Good eCOA is Science & Technology in Equal Measure

With 50+ in-house clinical scientists, Signant embeds measurement science into every stage of the eCOA lifecycle, from endpoint strategy to final implementation.

DISCUSS YOUR PROTOCOL

The Most Valuable eCOA Decisions Are Made Early

The most consequential decisions in a clinical outcome assessment strategy are made before the eCOA build begins. Instrument selection, recall period, frequency of assessment, endpoint hierarchy, and measurement modality are all determined at protocol stage. Sponsors who bring scientific expertise to bear at this point are better positioned to develop endpoints that hold up to regulatory scrutiny, with less rework and greater confidence in the measurement strategy as the study progresses.

Science and Technology Working Together,
Across the Full Study Lifecycle

Signant's approach to eCOA is built around three points where measurement science has the most influence on study outcomes.

1

Before the Build:
Protocol and Study Design

Signant's team of 50+ clinical scientists works with sponsors at protocol stage to support instrument selection, measurement strategy, and measure development. For sponsors developing novel measures, Signant provides tailored ePRO instrument development consulting, including co-development with instrument authors where appropriate. The epilepsy seizure diary, developed in collaboration with the Epilepsy Study Consortium, is one example of this approach in practice.

2

In the Platform: Measurement Science by Design

The way an eCOA instrument is presented to a patient affects the quality of the data it generates. Signant's platform is built with measurement science principles embedded in the design environment, covering display formatting, response scale presentation, recall period configuration, and assessment frequency logic. The result is an eCOA build where the platform's own design standards protect the integrity of the instrument.

3

At Implementation:
Steering Delivery to the Best Scientific Outcome

When an eCOA study moves into implementation, Signant's science team can remain actively involved. Where scientific oversight is applied at this stage, it ensures that every implementation decision, from how instruments are configured to how sites are trained, reflects measurement best practice. The aim is to ensure the study is designed and built to the scientifically best interpretation of what the protocol requires.

Proven at Scale

Deep Regulatory Experience,
Across Every Stage 

Signant's science team has supported more than 100 regulatory submissions across 20+ therapeutic areas, with dedicated specialists in CNS, oncology, rare diseases, vaccines, cardio-metabolic, and pediatrics. Regulatory scrutiny of COA endpoints continues to increase, and sponsors developing novel instruments or adapting existing ones for new populations or indications face a higher evidentiary bar. Signant's experience across more than 100 submissions means the team has direct knowledge of what regulators expect, and how to build a measurement strategy that meets that standard.

Expert Opinion, On Demand 

Scientific advisory boards in psychiatry, neurology, and internal medicine provide on-demand opinion-leader expertise for studies where additional depth is required. Sponsors working in established therapeutic areas benefit from accumulated scientific knowledge, while those in novel or emerging areas have access to the specialist input their endpoint strategy requires.

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Frequently Asked Questions

At what point in the study lifecycle can Signant's science team engage?
Signant's scientists can engage from the earliest stages of protocol design, including before an instrument has been selected or a measurement strategy defined. Early engagement is where scientific input has the most influence on study outcomes and regulatory readiness.
Does Signant support novel instrument development?
Yes. Signant provides tailored ePRO instrument and eDiary development for sponsors with unique study requirements, including adaptation of existing measures and supporting full custom instrument development where needed.
How does scientific expertise relate to the eCOA platform itself?
Measurement science principles are embedded in Signant's design environment. Display standards, recall period configuration, response scale formatting, and assessment frequency logic all reflect best-practice measurement science, so platform design decisions support rather than compromise the quality of the instrument.
What regulatory support does Signant provide?
Signant's science team supports PRO dossier development, regulatory submission planning, and agency meeting preparation.

WHO IS SIGNANT HEALTH

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 over 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.