Biometrics
ISS/ISE Reporting
Integrated summaries 100% on-time submission rate to the FDA and EMA
We have extensive experience in planning, managing and implementing the work required for data integration when preparing integrated summaries, both for ISS/ISE and other regulatory submissions.
Every project is unique, and we are experts at tailoring reporting requirements to efficiently and effectively meet your needs and the needs of the regulatory authorities.
As your partner, we’ll leverage our indication-specific experience to guide you through the full statistical programming and biostatistics processes, including:
Communication
Budget
Operational
Timeline
Our Approach
- Planning and Project Management: detailed project plan development, resource planning, risk management and project monitoring
- Gap Analysis & Data Integration Plan: review of all available documentation and data for the studies to be integrated and creation of a Data Integration Plan
- Statistical Analysis Plan: definition of the statistical methodology, algorithms and mock shells to be used for presenting the integrated data
- Data Migration: after the migration of all datasets to the same consistent standard, data integration can begin according to the data integration plan
- Analysis and Reporting: usage of the most up-to date templates and regulatory guidance to create the final integrated summary documents
Why choose Alira Health?
The CROS NT and Alira Health biometrics team has provided expert statistical guidance for over 500 projects, including regulatory communication and submissions, study-based data management, biostatistics, and statistical programming. You will benefit from our:
- Exceptional customer service and site relations
- In-depth expertise across the entire clinical trial process
- Flexible and tailored service delivered by multidisciplinary and global teams
- Frequent, transparent, and professional communication
- Guarantee we will lead your study efficiently, safely, and successfully