eSource DDC

The eSource Ecosystem: Making Virtual, Hybrid, and BYOD Trials Your Reality

By now, it should be clear to everyone that hybrid trials are here to stay. Our customers are seeing the benefits, and now others are taking notice.

But what defines these trials? And what are the best practices and best resources to really make them work?

The foundation is eSource – more specifically, direct data capture (DDC), as opposed to EDC. From complicated ClinROs to BYOD, Clinical Ink has pioneered and set the bar for virtual and hybrid trials, and I can tell you that it takes a thoroughly proven, tightly integrated technology toolkit to coordinate all the disparate tasks involved in these trials.

This blog explains what DDC is and how it’s really the only methodology that will afford you the flexibility, speed, site efficiency, and data quality you need to make your trials successful.

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ePRO / BYOD

Go Where Your Patients Are. GO BYOD. How to Launch a Successful BYOD Strategy in Any Phase

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

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Comply With the New EMA CT-C19 Remote Source Data Verification (rSDV) Guidance

And Avoid Undue Burden on Patients and Sites

On February 4, 2021, the European Medicines Agency (EMA) issued CT-C19 guidance v4, an update on the management of clinical trials during the COVID-19 pandemic. Given the impact of COVID-19 on clinical trials and participants, the guidance acknowledges that standard clinical trial conduct may need to be adjusted to enable research to continue.

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Oncology / ePRO / eCOA

Agile Lunexis™ ePRO+ Methodology: Eliminating Barriers to Cancer Research

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ePRO / eCOA

Sponsor and CRO’s Choice: Holistic On-Site, At-Home, and Virtual eSource Flexibility for Clinical Trials

Sometimes, it seems like your trial needs to tiptoe around what your technology can and can’t do. It doesn’t have to be that way.

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ePRO / eCOA

Mixed-Modality Deployment Compatible With Any Trial Design

Part I (of III)

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ePRO / eCOA

A Unified Experience in eSource Patient Data Capture and Integration for Sites and Sponsors

Part II (of III)

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ePRO / eCOA

One Patient Data Capture Application That’s Everything to Everyone: The Evolution of Lunexis™ ePRO+

Part III (of III)

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ePRO / eCOA / CNS

Making Data Central to Your CNS and Pain Trials: A Therapeutic-Area-Specific Approach to Data Capture Solutions

A year or two ago, the team at Clinical Ink noticed a lot of growth in CNS and pain trials. These trials are demanding from a data capture standpoint: complicated eligibility criteria, extensive monitoring requirements, comprehensive data collection, and substantial demands on patients all must be overcome.

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eSource DDC

DDC vs. EDC: Frequently Asked Questions

Direct data capture (DDC) and electronic data capture (EDC). They sound the same. But when you dig a little deeper, there are fundamental, crucial distinctions that make a significant difference in clinical research workflows, data quality, and timelines. Here, we briefly cover the differences (for greater detail, read eSource: 6 Steps to Understanding) and answer some of the biggest questions we get about DDC from clients.

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Gastrointestinal / ePRO / eCOA

Handling Complexity in GI Trials ⁠— a Purpose-Built eCOA/ePRO Solution: The GI Library

The accelerating complexity of gastroenterology protocols has exceeded the capacity of most electronic clinical outcome assessments (eCOAs) — including both electronic patient-reported outcomes (ePROs) and clinician-reported outcomes (ClinROs) — to adapt. Patients are overwhelmed, sites are overburdened, and sponsors struggle with data quality and integrity.

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Lupus / eCOA

Lupus Studies Deserve a Better Approach

Challenges such as outdated data processes, ineffective study design, and lack of understanding can create obstacles in clinical studies around complex diseases like systemic lupus erythematosus (SLE). How can sites and sponsors harness advanced data capture practices to overcome challenges faced in SLE trials? 

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Lupus / eCOA

Happy Site, Happy Life: Illuminate the Path to a Brighter Future for Lupus Research by Easing Site Workflows

Traditionally, convenience of protocol execution for sites has not been a major factor in clinical trial design. But you have to wonder why, given that sponsors depend on sites to properly perform the exacting, daily work of patient management and data collection. Common sense dictates that considering site workflows and providing tools that support effective protocol execution would benefit all stakeholders by easing the burden on sites while reducing errors and producing higher quality data. One such consideration is systems that allow sites to capture data electronically, during the patient visit. According to a survey by the Society for Clinical Research Sites, 79% of sites found it helpful to record data in a direct data capture (DDC) solution. (2017, Why Is Clinical Source Data Still Collected on Paper?)

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ePRO / eCOA / eSource DDC / eConsent / Infectious Disease

A Virtual Answer to the Paradox of Clinical Research in a World of Contagion: Advanced Logistics and Data Capture for Rapid, Cost-Effective Infectious Disease Research

When we think about clinical research innovation, we usually focus on the science. What is our inspired hypothesis, and how are we going to prove or disprove it?

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ePRO / eCOA / eSource DDC / eConsent / Infectious Disease

Will Coronavirus Force New Wave of Technology Adoption in Clinical Trials?

Technology for virtual trials, bring your own device (BYOD) ePRO, and direct data capture (DDC) have been in place for several years, but the implementation of these hybrid approaches has stagnated. While cleaner data, reduced cost, and patient engagement are all benefits of hybrid study implementations, unfortunately, perhaps the biggest accelerator to their wider adoption will be the COVID-19 pandemic. With cancellations increasing daily, and people avoiding gathering places (especially doctor’s offices), the practicality of hybrid trials stands out and leaves the industry to question – will the Coronavirus force a new wave of technology adoption in clinical trials?

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eSource DDC

eSource: 6 Steps to Understanding

There’s a lot of confusion surrounding eSource. What is it? How is it used? What’s wrong with the way I’ve been recording my data since 2007? Here, we aim to clear the muddied waters.

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eSource DDC

EMA Support of eSource in Clinical Trials Signals Upcoming Industry Shift

The European Medicines Agency (EMA) indicated that it supports the use of eSource direct data capture (DDC) in clinical trials. Its qualification opinion, released in September 2019, states that eSource DDC that is implemented correctly and compliant with Good Clinical Practice (GCP) can be used in support of regulatory filings. This has important ramifications for sponsors, CROs, and the industry as a whole.  

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ePRO / BYOD

The Future Is Here: Patients, Sites, and Sponsors Are Benefiting From BYOD ePRO Clinical Trials

For years, the idea that electronic patient-reported outcome (ePRO) tools deployed on a patients’ own device could streamline data collection for clinical research has been considered just beyond the industry’s reach. Many believed bring-your-own-device (BYOD) strategies, where patients use their own devices to collect data within the context of a clinical trial, were not a worthwhile investment.

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Lupus / eCOA

eLAS® — Changing the Landscape of Lupus Clinical Trials

What do you do when a well-known CRO comes to you for a data capture solution for not just one clinical trial, but for studies throughout that entire therapeutic area? You build a customized platform that increases efficiency, improves data accuracy, and can be customized to work across all clinical trials in that therapeutic area.

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