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

Effective management of the internal and external cross-functional teams, ensuring timely responses to questions

Budget

Tailored budget proposal based on your needs, study complexity, the format and consistency of existing data

Operational

Diversity of study data and presence of documentation, data harmonization process can be complex. Our expert programming team have an excellent track record in overcoming obstacles in data conversions

Timeline

Fixed submission dates can be challenging and necessitate flexibility. Our teams can adapt and respond rapidly to change

Our Approach

Five steps to effective Integrated Summaries

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: