Email: contact@prodatainsight.com
Our Services
We can provide full statistical support for your trial.
Biostatistical Consulting
Our biostatistics team have a strong focus on accuracy and clarity, whilst still offering a tailored, collaborative service that meets deadlines, allowing our clients to keep timelines and costs to a minimum. Our statisticians provide statistical consultancy support and have expertise across the full range of statistical activities needed to progress a product through the drug development process and post marketing (during lifecycle management).
Study Design
Statistical input to protocols, including design, choice of estimands, sample size, randomisation and preparation of the statistical analysis plan (SAP). We have experience within all phases of pharmaceutical clinical development, including late phase observational trials, and trials based on real world data / registry data. Further, we have experience with planning of explorative and pivotal trials within the medical device and diagnostic tests area.
Study Reporting
Statistical analyses in accordance with the SAP, including interim analyses and pharmacokinetic analyses. We also conduct explorative post-hoc analyses. We provide input to and review of the clinical trial report
Submission Support
Planning, preparation and review of the integrated summary of safety (ISS), the integrated summary of efficacy (ISE), and the clinical pharmacology summary. Assistance during the question and answer period.
Post Marketing and Lifecycle Management Activities
For example, meta-analyses, indirect comparisons, sub-group analyses, analyses of real-world data
Additional Statistical Support
Such as independent quality control of statistical activities, statistical due diligence (e.g. in-licencing of drugs), journal manuscript input and review, and advice on processes.
Partner with PDI and embark on a transformative journey towards data-driven excellence.