ISS and ISE Support To Meet You Where You Are
Preparing an Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE) is one of the most critical—and complex—steps on the path to a successful marketing application. Whether you're planning ahead, preparing for submission, or addressing unexpected challenges, having the right expertise at the right time can make all the difference.
Our cross-functional team brings together biostatistics, medical writing, and regulatory strategy to support every stage of ISS and ISE development. Engage us for a single service or leverage our integrated team for end-to-end support—we'll meet you where you are.
Regulatory: Planning Your Submission Strategy
Lay the foundation for successful integrated summaries with early planning, regulatory insight, and a clear approach to data integration.
- Submission planning
- Data pooling strategies and FDA alignment
- Strategies for submissions without an ISE
- Strategies for submissions with study heterogeneity
- Cross-functional alignment
Biometrics: Preparing Your Data
Ensure your data is submission ready.
- Data integration and pooling
- Legacy data remediation
- CDISC conversion
- Statistical programming and analyses
Medical Writing: Preparing Your Documents
Our experienced medical writers and biostatisticians work together to transform complex data into clear, submission-ready integrated summaries that align with regulatory expectations.
- Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), and Integrated Summary of Immunogenicity (ISI)
- Submission-ready narratives
- Cross-functional document coordination
Integrated Delivery or Single Service
Bring all three disciplines together through a single, coordinated team focused on helping you achieve a successful submission. Or go a la carte and use one of our services to get just the level of expertise that you need.
Why Sponsors Choose Everest for ISS and ISE Support
Regulatory Submissions Experience and Expertise
Our team has supported more than 100+ marketing applications in 5 years. Sponsors trust us to set the pooling strategy, get alignment with FDA, submit the application, and answer IRs.
Solutions for Real-world Challenges
Data needs remediation? Concerned about study heterogeneity? We've been there. Our experts have helped sponsors navigate a wide range of ISS and ISE challenges. Whatever stage your program is in, let us problem solve for you.
20+ Years in Biostatistics
Everest was founded as a biometrics consultancy more than 20 years ago, giving us deep expertise in managing even the most complex clinical datasets. With highly experienced biostatisticians and statistical programmers, sponsors turn to us to solve their toughest data challenges.
Flexible Engagements
Need biostatisticians and programmers, but not the help of our regulatory team? Or vice versa? We work with sponsors to build a tailored plan to suit their individual needs.
Experience Matters: 100+ Marketing Applications in 5 Years
Read our case studies and get integrated analysis insights from our team of experts below.
The Top ISS and ISE Mistakes That Delay Regulatory Submissions
Over the years, our biostatistics and regulatory teams have supported hundreds of ISS and ISEs, giving us firsthand insight into the challenges sponsors commonly encounter. While many of these challenges are avoidable with the right planning and strategy, if left unaddressed, they can lead to significant rework and regulatory delays.
Overcoming Critical ISE and ISS Challenges on the Path to FDA Approval for an Oncology Biologic
In preparing the Integrated Summary of Efficacy (ISE) and the Integrated Summary of Safety (ISS) for a…
ISS/ISE and Regulatory Success for a GI Therapeutic
Everest helped a top-5 pharmaceutical company receive NDA approval for an Ulcerative Colitis treatment. Everest continues to…