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Jump to:
Categories
Solutions
Description
Compatibility Level
Clients
Use cases
EHR integrations
Client types
Differentiators
Keywords
Media
Company details
eSource
eSource

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Categories

Solutions

Description

Product Description:

Electronic Clinical Outcome Assessments (eCOA) collect and deliver accurate data for near real-time analyses. This easy-to-use solution keeps data clean, mitigates potential issues, and meets complex protocols. 

Designed to reduce common burdens, eCOA improves the overall study experience for sites, sponsors, and patients alike. With eCOA, you’ll gain better insight into the investigative treatment effects.  

About Signant Health:

Signant Health is the global evidence generation company. We help you modernize clinical trials by meeting patients where they are and reimagining the path to proof.

Product Description:

Clinical Trial Data Capture

The rise of remote patient trial participation is driving a greater need to adopt eSource technology. eSource enables sites, sponsors, and CROs to adapt and propel their clinical data capture technology, while meeting new expectations for patient centricity.

Leading the way to re-center Decentralized Clinical Trials (DCTs) by connecting data and operations, Clinical ink is the only company to deliver eSource solutions into a single clinical data platform supporting end-to-end clinical development.

eSource Technology and Solutions

Integrating Direct Data Capture (DDC) technology, eCOA, ePRO, and eConsent into workflows improves the capture, visibility, and management of data across devices, sensors, Televisit, and digital health technologies. This proven approach eliminates any need for heritage EDC systems fraught with delays and data inaccuracies due to paper, transcriptions errors, and SDV.

About Clinical Ink:
Clinical Ink, Inc. provides eSource solutions for the clinical trials industry. It offers SureSource, an electronic source solution that allows users to record comments, explanations, and validated source data on protocol-specific eSource documents, as well as captures the data required by the protocol. The company also provides an electronic source record (ESR) for clinical trials that provides cleaner data. In addition, it offers hosting services. Clinical Ink was founded in 2006 and is based in Winston-Salem, North Carolina.

Compatibility level

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Clients

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Use Cases

Description:

With Signant SmartSignals eCOA, you get so much more than advanced technology. You’ll gain access to Signant Health’s team of subject matter experts and data analysts who can help you navigate common trial complexities. Our industry-leading cyber security prevents your data from being compromised.

  • In-house scientific and clinical experts implement and develop instruments according to best practices.
  • Our proprietary design tool previews your custom COA as it’s being created.
  • We offer flexible deployment to support provision devices, the web, or a patient’s personal device (BYOD).
  • Our team of experts support you with scale licensing and management. 
  • Signant’s extensive eCOA library of scales ensures the quality, validity, and speed of implementation. This includes standard scales for oncology and other therapy areas, as well as computerized adaptive tests (CATs) using PROMIS CAT. 
  • Pre–configured eCOA packages accelerate deployment, while ensuring quality and cost efficiency.
  • Our unmatched global logistics skills help you manage device installation, inventory, and international shipments so that devices arrive ready on time in any country.
  • The complete audit trail provided permits authorized personnel to explore real-time data through interactive reports in just a few clicks.
  • Helpdesk representatives offer 24/7 support when it matters most.   
Pediatric use cases:

None provided

Users:

Not specified

Description:

Our Onsite eCOA and ePRO Tablets Offer:

Complete ALCOA Compliance

For full ALCOA compliance, our platform manages patient authentication with a unique PIN created by the patient at their first visit. When the patient completes activity, the PIN will provide a full audit trail with authentication detail and offer the ability to reset workflows without help desk intervention.

Patient Portability

Patient accounts created in our platform are fully portable across all tablets deployed to a site. Patients can complete questionnaires on any tablet assigned to a site, making schedule management easier for high-enrolling sites.

Patient Questionnaire Support

Patient visits involving multiple questionnaires can include workflow support to decrease patient burden and improve protocol compliance. Patients confirm their PIN and execute the first questionnaire, with all subsequent questionnaires launching as required by design, without additional monitoring.

Self Service DCFs & Questionnaire Query Support

Our onsite modules support remote monitoring and querying of questionnaire responses and tablet-based responses, allowing onsite users to see and respond to queries in context.

On-Device Training

We include onboard training solutions for easy patient and site coordinator-based eLearning and guidance. A guided practice study is available on all tablets.

Standard Reports Available Online

All of our onsite studies include a full set of standard reports

by default. These reports can be augmented by further

custom reports as needed or required.

Our Remote ePRO Solutions Offer:

Point and Click Mobile Solutions

Our remote solution is fully configurable. Project professionals are capable of designing, developing, and deploying functional prototypes for testing and review with minimal training.

In-App Patient Training Diary

The Training Diary includes all the standard ePRO Diary Controls. Once complete after the patient’s first visit, it will transmit to the study database with a record of patient training.

Compliance and Conditional Alerting via Email

Questionnaire compliance email-based alerts can be deployed to help sites and monitors proactively engage with patients to ensure compliance goals. Specific conditions to be tracked can trigger alert notifications via email to sites and monitors as needed.

Configurable Scoring and Coding

We simplify the process of scoring and coding for endpoint analysis, screening review, and randomization decisions, mitigating the complexity and setting up teams for success.

Fully Configurable and Sponsor-Specific Library

Our ePRO library supports the creation, locking and importing of questionnaires — meaning no need to repeatedly design, review, control, test, and UAT when deploying the same questionnaires in multiple trials.

Rapid and Regular Prototyping

Using the fully configurable authoring tool, project managers can rapidly design, configure, and deploy prototypes for sponsor and CRO design reviews and approvals, increasing efficiencies and feedback quality.

Standard Reports Online and On Demand

By default, all our deployments include a full set of standard reports. These can be augmented by further custom reports, as needed or required.

Support for All Clinical Trial Phases

Our platform has been deployed with major global pharma across all phases of clinical trials, with translation in more than 40 languages and the ability to support special character sets and right-to-left languages. The application is fully 21 CFR Part 11 and ALCOA compliant.

Support for Provisioned and BYOD

Our platform can be deployed to 1) manage device inventory, logistics planning, and patient device data plans for a provisioned model, 2) support a 100% bring your own device (BYOD) model, or 3) support a mix of both models. 

Pediatric use cases:

None provided

Users:

Not specified

EHR Integrations

Integrations:

None provided

EMR Integration & Relevant Hardware:

None provided

EMRs Supported:

None provided

Hardware Compatibility:

None provided

Integrations:

None provided

EMR Integration & Relevant Hardware:

None provided

EMRs Supported:

None provided

Hardware Compatibility:

None provided

Client Types

None provided
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Differentiators

Differentiators vs EHR Functionality:

None provided

Differentiators vs Competitors:

None provided

Differentiators vs EHR Functionality:

None provided

Differentiators vs Competitors:

None provided

Keywords

Images

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Company Details

Founded in 2006

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