New remote monitoring platform fulfills FDA's guidance on remote, central and risk-based monitoring

The ROMaN Project, Inc. announces its endorsement of the Food and Drug Administration's (FDA) guidance to utilize risk-based monitoring in clinical trials. Risk-based monitoring focuses attention to the most critical data elements in a study and allocates monitoring resources to the investigator sites with problematic or unproven protocol compliance and/or data integrity.

The ROMaN Project's LORACIS™ is the first comprehensive remote monitoring platform available for the clinical trials industry, and is designed to fulfill the FDA's guidance on remote, central and risk-based monitoring. With this platform, sponsors and contract research organizations (CROs) can now verify study data and compliance remotely using a centralized database of redacted and certified source documents.

"Risk-based monitoring, including the appropriate use of centralized monitoring and reliance on technological advances can meet statutory and regulatory requirements," according to the FDA's recent statement, Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (FDA, August 2013.) "Incorporation of centralized monitoring practices, where appropriate, should improve a sponsor's ability to ensure the quality of clinical trial data."

Employing monitoring strategies away from the study sites requires a secure central repository containing the study patients' records and important study documents. Although not all centralized monitoring has to be remote (off-site), and not all remote monitoring must use a centralized repository of records; the two terms are usually interchangeable.

Centralized monitoring processes can provide many of the capabilities of on-site monitoring.  "We can ensure that the processes and expectations for site record keeping, data entry and reporting are well defined. Plus, our remote monitoring platform can support rapid access to clinical trial data and documentation from anywhere in the world," states Bruce Ross, The ROMaN Project's chairman and CEO.

At the study site, study personnel use LORACIS™ to process any paper or electronic study document; and in this one step, documents are instantly redacted, certified and uploaded to a secure central repository. Its web portal can be viewed across the globe with a standard Internet browser, allowing sponsors and CROs to quickly verify study data and ensure protocol compliance, thereby eliminating unnecessary travel to each study site. Because each hour of travel time saved by remote monitoring is an hour gained of productive monitoring time, the reduction in travel time and expenses result in significant cost savings.

The FDA believes that verification of study subjects' informed consent is a critical activity that should be monitored. "This is of most importance because LORACIS™ was designed from the first keystroke to allow the remote verification of consent forms," says Ross.