Electronic Patient Reported Outcome (ePRO)

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ePRO – Electronic Patient Reported Outcome

As connectivity has improved and mobile technology has reached a level of user friendliness, putting patient at the center of the trial has not only become feasible but also real. ePRO is an approach in clinical trials to collect the attribute data from the patient directly (from the patient through mobile devices or web).

A medical care of the trial patient it is the responsibility of investigator. Most of time Patient not aware about his own safety in this case ePRO provide the complete information as improved and mobile technology tracking his/her daily function and benefit of the treatment of multicentre trial and different no of patient.

In Critical type of molecule or the complex study where the patient safety is more important than its results in that case ePRO Digital system gives more accurate and precious result like to mark the benefits and side effect as well as daily changes happen in the dosed patient he is always in touch with Investigator.

It is a completely 21 CRF part 11 compliant solution and integrates with clinical trial data captured in CRF.

Features:

More Care Should be Provided to Patient about their health

Instantly get the health related status of the patient in case of AE/SAE or in other medical emergency by the notification or alerts

Secure, audit-trailed enrollment of patients by investigating sites for participation in ePRO studies

Provides facility to design and implement electronic diaries

Designing of SRSC (Self Reporting Schedule Calendar) to attach ePRO form based on protocol which is automatically assigned to each enrolled patient

Notifications, Alerts and time limits can be set up for filling-up each ePRO form. Notification can be SMS, Email and/or In-App Notification

Each ePRO form can be uniquely designed to capture the required attributes

Notification can be sent to investigating site and site monitor as soon as ePRO form is submitted or not-submitted

Ability of the system to generate customized listing and export

Ability to report an event or attach photograph, audio from within app

ePRO monitoring window for investigating sites and monitors to manage and review status

Regulatory compliant, multi-functional Clinical trials management software solution for CROs

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