The biostatistics and programming professionals at PAREXEL focus on your needs. With a team of more than 100 professionals across the globe, from programmers to consultants, we can provide an expert to suit your needs - 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 extensive procedures. Rigorous QC methods are employed at all stages.
Statistical aspects of study design:
- Design alternatives
- Protocol input
- Sample size calculations
- Randomization processes and schemes
- CRF/database design and review
Statistical analysis planning:
- Analysis planning meetings
- Methodology development and evaluation
- Production of analysis plans
Data analysis:
- Blinded review of protocol violations
- Analysis, table, listing and graph production
- Classification of patients/subjects into analysis datasets
- Independent QC through double programming and peer review
Reporting:
- Presentation formatting
- Statistical reports
- Integrated clinical and statistical reports
ISS/ISE – Keeping the End in Mind:
- Development, documentation and reporting
- Interface with Regulatory Authorities
- Creation of integrated databases
Analysis services for Data Monitoring Committees:
- Independent statistical reports
- Safety review
- Interim analysis
Quality Control services:
- QC of client analysis and reports
- Independent reprogramming and review
BIOSTATISTICAL CONSULTING
Many companies can offer statistical analysis and reporting. However, you may have specialized needs that go beyond this. PAREXEL’s extensive experience and global resources as a top biopharmaceutical services provider make us a natural choice for biostatistical and programming consulting.
With an average of more than 10 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 design, development and review
- Sample size calculations and randomization schemes
- Auditing statistical analysis plans
- Auditing statistical analyses
- Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs)
- Statistical methods for detection/evaluation of fraud
- Meta analysis
- Support and review of publications
- Conference presentations
- Marketing support
- Representation of clients at FDA, MCA, and other regulatory agencies and meetings
- Expert panels