Biostatistics is an important aspect for all investigational drug or device development programmes to determine the efficacy and effectiveness in clinical trials. This includes the study designs, study conduct, determining the most effective data collection points and how analysis and reporting should be performed.
Kaairosh’ biostatisticians aim for quality and implement the best approach to a sponsor situation / scenario to ensure proper analysis. Using the appropriate tools, we demonstrate the efficacy and safety of a medical product and present the results in the clearest way possible.
Ensure you have the best chance of success in proving your efficacy and safety with our expert Statistical Programming Services
Our expert programmers have detailed knowledge of all Phases and experience of in multiple therapeutic areas across the product development spectrum making us an ideal fit within existing project teams at client sites or to form the basis of new teams, forming long lasting partnerships.
Range of Services:
Kaairosh provides all levels of support from bespoke biostatistical consultancy for protocol design, calculation of sample sizes, power calculations, and/or the production of study randomization, through to study level analysis of Tables, Listings and Graphs.
Therapeutic Areas
Kaairosh has experience across a wide range of therapeutic areas, all phases of research and development. Our scientific principles will guide you throughout your trial ensuring high quality data with your clinical trial reporting to support your regulatory submission.
Study Setup
- Protocol Review & Writing – our input includes writing of statistical analysis section, clinical study design, sample size calculations and advice during the start up of a study.
- Randomization/Unblinding – our statistician will be able to create randomisation codes as per the study design which will also include emergency unblinding envelopes
- Creating Statistical Analysis Plans (SAP) and Output Shells – we provide innovative approaches to the statistical content of a study to increase the chances of a successful trial. By using standardized output shells, we ensure a smooth transition to Programming when using our validated macros.
- 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 for the trials objectives.
STUDY REPORTING
- ISS/ISE – we provide support for the integrated summaries of safety and integrated summaries of efficacy data prior to regulatory approval.
- Output Production – using your systems or Kaairosh’ standard macros with SAS ® Programming ensures increased efficiency when producing study report outputs.
- PK/ PD Analysis
- Clinical Data Interchange Standards Consortium (CDISC) – using CDISC standards ensures that the data used in the outputs produced complies with regulatory standards.
- Statistical Reports/Statistical Review of Clinical Study Reports (CSRs) – we produce high quality reports to display the study reporting results of trials which are then used by Medical Writing to create CSRs.