Editor’s Note: This is the first of a multi-part series of Q&As featuring Clinical Ink executives. Given the company’s unprecedented growth over the past few years, as well as the tremendous growth opportunities ahead, we’re giving Clinical Ink clients and our team another way to get to know some of our newest executive members. Sign up for email announcements to get notified of upcoming “meet and greets!”

As pioneers in eSource, a technology that enables electronic data capture at its inception, we’re constantly looking for ways to streamline clinical trials and minimize the time it takes to launch them. By using our Lunexis™ eSource Ecosystem, our customers shave months off their timelines due to the near-elimination of source data verification (SDV) and the ability to access and analyze data in real time.

For infectious disease studies of any kind, the ability to accelerate trial timelines, while also providing high-quality data and reducing barriers to patient participation, is highly prized. And when the World Health Organization (WHO) declares a virus a pandemic, there’s no time to lose. Infectious disease drug developers must respond immediately to find treatment and prophylactic candidates and rapidly move them through the drug development process.

An Interview With Cogstate Neuropsychologist Robert McCue

CNS clinical outcome assessment — particularly performance-based outcome measures — are among the most complex and nuanced assessments in clinical trials. This complexity's potential impact on data quality and signal detection invites the innovative use of technology to streamline test administration and scoring, such as the use of advanced eCOA ecosystems paired with expert clinical scientific guidance to design workflows. This teamwork enables dramatic improvements in assessment data collection. The ultimate goals are more confident decision-making, more conclusive research, and faster delivery of new medicines to the patients who need them.

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 decentralized and traditional 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.

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.

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.

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.

Part I (of III)

Part II (of III)

Part III (of III)

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.

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.

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.

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? 

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?)

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?

Technology for decentralized 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?

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.

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.  

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.

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.