Written by Jessi Lanuza, Associate Director of Business Development
The word “eSource” is second only to “wearables” in buzz worthiness this year. Every top ten pharma I have spoken with has an eSource initiative or committee dedicated to studying eSource. But why? Is it necessary? Will it reduce timelines? Can eSource have a real effect on the bottom line? After all it was not that long ago that all that eSource is promising was being promised by another new idea, eDC. To answer the question, “Why use eSource?”. We must first ask, “Why not eDC?”. The answer is two-fold.
The advent of eDC delivered on the promise of ending the creation of volumes of paper records being delivered to a Sponsor for review and storage. eDC has also brought data into the digital age for analysis and decision making. However, although eDC helped reduce a lot of the paper issues for the Sponsor, it did not really end any of the paper issues for the sites. Site Investigators do not sit at a stationary desk all day, docked into a secure internet network. The reality is that eDC does nothing for the paper problem at a site. The site collects their data on paper and then transcribes into the eDC system at some point in the future. A CRA must come on site and verify the source data, which means sifting through those volumes of paper and raising queries, which the sites must then research and answer. All of this involves the access and use of paper.
So eDC fails to address the paper problem for the sites. Is that enough to throw it out? Maybe. Sites are important and can be hard to come by. Sponsors are always looking to remove barriers to enrollment. But the paper problem for sites affects the Sponsor in a different manner. While eDC does bring data into a digital format for analysis, it does it very slowly. It can take days or weeks for data to make its way from paper to eDC, then it must be verified by a CRA. Queries are raised and queries are answered and in the end 6,8, or even 10 weeks separate the time between when a patient is seen and when data is clean and ready for a Sponsor. This is the real failure of eDC. It has not gone far enough in speeding the access to data in a trial. This access can have serious consequences in determining patient eligibility, seeing safety signals, making decisions and ultimately bringing a treatment to market.
What will eSource do differently? True eSource will break a site’s bond with paper. It will eliminate the time lost between a patient visit and clean, verified data from that visit being available for decision making. This simple step will give:
- Investigators time back into their day that they can now spend with their patients
- Reduce the frequency and duration of visit by the CRAs, allowing them to focus on value-add activities rather than checking data transcriptions
- Solve the access problem for a Sponsor: make data available in real time
Can you imagine the transformation from traditional eDC data collection into eSource with an iPad? This is what we came up with…
Checkout the Why wait? video.