Delivering what you need
Biostatistics is a key element of a clinical trial and needs to be handled with expertise and attention to details. At INNOPHARMA, we take time to understand your specific requirements and provide an exceptional level of service. Whether you require our services as an integral part of a full clinical trial program, or as a stand-alone consulting or training service, INNOPHARMA’s biostatisticians and consultants can quickly step in to make significant contributions to your study.

Biostatistical Consulting
INNOPHARMA’s experience and resources make us a natural choice for biostatistical and programming consulting.

With an average of more than 15 years industry experience, our consultants are experienced, motivated, and focused on your needs. They offer knowledgeable advice ranging from individual trial design to complete product development programs.

  • Protocol development and review
  • Sample size calculations
  • Statistical help desk for statistical consulting needs
  • Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs)
  • Meta analysis
  • Support and review of publications
  • Conference presentations
  • Marketing support

Analysis Services
The biostatistics and programming professionals at INNOPHARMA focus on your needs. With our professionals team we can provide an expert to suit your needs and you can be confident that your projects get the individual attention they deserve.
All design, analysis and reporting is based on ICH guidelines, client needs, and our own procedures. Rigorous QC methods are employed at all stages.

  • Statistical aspects of study design
    • Design alternatives
    • Input into protocol
    • Sample size calculations
    • Randomization
    • CRF design review
  • Statistical analysis planning
    • Analysis planning meetings
    • Methodology development and evaluation
    • Production of analysis plan
  • Data analysis
    • Analysis, table, figure and appendix programming
    • Blind review of protocol violations
    • Classification of patients into analysis sets
    • Independent QC through double programming and peer review
  • Reporting
    • Presentation formatting
    • Statistical reporting
    • Integrated clinical and statistical reports

Training
Clinical Statistics for the Non-Statistician
The courses of Statistics for Clinical Trials:

  • Provide a clear explanation of clinical statistics and its impact on clinical trials
  • Use friendly, understandable language with real-life experiences
  • Teach how to interpret/review the statistical aspects of protocols or publications

These courses can be customized to meet your requirements or you can choose from the range of tailored courses available for Data Managers, Medical Writers or for Clinical Research Associates

Biostatics for Statisticians
For statisticians in the pharmaceutical industry the following courses are available:

  • Analysis of Survival Data
  • Analysis of Binary and Categorial Data
  • Equivalence and Non-Inferiority Trials
  • Adaptive Design

These courses explain the application of the statistics to the clinical trial setting, keep up-to-date with the latest methodology and frequently refer to regulatory guidelines.