Biostatistics
Bridging the gap between clinical data and approval
Utilize the true potential of statistical analysis to move your clinical research from planning to market rapidly with our biostatistics services
Biostatistics sit at the core of every clinical study enabling life sciences and pharma companies to make informed scientific decisions, fine-tune research and provide enhanced value. IQA offers a wide range of expert biostatistics services for clinical trials across phases. We apply innovative statistical concepts to design and facilitate successful clinical trials right from protocol design through regulatory submission.
In addition to wide experience across therapeutic areas, early phase development, and PK/PD analysis applying innovative statistical methodologies. Our Biostatisticians work closely with clinical data management team and statistical programming team to ensure data quality and faster completion. We constantly work on improving our biostatistical capabilities through regular knowledge-centric programs including global conclaves, scientific publications, internal discussion sessions, etc.
Backed by expert grasp of diseases and compounds, our biostatistics team provide assistance in:
- Speeding up clinical trials
- Maintaining consistency, quality and integrity
- Avoiding humanly delays with tech competence
- Optimizing processes across phases for efficiency
Our Biostatistics services include
Planning
- Clinical Trial Design
- Synopsis Development
- Protocol Development
- Power Analysis & Sample Size Calculation
- Randomization Schedule
- Review of CRF
- Adaptive Trial Design
- Bayesian Model
Execution
- Statistical Analysis Plan Development
- Mock-up Shells Development
- ADaM Datasets Specifications
- Interim Analysis
- Unblinded Analyses for DMC, DSMB, etc
Analysis and Reporting
- Review of ADaM datasets
- Review of Tables, Listings and Figures
- PK/PD Analysis
- Statistical Analysis and Interpretation
- ISS/ISE Analysis
- Patient Profiles
- IVIVC
- Ad-hoc Reporting
Submission
- Writing Statistical Aspects of CSR
- Study Report
- Meta Analysis
- Support for Publications
IQA has decades of experience in applying the latest statistical methods and techniques to enhance clinical studies. Our team of biostatisticians continuously work towards keeping themselves updated of regulatory revisions, key industry updates and innovations in the space of technology. Our approach includes tight collaboration with our clients to understand their study specificities and design an ideal solution.
Precision in clinical trials begins with strong statistical analysis
At IQA, we’re committed to providing high-quality clinical biostatistics services that help to advance clinical research and improve results.