3 Questions to ask eSource vendors
Written by Jessi Lanuza, Associate Director, Business Development
In a previous article I have discussed Why eSource? The answer is clear. The demand for real time data in clinical trials continues to grow because of the need for faster access to safety signals, faster access to decision making data, such as patient eligibility and dose escalation, faster access to efficacy data. And what does this speed ultimately provide? Not only can the industry get lifesaving products to the patient sooner, money can be saved during the process. Too good to be true? Not at all.
eSource systems are delivering on the promises made by EDC many years ago. Data is entered directly into the system in front of the patient, reviewed and made available to the sponsor for decision making in less than 50% of the time it takes with EDC. Large portions of eCRF data can be reviewed/ verified remotely, allowing for fewer on site CRA visits and more CRA time spent on site management and developing strong relationships. However, not all eSource providers are created equal. So what questions should you be asking vendors to ensure that you are getting all the benefits of eSource?
1. Is the system fully functional offline? There is only one way to accomplish eSource. Correct data must be entered while in front of the patient. No paper can be used, otherwise, the paper becomes the source. Therefore, offline functionality is essential given the sporadic and unreliable nature of internet connectivity in many large hospitals.
2. How does it scale? In discussions with a Top 10 Pharmaceutical Company, I learned that although they were early adopters of eSource, they are considering moving away from it all together. What is their main issue? Scalability. They are overwhelmed with distributing, inventorying, and collecting multiple hardware devices in large trials. Deployment of eSource solutions has to be simple, cost-effective and efficient; particularly for global, multi-center studies.
3. Can sites collect data for their internal source forms? There will always be data, outside the eCRF, that the site must collect at the time of visit. eSource systems must be able to collect this non-CRF data in order to render paper obsolete.
So, go eSource! Do it now! The market is maturing and there are great systems out there. The effort to change is worth it! Just ask the questions to make sure that the eSource you choose is the right eSource for your organization.