On July 31st, 2020, The United States Department of Justice charged 8 individuals in a scheme to defraud the US Food and Drug administration and falsify records used in clinical research trials. The 19-count indictment provides a frightening insight into an allegedly callous and dangerous attempt to fraudulently present clinical outcomes in research studies. Central to the indictment is a fabrication and falsification of records related to the clinical studies under the defendants’ charge. Despite the myriad of clinical trial tools and software currently being utilized by clinical research organizations and sponsors the ability to misrepresent, mischaracterize, and simply misplaced data through email communications remains a very real risk.
Computerized systems are for the most part only as effective as the data they are provided with and by the way they are used and configured. It can be cost-prohibitive, especially for smaller contract research organizations to fully automate all of their CRO applications.
How Can our Clinical Trial Communication Tool Help?
promedim24’s trial communicator tool is unique in that it can create an immutable, auditable, secure, and integrous history of all study-related communications without the need for the entire study team to learn a new application or even have to log in.
The communication changes captured by the promedim24 application can then be reviewed by the investigator and are subject to a 21 CFR Part 11 electronic signature. Upon signing the communications history for the study, the data is then exported to a secure PDF that can be included as part of the electronic trial master file.
By simply establishing a process to ensure that all study communications are filtered through promedim24’s tool, sponsors, patients, and the CRO themselves can have full confidence as to the integrity of the clinical study being undertaken.
With promedim24 the possibility for fraud is greatly reduced. As well as its obvious application for data integrity, the clinical trial communication tool is also extremely useful for researching past decisions, understanding the genesis of decisions, and attributing key study influencing decisions in an immutable audit trailed time-stamped fashion.
The study communication module works best when it’s implemented on day one however it can be utilized at the beginning of all study phases and if there is an ongoing concern as to the appropriateness and cadence of study communications it can be introduced at any stage. If you have questions about our promedim24 study communication tool you can contact: [email protected]
