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The eCOA Platform
Built for Regulatory Approval

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Signant Health's eCOA platform transforms regulatory risk into approval confidence. Our solutions generate submission-ready data that meets global regulatory standards, with built-in quality controls that ensure defensibility from protocol design through NDA filing.

Connect with our experts for tailored, no-pressure guidance on your study protocol, data quality, and compliance

Powering 25% of successful FDA & EMA drug approvals.
Get the eCOA platform that regulators trust.*

6,200+
TRIALS SUPPORTED

25
YEARS OF EXPERIENCE

100+
COUNTRIES DEPLOYED

Why Do Sponsors Behind 25% of Successful Drug Approvals Choose Signant?
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Because when years of research and regulatory approval are on the line, clinical teams can't afford data quality surprises. Top Pharma and Biotechs choose the platform with a proven track record of regulatory success for peace of mind. Signant's 4S methodology has been proven to deliver high quality data, backed by science for trial success. 

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SOLUTION

Our comprehensive technology offers ePRO, complex ClinRO, as well as the tools and reporting needed by sponsors and sites, without surprise capability gaps

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SCIENCE

Over 50 full-time clinical and eCOA experts proactively guide and monitor the study from protocol design through regulatory submission, ensuring the best solutions and best practices are in place to generate reliable evidence

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SERVICE

Scale acquisition and implementation expertise, translation services, device provisioning and logistics, patient-facing local language helpdesk, and operational infrastructure enable hassle-free implementations for simple or complex studies in any indication and in any time zone

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SCALE

An end-to-end platform with mature global operational infrastructure enables you to seamlessly scale from early phase, local trials to multinational pivotal trials

Ready to apply the 4S methodology?

Request your free protocol review now.

REQUEST PROTOCOL REVIEW

FAQs

What happens during a protocol review?

We evaluate whether your planned eCOA approach will generate submission-ready data by reviewing endpoint validity, data integrity, and alignment with therapeutic area-specific regulatory requirements. This ensures your process is built for compliance and approval from the outset.

How do you assess our regulatory risk?

We assess whether your planned eCOA approach will generate submission-ready data, focusing on endpoint validity, data integrity, and compliance with therapeutic area-specific requirements.

Do you work with our specific therapeutic area?

We've supported eCOA implementations across all major therapeutic areas, including CNS, oncology, rare disease, and cardiovascular studies, understanding the unique endpoint and regulatory requirements for each.

Can you help if we're already using another eCOA platform?

Yes, we provide eCOA consultation regardless of your current technology choices, focusing on endpoint optimization and regulatory compliance best practices.


*2021–2024. Signant Health technology and services supported approximately 25% of all regulatory authorizations for new active substances in their first indications, as defined by FDA Novel Drug Approval and EMA Marketing Authorization for New Active Substance, across major global markets.

WHO IS SIGNANT HEALTH?

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Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 25 years, over 600 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, EDC, eConsent, RTSM, supply chain management, and data quality analytics.
Learn more at www.signanthealth.com.