Execution of the most appropriate statistical methods and the correct presentation and interpretation of study results is key to the success of any clinical study. Services we offer include:
Expanding on the statistical methods outlined in the protocol, the Statistical Analysis Plan (SAP) is a key study document. Full specification of statistical models and templates of tables, figures and listings are provided. We can prepare a SAP using our own template, or populate the template provided by you, the client.
We develop SAS programs to turn the raw data into a full set of tables, figures and data listings that can be integrated into the clinical study report. The level of validation can be tailored to meet your needs. At the end of the study, we supply you with the SAS programs, logs, outputs and datasets.
The clinical study report is the final piece in the jigsaw of any clinical study. Statistical input into the report writing process will ensure that the results are interpreted and communicated correctly. Depending on your needs, PCS can assist with the writing of the report, or just perform a review.
When it comes to submitting clinical study results for publication in a manuscript, additional analyses are often required. PCS can help with performing these analyses, as well as with the writing and/or reviewing of publications.
Expert statistical input into the protocol to ensure your study is appropriately designed to answer the objectives.
Development of a suite of SAS programs to generate report ready tables, figures and data listings.
Utilisation of historical data and relevant publications to provide sample size estimates.
Preparation of a statistical analysis plan, and usage of the most appropriate statistical methods to leverage your study data.
Preparation of randomisation schedules.
Statistical input into the clinical study report and analyses for publications.