First steps when initiating the development of an eCRF system
So, you have been planning your clinical trial for quite some time. Protocol written and you’re now at the point where you need to decide on an Electronic Data Capture (EDC) system to adopt in order to collect the data throughout your trial. Often, if you choose a CRO to manage your trial, they have a portfolio of EDC providers they can recommend to you, although there are key things you should consider when choosing your EDC system:
- Cost implications
- Build time
- Responsiveness from the build team
- Can they meet all of your study build requirements?
- Responsiveness from the helpdesk team, once the study is live
Sometimes it’s easy to opt for the brand leaders because you have heard of them, probably know organisations who have used them before and trust that because they have competitive advantage, they are probably the best. This is often not the case. Depending on the requirements of your trial, a smaller EDC provider can provide a much more personalised experience with a dedicated team to guide you through the build process.
So I’ve chosen my EDC provider, what’s next?
At Datatrial, once a proposal has been accepted and all the contracts have been signed it is then over to our Technical Study Delivery (TSD) team. They will arrange an initial kick off meeting with the relevant people involved in the build. This is an opportunity to outline requirements, timelines, iron out any queries and answer any questions ready to start creating the Electronic Case Report Forms (eCRFs).
Things to have prepared ready for the initial meeting:
- Finalised protocol
- Any already prepared CRF’s
Datatrial suggest jointly setting and monitoring timelines during the kick off meeting to highlight key responsibilities throughout the build to ensure meeting the required go live date. We pride ourselves on the ability to offer an 8 week build time subject to all timelines being met.