A Global CRO

 

Biostatistics

One of Amarex's core competencies is statistics and programming. Our statisticians and statistical programmers offer years of industry experience and therapeutic knowledge to assist our sponsors with a full range of statistical and programming services, in addition to Adaptive Trial design and DSMB presentation.

Statistical inputs to protocol:
  • Study design including designing adaptive clinical trials
  • Protocol development
  • CRF review
  • Sample size calculation
  • Subject randomization and blinding

Preparing Statistical Analysis Plan (SAP) and performing analysis including:
  • Support of the development of investigator brochures
  • Integrated safety and efficacy summaries
  • Meta-analysis
  • Adhoc and Post-hoc analysis
  • Post-marketing safety reports
  • DSMB analysis and reports
  • Annual reports
  • Abstracts, manuscripts, presentations and posters

Performing supportive analysis:
  • Interim analysis
  • Sample size re-estimation
  • Exploratory data analysis of completed studies for publications
  • Signal detection, planning and designing new studies

Randomization:
  • Block size
  • Stratification
  • Blinded or Unblinded depending upon study design

Statistical Analyses and Programming:
  • Support and production of Tables, Listing and Graphs (TLGs) for Pre-clinical, Bioequivalence and Clinical Trials (Phase I, II and III) based on pre-defined objective and hypothesis and interpretation of the results
  • Support for health economics, outcome research-retrospective, and outcomes research-observational studies
  • Support for medical devices studies and diagnostic kits
  • Pharmacokinetic and pharmacodynamic data analysis and modeling
  • Analysis and reporting of pre-clinical data
  • Statistical consultation to clinical research and market support professionals
  • Preparation of RAW and Analysis datasets using CDISC standards for statistical analyses and drug submissions to regulatory agencies

These services are provided following ICH-GCP and regulatory guidelines and using well-designed workflow processes and standard operating procedures (SOPs), including templates for study protocols, statistical analysis plans, statistical analysis and programming QC/QA plans, statistical reports, and clinical study reports.