In the last decade, many clinical trial sponsors have shown keen interest in transitioning from paper to e-source to further strengthen the model of decentralized clinical trials. But even a decade later, the adoption has been slow and requires clinical trial organizers to accelerate the process by eliminating the limitations.
The good news is that with more and more clinical researchers moving to e-sources, there has been an upward trajectory in the development of technology that facilitates modernized clinical trials. So if your company has been considering making a transition from paper to e-source, keeping the following considerations in view, you can successfully accomplish your goals.
What is E-Source in Clinical Trials?
E-source in clinical trials refers to the electronic data capture, such as electronic patient record outcome (ePRO). Clinical researchers keen to adopt decentralized clinical trials in recent years have moved to EDC to digitize their data entry, data management, and data analysis by using various technology tools at their disposal.
Considerations When Transitioning from Paper to E-Source
For clinical trial sponsors such as pharmaceuticals, the transition from paper to e-source has an abundance of benefits. However, these benefits can only be leveraged when you bear in mind the following factors.
Compliance Guidelines
The US Food and Drug Authority has published a comprehensive industry guideline for sponsors seeking to transition from paper to e-source. Make sure you’re fully aware of the compliance and standards set by FDA and adhere to those when conducting your clinical trial digitally.
Standardization of Processes
To make sure that your transition from paper to e-source is validated and fits the protocol criteria, standardization of processes is essential. This means that clinical trial organizers must implement SOPs, assessment flows, and a predefined model for the completion of electronic data capture.
Upskilling and Culture of Innovation
The adoption of e-sources has been comparatively slower owing to limitations for upskilling and innovative tools. By nurturing the need for upskilling clinical researchers and promoting innovation in your organizations, you can accelerate the process of e-source adoption.
The Need for Right EDC Systems
Lastly, all decentralized trials and e-sources depend on robust EDC software. Make sure to invest in an EDC system that fully caters to your clinical data management needs.
Transition From Paper to E-Source with Clinical Pursuit
If you seek to transition from paper to e-source, then reach out to us at Clinical Pursuit. Our clinical data management solution helps with electronic data capture, remote monitoring, and e-source data verification. Book a free demo here to learn more.https://clinicalpursuit.com
