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ePRO

Get on the path to cleaner data and better insights for more confident decision-making with the configurable, fit-for-purpose Lumenis™ ePRO module. Our configurable authoring tool provides the flexibility and customization needed in a modern clinical trial and supports better patient-reported outcomes. The Lumenis ePRO module solution improves patient experiences and data quality by integrating full-service digital patient engagement with a configurable point-and-click ePRO spanning multiple therapeutic areas.

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 Lumenis, we configure ePRO solutions, eliminate manual coding, and enable deployment with improved efficiency.

Point & Click Configurable ePRO

The Lumenis ePRO solution for Bring Your Own Device (BYOD) or provisioned smartphones is fully configurable, allowing for the creation of 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 flexibility significantly reduces unnecessary ePRO design complexity.

Fully Provisioned and BYOD Support Available

You can deploy Lumenis using a provisioned smartphone solution (including device inventory management, shipping and shipment planning, and device data plans for all your patients): a full BYOD solution where patients can use their own smartphone or a mixed mode of BYOD and provisioned use. Our support specialists 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

To help sites and monitors proactively engage with their patients to ensure compliance goals, Lumenis can deploy questionnaire compliance emails, SMS, or phone notification-based alerts. 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, our project managers can design, configure, and deploy prototypes for sponsor and CRO design reviews and approvals rapidly and regularly. This 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 project managers. The enhanced collaboration changes user acceptance testing (UAT) from a mysterious review of a final round of code to little more than a confirmation of the prototype just approved.

Configurable Scoring and Coding

Scoring and coding needs from questionnaires for endpoint analysis, screening review, and randomization decisions are fully configurable with validation beginning at the point of initial configuration.

All Clinical Trial Phases Supported

The Lumenis ePRO module is fully Phase III ready and 21 CFR Part 11 and ALCOA compliant. We have deployed it with major pharma across all phases of clinical trials and around the globe. The smartphone-based ePRO solution is 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.

Rooted 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 are in, at the critical time points they most need to be. Lumenis is purpose-built to improve questionnaire compliance, visit attendance, and medication adherence.

A CLOSER LOOK

In-App Patient Training Diary

In Clinical Ink’s ePRO offering, we include an In-App Patient Training Diary designed for completion by patients at the first visit and with site coordinators. The Training Diary includes all the standard ePRO Diary Controls. Once complete, the Training Diary will transmit to the study database with a record of patient training.

Fully Configurable and Sponsor-Specific Library

Lumenis 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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