Empowerment Model: A Model to Efficiently Build eCOA Clinical Trials
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.
By digitizing approved home-grown and licensed questionnaires so they’re readily available for reuse, we help significantly reduce the study build timeline. What else can we do to make the study build go more smoothly? How can we help you get the most value from your internal and external resources? Those questions led us to a new service model.
We understand not every clinical trial needs direct data capture (DDC), eCOA, ePRO, and eConsent. And not every clinical trial sponsor or CRO needs full-service support from our team. In the name of providing adaptable solutions for an ever-changing clinical trial landscape, we now offer the Lunexis Empowerment Model.
The Empowerment Model is a first-of-its-kind approach that lets you subscribe to as much Lunexis as you need to build, manage, and run studies yourself — your data, your team, your way. No matter how much or how little technology and support you need, we remain your loyal partner through the duration of the study.
Designed to support traditional, hybrid, and fully decentralized trials, the Empowerment Model lets you fly solo with our source data capture technology or soar in tandem with Clinical Ink’s supportive expertise. No matter how you configure Lunexis, you access our pioneering technology with more freedom and control than ever before.
By empowering you to build your study your way, we simplify clinical trials even further by removing ourselves from some of the processes. By getting out of your way (but standing by to offer assistance when needed), you can launch your study even faster and save money.
Learn more about the Lunexis Empowerment Model.
Why Build an Empowerment Model eCOA Clinical Trial?
After conducting more than 300 studies in more than 70 countries, with nine known regulatory approvals, Clinical Ink has the depth and breadth of experience to help you run studies faster while delivering higher-quality data. Working with Clinical Ink through the Empowerment Model gives you the following perks:
Flexibility and control. Allow your internal SMEs to weigh in on study build for control over the process. Take control of your study with real-time data access.
Efficiency and speed. Decrease study startup time by building it yourself. We’re here for you, but you don’t have to wait on us to complete certain steps.
Cost savings. By subscribing to only the services and technology you need, you save on the cost typically required to use Lunexis.
Drive additional revenue. CROs can create new revenue streams by initiating ePRO, eCOA, and/or DDC. No more losing new business because you don’t have these services. And no need to acquire a technology company to implement eSource.
Data visibility and interoperability. Access clinical data immediately and keep it at your fingertips. Instead of asking us for a report, access that data directly to run your own reports and drive your own insights.
The Empowerment Model Process
The project life cycle and milestones remain the same whether you partner with Clinical Ink under the Empowerment Model or use the full scope of the Lunexis eSource Ecosystem. The way we support you, however, follows a three-stage process:
|Crawl: In the crawl phase, the sponsor or CRO shadows the Clinical Ink team while moving through the study design/build process.
This allows your team to absorb all the information required without needing to put it into practice right away. This shadow process is coupled with immersive in-app training on Lunexis.
|Walk: After completing a predetermined number of studies in the crawl phase, the sponsor or CRO starts walking. During the walk stage, our team shadows yours during the design/build process. We’re there to answer questions in real time while your team gets hands-on experience with Lunexis.|
|Run: Congratulations! You are fully self-sufficient in Lunexis. While you build your own studies, we’re here to advise when needed.|
The typical clinical trial life cycle. Clinical Ink is your partner from kickoff meeting through to closeout whether you choose the Empowerment Model or use the full scope of Lunexis.
Services and Support Available by Subscription
We configure our services and solutions to meet the needs of your study, from helpdesk support only to implementation of the full Lunexis eSource Ecosystem.
|eCOA, ePRO, and DDC Modules||Build/Configuration Work||Equipment Provisioning|
|BYOD Strategy||Quality Control/Testing||Tier 1 Helpdesk|
|Questionnaire Library||User Acceptance Testing (UAT)||Translations and Translation Support|
|In-Product Training||User and Site Management||Study-Specific Training Material Creation|
Ready to learn more about the Lunexis Empowerment Model?