ePro: Direct Data Capture Modules For Medical Devices Clinical Trials

How Epro provide excellent results to enhance clinical trials
For many types of medical devices – particularly those at the lower end of the risk scale, Direct Data Capture from subjects in their home setting (DDC, also often referred to as eSource) can provide more meaningful and comprehensive real-world data from a broader cohort of subjects. Studies based on this methodology are known as decentralized clinical trials (DCTs) and these can often be lower in overall cost and complexity.

Understand How MILO Direct Data Capture Can Elevate Your Clinical Trail Experience

MILO features a fully integrated ePRO (electronic patient reported outcome) interface, where subjects can answer questionnaires without risk of accessing other functionality or data.

A study can be designed to be entirely ePRO. It’s also possible for a particular visit within a study to be designed as ePRO, giving ultimate flexibility in study design. With data entry by the subject, both ePRO and the complimentary eConsent module, lend themselves especially well to decentralized and or hybrid trials and post-market studies.

Enhance your studies with ePRO

Welcome to MILO DCT, your platform for designing personalized clinical studies with unmatched autonomy. Create studies efficiently while utilizing decentralized solutions, especially electronic Patient-Reported Outcomes (ePRO), for enhanced data collection, management, and patient engagement.

Realizing the potential benefits of MILO ePRO for both pre and post-marketing in medical device investigations:

• Compliance with all relevant FDA, MDR, and GDPR requirements.• Ease of use for subject.
• Operational equivalence across all likely mobile devices.
• Full access to the feature set underlying MILO platforms.
• real-time patient data collection.
• user-friendly design.

These are some of many benefits brought by using our Platform. MILO ePro isn’t just a tool; it’s a game-changer for clinical trials.

How to report the outcomes of the patients?

Patient engagement is pivotal to the success of any clinical study. MILO’s ePro approach emphasizes user-friendly design. Patients submit their results on the MILO DCT app with simplicity and intuitiveness while ensuring the security of their data.

There are two ways in which the patient can directly report outcomes via ePRO. Firstly, subjects can report during a site visit where staff can easily initiate a subject session to allow them to complete a questionnaire, or the subject can log in from home with a unique username and password. If the subject is reporting from home, they might be using a dedicated device supplied by the Sponsor or they may be using their own device loaded with the MILO APP (available on IoS and Android).

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