Our Biometrics staff have expertise across the full range of statistical activities needed to progress a product through the drug development process. We have extensive experience of working with small early-stage biotech companies as well as large international pharmaceutical organisations.
At S-cubed we have a strong focus on accuracy and clarity, whilst still offering a tailored, collaborative service with a quick turnaround, allowing our clients to keep reporting timelines and costs to a minimum.
Providing a comprehensive statistical service, we are experienced in attending regulatory agency meetings throughout the world and have overseen many successful client and regulatory audits.
Study Design – Statistical input for study design and protocols, clinical development plans, sample sizing, randomisation and statistical analysis plans
Study Reporting – TFL production, interim analysis, pharmacokinetic analysis and statistical report writing
Post-hoc Analysis – Provision of post-hoc and/or exploratory ad-hoc clinical trial analysis and advice
Submission Preparation – ISS, ISE and CDISC integrated datasets for electronic submissions (eCTD)
DSMB – Participation as an independent statistician on DSMBs, including preparation of charters and analyses
Regulatory Meetings – Preparation and attendance at agency meetings
Statistical Support – Wide range of additional services, such as Biometrics project management, independent quality control of statistical activities, statistical due diligence (e.g. in-licencing of drugs), journal manuscript input and review, and advice on processes and audits