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A single, unified SaaS solution for all EU Phase 4, Real-World Evidence, and Post-Approval studies
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Latest in the hub
A Tutorial on Modern Bayesian Methods in Clinical Trials
Published: May, 2023
Specific Requirements for Integrated Summaries of Efficacy and Safety in FDA Submissions
Published: May, 2023
Webinar on Advancing Patient Engagement in the Medical Device / MedTech Industry
Published: May, 2023
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Home > Home
Comprehensive Guide to the Content of Integrated Summaries of Efficacy and Safety (ISE/ISS)
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Idea.
Innovation.
Transformation.
Humanizing Healthcare.

A full spectrum of patient-centric data and tech-enabled services to accelerate innovation and deliver tomorrow’s standard of care

Check out our latest expert materials
News May 22, 2023
Alira Health Joins France Biotech as an Expert Partner
Blog May 19, 2023
Content of the Integrated Summaries of Efficacy and Safety
Multimedia May 17, 2023
Webinar: How to Increase Patient Engagement in Your Clinical Trials
Discover more

Our Mission is to Humanize Healthcare.

Our integrated team collaborates to fully understand every aspect of your business and offers an unmatched continuum of support across your full solutions lifecycle

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From idea to impact, Alira Health unites medical innovation and medical care

Transaction Advisory Icon Transaction Advisory Management Consulting Real-World Evidence Advanced Analytics Patient Engagement Product Development Regulatory Icon Regulatory Clinical Icon Clinical Market Access

Patient Care

at the center of everything we do

From idea to impact, Alira Health unites medical innovation and medical care

Clinical Icon

Patient Care

at the center of everything we do

Transaction Advisory Transaction Advisory Management Consulting Management Consulting Real-World Evidence Real-World Evidence Advanced Analytics Advanced Analytics Patient Engagement Patient Engagement Product Development Product Development Regulatory Regulatory Clinical Clinical Market Access Market Access

News from Alira Health

News May 30, 2023
A Tutorial on Modern Bayesian Methods in Clinical Trials
New advancements in modern computation power have led to increasing interest in Bayesian methods.
Complex Innovative Design
Blog May 30, 2023
Specific Requirements for Integrated Summaries of Efficacy and Safety in FDA Submissions
This article in our Content of Integrated Summaries of Efficacy and Safety series focuses on specific requirements for FDA submissions.
Biometrics ISE/ISS
Multimedia May 26, 2023
Webinar on Advancing Patient Engagement in the Medical Device / MedTech Industry
Engaging with patients, including their caregivers and advocates, is crucial during the planning and execution of clinical trials.
Medical Devices MedTech Patient Engagement
Publications May 25, 2023
The EU Pharmaceutical Package: Introduction to Changes
Alira Health’s Regulatory experts explore how the proposed package will disrupt the European regulatory landscape and what it means for companies.
EU Pharma Regulatory
Blog May 24, 2023
Planning: Why It’s Worth the Time for Biotech Companies
Biotech expert Joris Pezzini covers the fundamentals of planning, one of the three required jobs for biotech leaders to be successful.
Biotech
News May 22, 2023
Alira Health Joins France Biotech as an Expert Partner
We are pleased to announce that Alira Health has joined France Biotech, an independent association that brings together healthcare innovation entrepreneurs and their expert partners.
Biotech Clinical Trials France Patient Engagement
Blog May 19, 2023
Content of the Integrated Summaries of Efficacy and Safety
This article in our Content of ISE/ISS series focuses on what elements are required in the ISE/ISS to ensure a successful submission.
Biometrics ISE/ISS
See all news

 

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