Clinical trials are conducted on a wide variety of software platforms to collect the data in a meaningful and accurate way. But before using these systems to build and conduct studies, the first question to arise always tends to be, “is the system validated?”
The answer to that by any software vendor will inevitably be “yes.” And rightly so. Validated software is a relative term based on selected guidelines. There are no official rules in place by any governing organization or authority that defines what “validated software” looks like. The FDA, being the foremost U.S. authority on regulation, has provided guidance and good practices which software should follow. However, even the best of software practices may still result in a product that does not comply with rules of study regulation, such as 21 CFR Part 11.
When looking for software to build and conduct studies, the first question to ask is, “Does the software allow for studies to be designed in such a way that the data follows compliance rules?” Any good software vendor will be able to provide a list of compliance rules and refer to how those are followed. If you have a regulatory expert at your organization, they should be able to spend as little as an hour on the software with the vendor and see first hand how selected compliance rules are followed. Once you’re comfortable with compliance, you’ve accomplished the most important step. After all, those are the only rules you have to go by.
The secondary question to ask the vendor is then, “How will your software practices provide confidence that the system will remain compliant?” This is where everything is up to interpretation. There is no official checklist of rules. Even the FDA’s guidance is only just that and should not be the end-all determination of the best system for your organization’s best interests. This should be a primary focus when auditing a system. Use that time to be sure you are comfortable with the vendor’s internal development practices. If you have your own IT personnel or programmers, consider involving them in the audit, to be sure everyone is confident with the tools.
The final important element is the functionality the software will provide. Does the software make your studies more accurate, more efficient, and save you overwhelming expense? If the answer is yes to all three of those, you likely have a winner.
The team at Crucial Data Solutions will never say, “Yes, our software is validated.” Nobody can say that with real meaning behind it. At Crucial Data Solutions, what we can say is, after 19 full-scale audits of TrialKit so far, by all 19 different definitions and many more successful studies, TrialKit is validated. Contact us today to discuss TrialKit’s fit for your clinical trials.
