ePRO

Our configurable authoring tool provides the flexibility and customization needed in a modern clinical trial. Support better patient reported outcomes with Clinical Ink’s Engage At-Home and On-Site application. The Engage At-Home ePRO solution improves patient experiences and data quality by integrating full-service digital patient engagement with a configurable point and click ePRO.

KEY BENEFITS

Delivers Complete ePRO Solutions Quickly and Without Programming

Move away from deploying costly custom-built ePRO software solutions that take too long to deploy and demand too much from your already busy study team. With Engage At-Home, ePRO solutions are configured using our advanced ePRO authoring tool, eliminating manual coding and enabling deployments with improved efficiency.

Point & Click Configurable ePRO

The Clinical Ink Engage ePRO solution for BYOD or provisioned smartphones is fully configurable. This means that when creating questionnaires or implementing existing questionnaires, project professionals with simple training are fully capable of designing, developing and deploying functional prototypes for testing and review. The configurable nature of the solution is based on a fully validated ePRO authoring tool, which has transitioned the standard questionnaire elements, such as multiple choice, yes and no, VAS, NRS, numeric entry and free text, into selectable control types. This significantly reduces unnecessary ePRO design complexity and makes the process more accessible and closer to the customer.

Fully Provisioned and BYOD Support Available

The Clinical Ink smartphone ePRO solution can be deployed using the Clinical Ink provisioned smartphone solution where Clinical Ink will manage the device inventory, shipping and shipment planning and device data plans for all your patients but can additionally support a 100% Bring Your Own Device (BYOD) solution where patients can use their own Android or Apple application compliant smartphone or, most commonly leveraged, a mixed mode of BYOD and provisioned use. Solutions for BYOD or provisioned use will be customized to fit the unique requirements of your study. Clinical Ink will review the protocol requirements and where requested provide expert guidance for questions involving equivalence, population smartphone adoption and risk of phase relative to the endpoints collected.

Compliance and Conditional Alerting via Email

Questionnaire compliance emails, SMS or phone notification-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.

True Collaboration in ePRO Design with Rapid & Regular Prototyping

With the fully configurable authoring tool behind them, Clinical Ink Project Managers can design, configure and deploy prototypes for sponsor and CRO design reviews and approvals rapidly and regularly. This rapid and regular prototyping approach decreases the cycle time spent on complex document reviews and improves both the degree of efficiency for, and quality of, the feedback involved with sponsors in ePRO design and approval. This process drastically improves the degree of collaboration between sponsors and Clinical Ink Project Managers for design, review and approval of screens and workflow. The enhanced collaboration moves UAT from a mysterious review for a final round of code to little more than a confirmation of the prototype just approved.

Configurable Scoring and Coding

One of the major areas of complexity in ePRO solutions today is the scoring and coding needs from questionnaires for endpoint analysis, screening review and randomization decisions. In keeping with the Clinical Ink Point and Click ePRO goal, these capabilities are fully configurable with validation beginning at the point of initial configuration.

All Clinical Trial Phases Supported

The point and click smartphone-based ePRO solution from Clinical Ink is fully Phase III ready and has been deployed with major pharma across all phases of clinical trials. The application is fully 21 CFR Part 11 and ALCOA compliant and has been deployed around the globe. With the global nature of the clinical trial space, our smartphone-based ePRO solution has been translated into over 40 languages and supports Latin-based character sets and special character sets (including simplified and traditional Chinese and Japanese), as well as right to left language requirements.

Routed in a Patient Engagement Foundation

Not as an afterthought or a separate solution but as a foundation, the Clinical Ink smartphone ePRO solution delivers meaningful and timely engagement capabilities to keep patients connected to the trials they’re in and at the critical time points they need to be. The Clinical Ink smartphone ePRO solution delivers patient engagement solutions purpose built to improve questionnaire compliance, visit attendance and medication adherence.

A CLOSER LOOK

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 in Clinical Ink’s ePRO offering. 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.

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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