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eCOA, Connected to Your RTSM

Electronic clinical outcome assessment is how you collect outcome data directly from participants, clinicians, observers and sites, on a device rather than on paper. It carries your endpoints, so the quality of that data decides what your study can claim.

We deliver eCOA with Kayentis, and we connect it to your randomization and supply system so the two behave like one.

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Pre-built integration designed to save up weeks and up to $50k per project, with up to 100% reduction in data retranscription between eCOA and RTSM.

What eCOA Involves

The right setup depends on your endpoints, your visit schedule and how much of the study happens outside the site.

Participant, clinician and observer data

Participant, clinician, observer and site-reported data, captured through the same platform.

Site-based, hybrid and decentralized designs

Including studies that mix all three across regions.

Devices and languages

BYOD or provisioned devices, plus language coverage, so a multinational study runs on one instrument set.

Connected digital health technologies

Instruments such as actigraphy and blood glucose devices, feeding the same record.

Scientific support across the lifecycle

From protocol review through to study archiving.

Rater training

Where consistency between assessors affects the endpoint.

Where eCOA Gets Difficult

A common source of friction is operating eCOA and RTSM as separate systems.

  • The same data entered twice, once in eCOA and once in the randomization system, with the reconciliation work that follows.
  • Two vendors, two contracts, two qualification and audit cycles for the same study.
  • Integration built from scratch, specified and validated late in setup, on the critical path to go-live.
  • Two sets of UAT scripts and two go-live dates that have to be held together manually.
  • Protocol amendments implemented twice, in two change processes, at two speeds.
  • Sites logging in to more than one system, with support questions that bounce between helpdesks.

How We Approach eCOA

We deliver eCOA through Clin’Form, the platform of our partner Kayentis, and run it against ClinPhone Pro as a single engagement.

One connection, already built

A standard API integration between Clin’Form and ClinPhone Pro, pre-validated and reusable, designed to take integration off the critical path.

Near-real-time, both directions

Participant data synchronizes automatically between the two systems in near real time, with workflow triggers instead of manual transfers.

One entry per data point

Unified data flow is designed to remove duplicate entry between eCOA and RTSM, and the reconciliation burden that comes with it.

Linked participant status

Status is shared across both systems, which supports process control and gives monitors a consistent view. [ Planned, H1 2027 ]

One project lead

A single primary point of contact for project management, one master project plan, joint design and specification workshops, aligned UAT, and an aligned go-live for both systems.

Amendments handled once

Joint management of protocol amendment implementation across eCOA and RTSM.

One helpdesk

Synchronized support across both solutions, with global coverage in 140+ languages.

Simpler vendor administration

A single contract for eCOA and RTSM, with one qualification and audit path. [ Planned, H1 2027 ]

One login for sites

SSO across the integrated solutions. [ Planned, H1 2027 ]

Which Solution Delivers It

Clin'Form

The eCOA platform, delivered with Kayentis, for site-based, hybrid and decentralized designs.

Explore Clin'Form

ClinPhone Pro Core

Ready-to-deploy RTSM on proven configurations, for studies that do not need heavy customization.

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Expert POV
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Frequently Asked Questions

What is eCOA?

Electronic clinical outcome assessment is the electronic capture of outcome data reported by participants, clinicians, observers or site staff, replacing paper diaries and questionnaires.

Who provides your eCOA platform?

Clin’Form, from our partner Kayentis. We deliver it alongside our own RTSM, under one project team.

Why integrate eCOA with RTSM?

Because the two systems hold the same participant. Connecting them is designed to remove duplicate entry, cut reconciliation work, and keep randomization, dosing and outcome data consistent.

How long does the integration take to set up?

The Clin’Form and ClinPhone Pro connection is pre-built and pre-validated rather than specified from scratch, which is designed to shorten integration setup. Your study timeline still depends on protocol complexity and the wider system landscape.

Does eCOA work for decentralized and hybrid studies?

Yes. Clin’Form is designed to support decentralized, hybrid and site-based trials, and studies that combine them.

Can it connect to our other systems?

Yes. Our architecture is API-enabled and integrates with EDC, CTMS, depot and inventory systems alongside eCOA.

Talk Through Your eCOA and RTSM Setup

Tell us how your study collects outcome data today, and where it has to meet randomization. Our specialists will tell you what the connected version looks like.

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