To ensure the smooth transfer of data and interoperability, features such as APIs will be essential for electronic data capture systems and randomization tools. By condensing the number of platforms required by site staff, sponsors and site teams can relinquish some of their burdens while data freely flows across systems in a secure manner.

A non-negotiable requirement when it comes to eCOA platforms is strict adherence to global data protection regulations, including the General Data Protection Regulation and the Health Insurance Portability and Accountability Act, which are essential for maintaining patient trust and trial integrity. This is crucial in a time of ongoing cybersecurity threats. Quality benchmarks and standards set forth by regulatory bodies like the Food and Drug Administration have been established to safeguard data integrity and platform performance.


Laying the foundation for eCOA success
eCOA platforms are not just a steppingstone on the clinical trial trail, they are the guardrails that offer efficiency and patient engagement and ensure the quality of data. These approaches — patient centricity, agility, simplification of workflows and flawless integration — are all paths to streamlining trial processes and achieving better outcomes for all stakeholders. Through purposeful execution, these approaches serve not just the clinical trials they are part of, but the overall advancement of clinical research.

About the author: Melissa Mooney has over 19 years of experience in the development of eCOA solutions for use in clinical trials. Melissa’s area of expertise is eCOA solution design, where she has helped clients and eCOA vendors in develop robust and usable eCOA software solutions that meet eCOA protocol requirements. She also brings a plethora of experience in eCOA requirement gathering, leading eCOA User Acceptance Testing, eCOA data management and business development support.

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