For sponsors pondering how to establish or reconfigure a clinical trial disclosure team, there are many factors to take into consideration:
- Do we invest in third-party software or build it ourselves?
- Do we hire full-time employees?
- Do we outsource these functions?
- Do we want to fulfill just the mandatory regulatory requirements?
- Do we want to go above and beyond, setting an example for the industry?
- Or do we want to fall somewhere in between?
Of course, there is no single answer to these questions. The answer will be impacted by a range of variables, from size of the organization to number of trials annually, to location of trials (U.S. only or global) and more.
With the help of software and services, sponsors can expand their options. Sponsors struggling to maintain compliance can do so more efficiently. Those whose goal is to overachieve can turn such aspirations into reality.
While disclosure software significantly improves the disclosure process (think software vs. spreadsheet), it alone is not the be-all, end-all. And keep in mind that the FTE vs. software vs. contractors is not an either-or proposition. That is, no matter the size of the sponsor, at least one full-time employee (in some cases a part-time employee may suffice) is recommended, in addition to outsourcing tasks, in order to effectively manage the disclosure process.