eISF Reference Model: The Case For Standardization

By Bree Burks, RN, MSN and Todd Tullis

Clinical research sites face a growing number of regulatory, technical, and administrative hurdles associated with maintaining compliance. The largest contributor is the increased scale and complexity of the modern protocol. Where once a study site conducted few, mostly static, protocols, today’s protocols evolve based on real-time data and bring together multiple specialized stakeholders across time zones and continents.

From this growth in complexity, the ability to produce documentation detailed enough to enable both the conduct of a clinical study and the quality of the data produced to be evaluated has overwhelmed regulators, sponsors, and, most of all, research sites. Standardization represents a significant opportunity to improve record-keeping and simplify compliance at clinical trial sites.

Veeva believes an international, comprehensive eISF standard will allow research sites to better meet their regulatory obligations by freeing up precious resources and returning a site’s focus to what is most important: the thoughtful care of patients and the production of knowledge that heals.