research question: the role of estimands

Services

Full range of biostatistics services.

Statistical consulting

We can tailor support to meet your needs and provide valuable insight and feedback.

Data integration and standardisation

We convert your data using the approved CDISC: SDTM and ADaM standardised formats. This provides consistency from study to study which ultimately supports and accelerates your regulatory submission.

Adaptive and Bayesian designs

Our statisticians have expertise dealing with sample size re-estimation, changing hypotheses, and combining Phase II/III trials. Learn more about Adaptive and Bayesian designs.

Independent data monitoring committee

Our industry recognised statisticians will advise and support you throughout the entire DMC process. We can guide sponsors in: subject safety, potential risks, identifying indicators that warrant the trial to stop early due to futility or efficacy, sample size changes, and dropping treatment arms in multi-armed trials.

Medical Device trials

We have experts that specialise in medical device trials and have adopted adaptive design for the development of a medical devices which offers a number of valuable benefits. These include improved device development efficiency, increased odds of pivotal trial success, shorter time-to-market, and improved decision-making.

Regulatory submission support

When you're seeking approval for your compound, let our experienced staff guide you through the complicated regulatory requirements. We have supported regulatory submissions for compounds across all major therapeutic areas. We understand the pitfalls and how to avoid them, thus providing costs savings, and ultimately accelerating time to approval.

Experience you can trust

Our team consists of over 300 professionals, located across the globe, with the largest concentrations in the US, EU and Asia Pacific. Our experts have an average of 10 years' statistical industry expertise.

60% of staff have advanced degrees (Masters, PhD), with extensive knowledge of experimental deign, statistical methodology, and global regulatory requirements. We provide guidance on all aspects of the design, sizing and conduct of a trial to ensure analysis methods fully conform to the latest regulatory standards and guidelines.

Our staff are all trained in delivering CDISC SDTM and ADaM compliant data structures. Our experience includes more than 460 trials converted to SDTM and 255 trials utilizing ADaM. These were all successfully delivered and met all regulatory requirements.