ePRO – Electronic Patient Reported Outcomes

VISION’s ePRO capability allows patient reported outcomes to be directly and securely entered into the EDC system in a 21 CFR compliant manner. This reduces the potential for transcription errors and allows for more timely data review and monitoring – both of which increase the quality of study data and eliminates most source document verification requirement.

Once the patient is given access they can interact with the EDC via any browser on any internet-capable device.  Based on your specifications, the patient can have as little or as much access to eCRFs as the study requires.  VISION™’s ePRO provides the capability of direct data-entry by the patient, at the source of the data. Whether it is a dosing timeline, patient diary, questionnaire or a multitude of VAS scales, any patient with internet access can securely sign in and enter their data. This type of data-entry can be performed at the clinic with the doctor’s supervision or from the comfort of their home. And because their access to forms is typically limited, training is not as intensive and often not even necessary.

As big data becomes ubiquitous and mobile internet-ready devices more mainstream, patients are finding it simple and often preferable to take control when sharing their medical info.  This results in data being contemporaneous, allowing monitoring and reporting to happen in real-time.

Prelude provides you secure browser-based logon regardless of your study role or access permissions. That means the same encryption that secures your logon is also securing patient logon. From a home computer to a tablet or smart phone and smart wearables, VISION allows freedom for patients to connect quickly and easily to document their data. In turn, you can rest easy knowing patient access is secure, their data entry valid and that you are provided with real-time insights into patient reported data.

VISION™ Extension // contracted per study