Our product, RealWorld EDC is a software application developed by our multi-disciplinary team. It is used to collect patient information for post-marketing surveillance studies. CTEP offers an end-to-end solution from eCRF design and build, to the delivery of a clean set of data. We work with clients in one of two ways:
- Providing RealWorld EDC directly to pharma and related sectors
- Partnering with Contract Research Organisations (CROs)
Our customers inspire our innovation
Since our inception we have listened to our customers & end-users and have continually innovated based on this feedback. We understand that doctors’ time, to collect patient data in the real world setting, is very limited and that no one study is the same. Therefore we have designed RealWorld EDC to be simple to use and provide study design flexibility to adapt the eCRF to fit study-specific requirements.
The process – from start to finish
CTEP offers an end-to-end solution from eCRF design to the delivery of a clean set of data.
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1 | Delivering a validated eCRF
Design: Customers simply provide their protocol to CTEP with any study-specific requirements. Our experts will interpret their study protocol and use it to generate a codebook for review (CRF). The CRF codebook illustrates how the eCRF will appear to the end-user. Once satisfied the eCRF is built in-house. Self-build is also available to clients who wish to build their own eCRF.
Validation: Once the eCRF has been built it will be available to review over the web. Clients will be asked to conduct user acceptance testing after which validation and system sign-off is completed.
Release: User set-up provides access to the live study via a study-specific URL.
2 | e-training
The system requires little training for users to become competent (15 minutes on average). Depending on the clients' study requirements there are varying training options. These include study specific online and e-learning programmes. Such programmes include a user certification function.
3 | Study & data monitoring
RealWorldEDC is designed with specific features which make remote study management more effective, including targeted source data verification (SDV). The Study dashboard is a single report which provides all key study data on one screen e.g. recruitment numbers, key dates, number of queries open and closed. It is available to all stakeholders including study management and data management.
4 | Helpdesk & support
All studies are monitored 24/7 by network monitoring and the CTEP IT team are always available to help. RealWorldEDC application facilitates communication between the doctor and the study monitor. With one click on an “Ask your CRA” feature the clinic can ask any question, which is emailed directly to the responsible monitor(s). This significantly reduces demands on helpdesk requirements.
5 | Hosting
The RealWorld EDC application is hosted in a highly secure international data centre in Dublin, Ireland. Other tenants include leading blue-chip international companies. This centre has state-of-the-art internal systems and SOPs to ensure the physical security of the data. CTEP, in turn, has its own SOPs that seamlessly interface with the data centres processes.
6 | Data Export
Data can be transferred on demand by a data manager, via the data migration module. The standard data formats are SAS compatible .csv or ODM.xml files. Other data formats can be accommodated on request and there is no dependency on CTEP personnel to access or transfer data.