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Whitepaper

Phase 1 Clinical Trials and ePRO:

The Time is Now

Download this free whitepaper to learn how Clinical Ink’s ePRO technology, Engage, brings a timely, easy-to-implement, cost-effective solution to Phase 1 studies.

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This free whitepaper will demonstrate how Clinical Ink’s ePRO technology, Engage, can solve long-standing issues with paper-based Phase I clinical trials, including the lack of data attributability, the inability to monitor patient activity in real-time and the time it takes to transcribe subject reported data into an ECF.

Read this whitepaper to learn how Engage revolutionizes Phase I trials with:

  • Timely, quality results that save on study budgets
  • A tested BYOD option
  • An ePRO library with re-usable questionnaires
  • Better, cleaner data with a back-end database
  • Agile project management and software configuration methodology

Features of ePro for Phase 1 Clinical Studies

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Point and Click Smartphone ePRO Solutions
Clinical Ink’s Engage, the at-home ePRO solution for BYOD or provisioned smartphones is fully configurable. Therefore, project professionals are fully capable of designing, developing and deploying functional prototypes for testing and review with minimal training.
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Rapid and Regular Prototyping in ePRO Design
 Using the fully configurable authoring tool, our project managers can rapidly design, configure and deploy prototypes for sponsor and CRO design reviews and approvals. This rapid and regular prototyping increases efficiencies and the quality of feedback provided on complex documents.
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Fully Configurable and Sponsor-Specific Library
Engage is supported by a configurable, full-service ePRO library. No longer will you need to repeatedly design, review, control, test and UAT when deploying the same questionnaires in multiple trials. The ePRO library supports the creation, locking and importing of questionnaires.
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Configurable Scoring and Coding
Engage greatly simplifies the process of scoring and coding for endpoint analysis, screening review and randomization decisions, each of which are critical sources of complexity in ePRO solutions today.
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Fully Provisioned and BYOD Support
Engage is fully Phase III ready and has been deployed with major pharma across all phases of clinical trials and around the globe, 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.
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All Clinical Trial Phases Supported
Engage greatly simplifies the process of scoring and coding for endpoint analysis, screening review and randomization decisions, each of which are critical sources of complexity in ePRO solutions today.
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In-App Patient Training Diary
An In-App Patient Training Diary designed for completion by patients at the first visit and with site coordinators is included. The Training Diary includes all the standard ePRO Diary Controls, and once complete, the Training Diary will transmit to the study database with a record of patient training.
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Compliance and Conditional Alerting via Email
Questionnaire compliance email-based alerts can be deployed to help sites and monitors proactively engage with their patients to ensure compliance goals. Specific conditions you need tracked can trigger alert notifications via email to sites and monitors as needed.
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Standard Reports Available Online and On-Demand
All Engage deployments include a full set of standard reports by default. These reports can be augmented by further custom reports as needed or required.

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Clinical Ink’s Esource Platform

Clinical Ink’s eSource platform supports the full range of validated ePRO questionnaires and eCOA-based CliniROs, ObsROs, PerfOs and Structured Diagnostic Interviews for both site- and home-based settings. The platform provides complete support for protocol requirements, offers regularly scheduled data transfers and has been deployed for use in all phases of clinical trials and across a wide range of therapeutic areas. Clinical Ink University also provides full-service training by web or at your site

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eSource Benefits

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Delivering the results you care about in the most effective way
Clinical Ink is transforming the clinical trial experience with an end-to-end eSource platform, purpose-built to deliver better results. With solutions such as EDC replacement, eCOA, ePRO and more that capture data in the moment and communicate with one another, we’re able to impact the study protocol and drive efficiencies in ways that no other platform can. Without complexity, you’re able to more effectively get what you need from your technology: compliant, quality results.
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Bringing you to the next stage of clinical development faster
Everyone knows that time is of the essence in clinical trials, yet Clinical Ink’s eSource platform is the first to radically accelerate time to value. From quick and configurable study builds to real-time data capture and availability that compresses the time it takes to complete common tasks, we’re stripping away inefficiencies to improve the relationship between time and cost— knowing that the faster you move through the clinical development process, the sooner new treatments will be brought to market.
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Connecting you to the future of clinical trial technology today
In an age of dramatic simplification and streamlined business models, clinical trials is the exception. Clinical Ink’s proven eSource platform was designed by visionaries who recognized the need for a better clinical trial experience. Now thousands of users in more than 60 countries are using our platform to compress trial time and optimize costs with faster study builds, same-day form fills and more, all while positioning their organizations at the forefront of clinical trials.

About Clinical Ink

Clinical Ink, a global clinical technology company, offers data certainty from source to submission. Our eSource clinical technology and configurable ePRO and eCOA modules — a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source — naturally enhance your clinical trial workflow by reducing manual labor, providing anytime, anywhere data access, and saving resources as your trials progress. Accelerate the completion of key clinical development milestones in your study and confidently manage your trial’s critical decisions with our flexible menu of collaborative services, remote monitoring support, and a complete, real-time view of your trial.   

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Contact Us 1.800.301.5033