Study Set-Up
Our biostatisticians take a flexible approach to your project, giving you the tailored support, you need. Our team can integrate fully with yours, supporting you with statistical tasks throughout the life of your clinical trial.
Protocol Review & Writing
Our input includes writing of statistical analysis sections, clinical study design, sample size calculations and consultancy advice during the start-up of a study.
Creating Statistical Analysis Plans (SAP) and Output Shells
We ensure innovative approaches to the statistical content of a study to increase the chances of a successful trial.
Interim Analysis/Data Safety Monitoring Boards (DSMBs)
We offer support at the start of the trial to set up the documentation for DSMBs and study designs to incorporate interim analysis.
Statistical Review of CRFs
With cross functional support for Clinical Data Management customers, CRFs are reviewed to ensure data collection endpoints are appropriate and necessary for the trial's objectives.
Study Reporting
With a flexible approach, our dedicated team of data experts can help increase your data quality and save you time and deliver a high-quality deliverable to support clinical development plans and regulatory compliance.
ISS/ISE
We provide support for the integrated summaries of safety and integrated summaries of efficacy data prior to regulatory approval.
Clinical Data Interchange Standards Consortium (CDISC)
Using CDISC standards ensures that the data used in the outputs produced complies with regulatory standards.
Output Production
Using SAS ® Programming and R Programming to ensure increased efficiency when producing study report outputs.
Production of Statistical Reports/Statistical Review of Clinical Study Reports (CSRs)
Our statistical and medical writing teams collaborate to produce high-quality reports which display the study reporting results of trials.
