Statistics

Statistical thinking is key to ensuring that clinical development plans appropriately address their objectives, and that the information acquired through the course of development is utilised in the most efficient way. At the same time, it is important to keep an eye on key regulatory requirements.

What we offer

From inception to reporting, our expert statisticians will ensure that your study is designed to meet your clinical objectives
Review and exploratory analysis of historic data, either for hypothesis generation, or to form the basis for planning future trials
Recommendations on the most appropriate study design (eg. parallel group versus cross-over or adaptive design)
Provide support and representation at health authority meetings
Choice of control group: superiority versus non-inferiority
Sample size justification
Simulations used to investigate complex problems, presenting statistical issues in an accessible way
Input into clinical study protocol
PK / PD parameter derivation and analysis
Extensive experience of preparing detailed and accurate statistical analysis plans (SAPs) for most therapeutic areas and study phases to allow for successful analysis and reporting activities
SAPs developed well in advance of key deliverables to allow for early programming and the fast, reliable delivery of results
SAS® programs written to implement the analysis and reporting requirements as specified in the SAP
CDISC standards applied in CRF design and data management flow through into statistics, ie. ADaM and define.xml
Statisticians involved and advising clinical, data management and medical reporting from day one
Rigorous peer review procedures to ensure quality delivery
Expert statistical reports and publications
Preparation of electronic submission-ready data sets
Support for ISS / ISE
Experience of data integration from multiple trials and creation of standards-based data repositories and support meta-analysis, eg. as part of the partnering due diligence process