Published on April 01, 2026
Platform update
Twelve validated instruments secured across four therapeutic areas. Nearly 10 registration-track trials live on the platform. Here is what the eCOA team delivered in the second half of last year.
~10
New commercial Phase II/III eCOA studies launched in H2 2025
12
Validated instruments secured across four therapeutic areas

Nearly 10 new commercial Phase II and Phase III trials began capturing endpoint data on the Castor eCOA platform in the second half of 2025. The studies span multiple indications, including targeted oncology therapies, immunology, and chronic pain. In the same period, Castor’s eCOA team secured copyright approvals for 12 validated instruments across four therapeutic areas.

That combination reflects what Phase II/III eCOA deployment actually requires. Registration-track trials carry the highest compliance bar in clinical outcome assessment work. Before a single patient completes a digital assessment, the platform must hold an active copyright license for the instrument, carry the validated translation for each study language, and have documentation in place for regulatory inspection. The instrument procurement work completed in H2 2025 directly enabled these deployments.

Instruments secured in H2 2025

The 12 validated instruments cover four therapeutic areas. They are now available for deployment on the Castor platform as part of full-service eCOA study support.

Therapeutic area Instruments What they measure
Dermatology PP-NRS
SP-NRS
PGIC
PGIS
Patient-reported and clinician-rated severity measures for skin conditions, including pruritus and pain numeric rating scales and global impression scores
Asthma and respiratory ADSD
ANSD
ACQ
AQLQ(S)
Daytime and nighttime symptom burden scales, asthma control questionnaire, and standardised health-related quality-of-life measure for respiratory trials
Obesity and rare disease IWQOL-Kids
IWQOL-Lite
PHQ-A
Weight-related quality-of-life questionnaires for pediatric and adult populations (IWQOL-Kids, IWQOL-Lite); adolescent depression and anxiety screener used as a comorbidity assessment (PHQ-A)
Oncology EORTC QLQ-C30 Core patient-reported outcomes questionnaire used across European and global cancer trials, developed by the European Organisation for Research and Treatment of Cancer

What this signals

Commercial-phase eCOA work has grown significantly on the Castor platform over the past 12 months. The driving factor is a shift among biopharma sponsors toward platforms that handle copyright licensing, instrument configuration, and clinical data management in one place, rather than coordinating instrument rights separately from their electronic data capture system.

Phase III timelines have no slack for instrument procurement delays. Copyright negotiations, linguistic validation, and copyright holder approvals for the digital format each take time. The 12 instruments secured in H2 2025 expand the coverage available to sponsors preparing to launch registration-track studies in 2026 without starting from zero on instrument rights.

The H2 2025 studies span a range of indication types, reflecting broader adoption of clinical trial solutions purpose-built for clinical outcome assessment work at the commercial stage, beyond the academic and Phase I deployments that have historically made up the majority of eCOA usage.

Running a Phase II or III trial with clinical outcome endpoints?

Talk to our eCOA team about your instrument requirements and study timeline.

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Frequently asked questions

What is eCOA and how does it differ from ePRO in Phase II and Phase III clinical trials?
Electronic clinical outcome assessments (eCOA) is the broader category covering all digitally administered outcome measures: patient-reported outcomes (ePRO), clinician-rated assessments (eClinRO), observer-reported outcomes (eObsRO), and performance outcomes (ePerfO). In Phase II and Phase III registration-track trials, both patient-reported and clinician-rated instruments frequently appear as primary or secondary endpoints. Regulatory agencies including FDA and EMA require that all instruments be copyright-licensed, validated for the digital format, and deployed on a 21 CFR Part 11-compliant platform with a full audit trail.
What does copyright licensing for validated clinical outcome instruments involve?
Validated clinical outcome measures such as the EORTC QLQ-C30 and AQLQ(S) are copyright-protected. Before deploying them digitally in a clinical trial, the platform must hold an active license from the copyright holder covering the specific instrument, language version, and mode of administration. This includes the right to digitize the instrument, use the validated translation, and deploy it within the study design. Negotiating these rights directly with instrument developers can take weeks to months per instrument per language.
Which therapeutic areas does Castor support for commercial eCOA studies?
Castor supports eCOA deployments across dermatology, respiratory diseases, obesity, rare diseases, oncology, immunology, and additional indications. The platform holds copyright approvals for instruments including the EORTC QLQ-C30, ACQ, AQLQ(S), PP-NRS, SP-NRS, PGIC, PGIS, IWQOL-Kids, IWQOL-Lite, and PHQ-A. The eCOA team handles licensing, platform configuration, and regulatory documentation as part of full-service study support.