Mixed-Modality Deployment Compatible With Any Trial Design

Part I (of III)

Clinical Ink is continuously leveraging our experience and customer feedback to improve processes, enhance operational efficiency, and increase configurability so that our integrated Lunexis™ eSource platform continues to surpass client expectations. This three-blog series will explore some of our ongoing enhancements.

The needs of the clinical trial protocol — not the limitations of technology — should determine how a study is deployed. That said, until now, data collection technology has constrained data collection and review.

Leaving the rigid past behind

One of the long-standing issues with data collection has been that the entry modality — whether it’s a smartphone, a tablet, or a PC — is predetermined and fixed. If the trial began with patients using smartphones to enter their at-home ePRO data, that’s all they could use. If clinicians used provisioned tablets to enter ClinRO data from the exam room, they also had to use tablets to enter other data from their offices — they couldn’t switch to their PC, even though that might be more convenient. Sponsors would have to specify modalities ahead of time, and the ePRO and ClinRO platforms, once deployed, were unable to handle any variation.

This limitation is understandable, because building a single platform to unify multiple data capture modalities isn’t easy. To achieve this flexible, patient-driven design, we needed to make our system even more powerful and adaptable.

Easy implementation, optimal utility

Enter the latest Lunexis™ platform enhancements. We’ve worked out a solution to this problem, a way to unify data entered via any modality to suit any trial design. So now, with a single deployment, patients using Lunexis ePRO+ and site personnel using ePRO+, ClinRO+, or direct data capture (DDC), can select whichever data capture device is most convenient. Say they’re at home on the couch and start answering a questionnaire on their phone, but they get interrupted before they complete it. Then it’s time to go to work. Rather than abandoning the task for the day, they can switch and finish later at their workstation, if they want.

The same goes for clinicians, who might need to use a tablet for mobility at times but prefer to use their office PCs whenever possible. This flexibility is important to many people who know they are much more productive using one modality over another.

Mix-and-Match Optionality for Patients, Clinicians, and Sites


Enter data from multiple locations

The enhanced Lunexis eSource platform is also ideal for handling data being entered from variable locations — an especially important feature now that so many of us might remain at home through preference or because of isolation requirements. For instance, what would you do when a patient can’t come to the office but is due to complete an ePRO questionnaire normally presented to them on a tablet? With Lunexis ePRO+, they can still complete that questionnaire at home on their choice of device, and you won’t have missing data. This kind of optionality is also ideally suited to decentralized and traditional trials.

Refined by eight years and tens of thousands of user interactions

We are bringing out the best in ePRO, eCOA, ClinRO, DDC, and eConsent. It takes years of trials and client, patient, investigator, and other industry feedback to optimize these fit-for-purpose solutions. No other company can claim anywhere near this much experience.

Nor can they claim our pioneer status in BYOD: As part of a push to afford patients the ultimate convenience and flexibility, we recommend allowing them to use their own smartphones, whenever possible. Just a few of the advantages to this option are:

  • Time savings
  • Lower costs
  • Convenience for patients and sites
  • Better adherence

As the leader in BYOD, having experience with 15,000 patients in Phase I-IV+ trials, we can assure you that BYOD makes sense most of the time.

Want an Illustration?

In one Phase III clinical trial, 90% of the 275 enrolled subjects utilized their own phones to submit their data at 16 time points per day for three days, two weeks apart. Powered by a BYOD solution, the study achieved an astounding overall compliance rate of 98.3% with 86% of the subjects being 100% compliant.


And while 81% of Americans own their own smartphones, mixed-modality-capable enhanced Lunexis technology also easily accommodates provisioned phones for those who don’t.

The time when electronic data collection technology controlled how and where patients and clinicians could input data is over. Now, mixed-modality-capable eSource technology exists that can support any trial design with maximal patient and clinician optionality.

To learn what this means for eSource Patient Data Capture and Integration and how site and sponsor teams are able to view the data through further ongoing enhancements, read Part II.  

To learn more about patient and sponsor data integration, enhancements that allow integration with best-in-breed third-party systems, and the benefits of Clinical Ink therapeutic area-specific libraries, read Part III.

Topics: ePRO, eCOA

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