Clinical Biostatistics Services | Biostatistics CRO

Biostatistics CRO

Biostatistics is necessary 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.

Quanticate’s biostatisticians have a desire for quality and implement the best approach to a client situation/scenario to ensure correct analysis without an over complex process. By using the appropriate tools, we are able to demonstrate the efficacy of a drug and present the results in the clearest way possible.

Protocol Review & Writing – our input includes writing of statistical analysis section, clinical study design, sample size calculations and consultancy advice during the start up of a study.
Randomization/Unblinding – we offer production of randomizations including production of emergency unblinding envelopes.
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. 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 functionally support for Clinical Data Management customers, CRFs are reviewed to ensure data collection endpoints are appropriate and necessary for the trials objectives.

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 Quanticate's standard macros with SAS ® Programming and R Programming ensures increased efficiency when producing study report outputs.
PK/PD Analysis - non-compartmental analysis using Phoenix WinNonlin® and statistical analysis with the relationship between exposure and response modeled using non-linear models and the use of non-linear mixed effect modeling.
Clinical Data Interchange Standards Consortium (CDISC) – using CDISC standards ensures that the data used in the outputs produced complies with regulatory standards.
Meta Analysis – our expert statisticians can advise on potentials for bias during a Meta Analysis as well as on statistical methods to use.
Production of 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 in the creation of CSRs. We also review these CSRs from a statistical perspective generated to ensure statistical integrity is up held.
Production of Statistical Report/Clinical Study Report – our statistical and medical writing teams collaborate to produce high quality reports.