discover.signanthealth.comhs-fshubfsUse- Logo for Promo items-03

The eCOA Platform
Built for Regulatory Approval

underline

Signant Health's eCOA platform delivers submission-ready data that regulatory agencies trust. Our built-in quality controls ensure your data meets FDA, EMA, and global standards - defensible 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?
underline

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. That's because Signant is built on the 4S's - Solution, Science, Service, and Scale - the essential ingredients for successful eCOA.

33-1

SOLUTION

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

4s (3)

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.

30

SERVICE

Expert implementation teams in your time zone, backed by proven processes. From consulting and license management to device logistics and multilingual patient support - we're with you at every step.

31

SCALE

Robust architectural and operational capacity built for global scale. Seamlessly expand from early-phase local trials to multinational pivotal studies.

Ready to experience the 4S advantage?

Request your free protocol review now.

REQUEST PROTOCOL REVIEW

FAQs

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?

Signant Health Logo

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.