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Defensible evidence, engineered for regulatory approval.

The evidence generation partner trusted by 600+ sponsors, including all Top 20 pharma, to meet regulatory scrutiny at every stage. From the protocol decisions that shape your endpoints to the submission that depends on them.

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Supporting 25% of novel drug approvals across FDA and EMA.*

6,000+
TRIALS SUPPORTED

600+
SPONSORS

100+
COUNTRIES

25+
YEARS EXPERIENCE

From emerging biotech to global pharmaceutical leaders, sponsors trust Signant to generate defensible evidence across every phase of development. Our technology and science deliver trials across oncology, CNS, rare disease, cardiovascular medicine, and beyond.

Evidence quality is determined long before submission.

1

The way you define and operationalize endpoints shapes how defensible your evidence will be.

2

Patient experience data is most reliable when capture fits naturally into patients' lives.

3

Complex protocols only work when therapeutic expertise and technology are designed together, not in sequence.

4

Global trials demand infrastructure that assumes variability in sites, patients, and regulations from day one.


These aren't observations about the industry. They're principles Signant has built into every study it supports.

How Signant delivers defensible evidence.

We don’t treat technology, science, service, and scale as separate pillars. The value comes from how they work together in practice on every trial.

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SOLUTION

An eClinical platform built to cover complex protocols end-to-end, across eCOA, EDC, RTSM, and supply chain management.

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SCIENCE

Measurement science and therapeutic expertise embedded in the platform, from endpoint definition and instrument selection through to study completion.

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SERVICE

Experienced study teams and project management that understand the science, not just the software, with 24/7 multilingual support when trials demand it.

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SCALE

Global infrastructure proven in 6,000+ trials and 100+ countries, ready for complex, multinational studies from day one.

Evidence-driven technology across every part of your trial

Strengthen the Evidence Behind Your Next Submission

Trusted by 600+ sponsors, including all Top 20 pharma, when regulatory scrutiny is highest. From protocol decisions to submission, we help you generate evidence that holds up.

REQUEST A PROTOCOL EVIDENCE REVIEW

FAQs

How does Signant support protocol-stage endpoint decisions?

We work with sponsors early, reviewing draft protocols and endpoint strategies with our scientific teams to ensure they can be operationalized in eCOA, DHT, and clinician assessments without weakening the science. That guidance feeds directly into instrument selection, visit schedules, and evidence capture design so endpoints remain both feasible and defensible.

What makes Signant’s approach to evidence quality different?

We don’t treat technology, science, and operations as separate tracks. Our platform, measurement science, and study teams are designed to work together, from how endpoints are defined, to how data are captured and monitored, to how evidence is packaged for regulators, so quality is protected at each step instead of inspected at the end.

How do you work with sponsors across therapeutic areas?

Our teams have supported 6,000+ trials across oncology, CNS, rare disease, cardiovascular medicine, and other complex indications. We bring indication‑specific scientists, validated instruments, and operational playbooks to each study, then adapt them to the sponsor’s protocol and scientific requirements.

How early should we involve Signant in a study?

The highest impact comes when we engage at protocol or concept stage. That’s where we can help shape endpoint strategy, instrument selection, visit schedules, and data‑capture plans so they’re both operationally feasible and scientifically defensible, before design decisions get locked in.

Do we need to replace our existing technology stack to work with Signant?

Signant works alongside many existing eClinical systems and vendor relationships. We commonly connect with sponsors’ current EDC, data management, and site technologies, then apply our strengths in eCOA, DHT, rater workflows, RTSM, and supplies where they have the biggest impact on evidence quality. Integration depends on your specific setup, and our teams work through it early in the engagement.

*Signant Health's technology and services have supported a quarter of all regulatory authorizations for new active substances in their first indications across major global markets. 2021-2024. Regulatory authorization for new drug for first indication, defined as Novel Drug Approval by FDA, and Marketing Authorization for New Active Substance by EMA.

WHO IS SIGNANT HEALTH?

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Signant Health is the evidence generation company, leveraging software, deep therapeutic and scientific knowledge, and operational expertise to deliver quality evidence across traditional, virtual, and hybrid trial models. For more than 25 years, 600+ sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant's comprehensive eClinical solutions. Our clinical outcome assessments (eCOA, clinician ratings, cognitive testing) and wearable digital health technologies powered by Ametris provide the industry's most comprehensive evidence generation capabilities alongside EDC, eConsent, RTSM, supply chain management, and data quality analytics. Learn more at www.signanthealth.com.