Regulatory Statistics
Statistical Consulting to Ensure Compliance and Accuracy
The application of statistical methods in clinical research is both fostered and constrained by an ever-changing regulatory landscape. How can you stay on top of shifting regulations so your clinical trial remains compliant, and your clinical development plan is successful?
By uniting state-of-the-art statistical methods and up-to-date regulatory knowledge, IDDI’s regulatory statistics solution will optimize your clinical development strategy to ensure your statistical methods meet regulatory requirements and are scientifically sound.
Comprehensive Regulatory Statistics Services
IDDI statistical consultants have a deep statistical acumen and thorough understanding of regulatory principles, offering you solutions like:
- Adaptive clinical trial designs
- Accelerated approval
- Dose optimization
- Sequential testing
- Use of real-world evidence (RWE)
- Patient-centric research
- Selection and hierarchy of endpoints
- Implications and validation of biomarkers in precision medicine
- Analysis populations
- Choice and implementation of randomization methods
Industry-Leading Statistical Innovation and Regulatory Expertise
Striking the right balance between innovation and regulatory constraint is a challenge our statistical consultants meet with confidence that stems from three decades of experience and a proven track record.
Statistical innovation is in IDDI’s DNA, as shown by our continual investment in R&D and creation of spinoff businesses built on novel, homegrown statistical methods. Our statistical consultants are also deeply familiar with regulatory thinking, guidance documents, and accepted precedents. When you need to optimize your clinical development plan while remaining compliant, you need our Regulatory Statistics solution.
