Mastering Medical Writing For ISS And ISE: Maven’s Role In Pharmaceutical Regulatory Submissions

In pharmaceutical development, the creation of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) is essential for regulatory submissions. These documents combine safety and efficacy data from multiple clinical trials into a unified summary to support the approval and labelling of pharmaceutical products. However, the process is complex, requiring expert management and coordination.

Maven offers expert services to address the challenges involved in creating ISS/ISE. Here’s how Maven supports pharmaceutical companies through each stage of the process:

1. Early Planning and Coordination: Aligning Study Protocols and Endpoints

• Study Design Alignment: Maven collaborates with sponsors and CROs from the beginning to align study protocols, endpoints, and populations, ensuring that future data integration will be seamless.
• Minimizing Complexity: By addressing study design issues early, Maven helps reduce the complexities of integrating data from multiple trials with different designs and methodologies.

2. Clear Communication: Facilitating Collaboration Between Sponsors, CROs, and Regulators

• Continuous Communication: Maven emphasizes ongoing, clear communication between all stakeholders involved in clinical trials to ensure data is available, cleaned, and ready for integration.
• Stakeholder Alignment: Maven facilitates smooth collaboration among sponsors, CROs, and regulatory bodies to keep everyone aligned with timelines, data availability, and regulatory requirements.

3. Regulatory Expertise: Ensuring Compliance with Global Standards

• Global Regulatory Knowledge: Maven’s expertise in regulatory affairs ensures that the ISS/ISE meets the specific guidelines required by agencies like the FDA and EMA.
• Guidance on Regulatory Requirements: Maven provides guidance on structuring the ISS/ISE to meet the compliance needs of various health authorities, ensuring a smoother approval process.

4. Data Traceability and Management: Ensuring Accurate and Transparent Integration

• Data Validation: Maven ensures that all clinical trial data is cleaned, validated, and formatted correctly, allowing for accurate integration into the final ISS/ISE.
• Transparent Data Management: Maven maintains clear documentation and metadata management practices to ensure that all data is traceable, providing confidence to regulators during the review process.

5. Medical Writing Excellence: Communicating Complex Data Clearly

• Scientific Writing Expertise: Maven’s medical writers are skilled in transforming complex clinical data into clear, concise, and scientifically rigorous documents.
• Regulatory-Ready Documents: The medical writing team ensures that the ISS/ISE communicates data effectively while meeting the regulatory requirements of various health authorities.

6. Statistical Analysis and SAP Support: Aligning Methods with Study Objectives

• Statistical Planning: Maven develops a detailed Statistical Analysis Plan (SAP) early in the clinical trial process, ensuring that endpoints, time points, and statistical methods are well-defined.
• Data Integration Support: Maven’s statistical experts help align analysis methods across studies, ensuring that data from multiple trials are pooled effectively, resulting in a robust final summary.

Conclusion

Creating an Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE) is a complex process that requires careful planning, regulatory compliance, and expert data analysis. The challenges of data variability, study differences, and regulatory requirements can make this task daunting. However, with Maven comprehensive support, these challenges can be overcome. Maven’s services, including early study coordination, regulatory expertise, data traceability, medical writing, and statistical analysis, ensure that the ISS/ISE documents are of the highest quality, scientifically rigorous, and ready for submission.