For many types of medical device – 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.
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ePRO & eDiary: Direct Data Capture modules For Medical Device Clinical Trials
Realising the potential benefits of direct data capture for both pre and post marketing (PMS/PMCF) medical device investigations will require DDC software that ensures:
CRFWEB ePRO and eDiary tick all of these boxes, offering the most comprehensive and cost-effective DDC solution available on the market today for medical device manufacturers.
Direct Data Capture Options with CRFWEB
ePRO
CRFWEB 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 eDiary module, lend themselves especially well to decentralised and or hybrid trials and post-market studies.
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 questionniare, 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 Clindox App (available on IoS and Android).
eDiary
eDiary allows the sponsor/CRO to build a study for calendar-led ePRO to a pre-ordained schedule. This has obvious benefits from the trial creator’s perspective and in the medical device field there are obvious post-market as well as pre-market benefits.
eDiary allows greater interaction with the subject through login via mobile device for daily observations and improving data collection response through reminders and alerts. eDiary is accessed by subjects via a dedicated device provided by the Sponsor, or via their own device using the Clindox App.
Core functionality of our eDiary module
You can explore eDiary functions as they appear in the all new Clindox App, see our demo video below!
Your options for accessing eDiary & ePRO functionality: BYOD, PD and the Clindox App
Bring Your Own Device (BYOD) Model
Our BYOD model is fully integrated into the CRFWEB system. A study, or visit, is designated for patient-led entry in the design page, logins and passwords created, and the subject is then able to download the Clindox App from the Apple App Store for IOS users, or from the Google Play Store for Android users.
Provisioned Device (PD) Model
We recommend the world leaders in this field, Stefanini, as a supplier for Provisioned Device (PD) eDiary or ePRO services. They are world-leaders in the field and our relationship ensures seamless integration, but we are happy to work with the supplier of your choice.
The study is still designed and built using the CRFWEB eDiary or ePRO module and access is controlled via the supplied device.
We are able to offer the full functionality of ePRO and eDiary to our customers using either delivery model.
BYOD or PD – which is best?
A key decision to make is to choose the delivery mechanism for eDiary/ePRO. There are essentially two choices for any organisation if they are going down the route of patient reported outcomes… via Bring Your Own Device (BYOD) or via a Sponsor Provisioned Device (PD). As the names imply, BYOD involves the subject using their own phone/tablet. PD involves providing the subject with a device for the sole purpose of performing the study data entry.
There are advantages and disadvantages to both models. BYOD is obviously more convenient and significantly cheaper. PD has the benefit of pre-configuration to minimise the risk of subject non-conformity in terms of their device settings and compatibility. A general rule of thumb is that if a study requires frequent, relatively simple reporting, BYOD tends to have the advantage. Where reporting is less frequent and more complex, PD often has the greater merit, particularly if the cohort is small and geographically limited.
For a more in depth look at PD vs. BYOD, click here.
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