The Challenges with eSource
Our previous post illustrated some of the most significant benefits to operational effectiveness and efficiency in clinical trials by implementing eSource practices. These advantages speak for themselves. We also examined the regulatory support for eSource trials. Key regulatory agencies like the FDA have taken significant steps to remove barriers to their approval, and to detail the considerations eSource trials must take.
In this last piece we are going to cover some of the technical and institutional challenges that arise when shifting into eSource from traditional paper trials.
Technical Barriers
MAINTAINING AUDITABILITY – With the elimination of paper source records, the importance of ensuring that all data entry into the electronic system is clearly attributable to individual users in the system becomes paramount. The electronic system becomes the source document of concern.
VALIDATION OF ELECTRONIC SYSTEMS – Regulations require that electronic systems in clinical trials be fully validated to ensure accuracy, security, and reliability. Conducting this validation process can be a complex task requiring appropriate technology and human resources to ensure compliance.
DATA INTEGRITY – eSource eliminates transcription as a source of human data entry error, but it also introduces new possibility of error related to the system in use. New processes that deviate from the way clinicians have been collecting trial data historically is a risk and must be accounted for.
DATA SECURITY – Housing sensitive patient information in an electronic system carries with it the responsibility to protect that data. Encryption standards, physical database security, redundancy of servers, this task is complex and not one to be taken lightly.
Fortunately these technical issues are all covered by interfacing with a robust eClinical system. 21 CFR Part 11 compliance, which addresses many of these challenges requires systems like ours to have a thorough auditable record of all user activity within the system. Independent validation efforts by CRO’s and Sponsors are supported by our own internal validation practices and by third party audits of Security policies and the like. Lastly, the issue of data integrity is covered by core functionalities of the EDC. Users may be new to electronic data capture, but complex edit checks can ensure that data quality is not just sufficient but superior by evaluating the completeness and accuracy of data collected at the time of entry.
Institutional Barriers
ORGANIZATIONAL RESISTANCE – All organizations tend to resist change. This hurdle can be mitigated with a good understanding and communication of the benefits of eSource. The eClinical vendor your work with should be able to advise you on how best to approach this issue of organizational change and how best to communicate it to the rest of your team.
COST – Onboarding new technologies always carries with it new costs. The ROI of leveraging these powerful technologies, ultimately render them worthwhile. Fulling leveraging eClinical solutions with eSource trials reduces the overhead of data cleaning and data management, improves data quality, and streamlines interactions with regulatory authorities.
INTEGRATION EFFORTS – Working a new eClinical system into your organizations technological infrastructure can be daunting. Most modern systems however boast Open API’s that make these connections more intuitive. Integration challenges are also an opportunity to examine systems of process improvement. A robust eClinical system may, with a little work, be able to eliminate some of those peripheral technologies you’re thinking of integrating to maintain old workflows.
TRAINING & SUPPORT – Everyone internally needs adequate training and end-user support to transition smoothly into a new technology. A user-centric interface that is thoroughly documented should also be paired with detailed help documentation for self-guided learning, and a responsive team of support staff for direct assistance with issues.
The ability for an eClinical vendor to assist you with these institutional challenges depends more heavily on the quality of support they can provide than the technology they offer. If you are thinking about implementing an eSource trial, have these conversations with your vendor, and consider speaking with our experienced team here at Fountayn.