ISI is attempting to kill two regulatory automation birds with one stone: ISIRegTracker version 4.2, part of its Regulatory Information Management system. The system encompasses portfolio management, registration tracking, submission management, and publishing tracking and automation.
The first bird ISI is targeting is poor data and data misalignment with corporate goals and processes. ISI says the intent of the release is to improve the quality and reliability of the data being entered into the system; to get actionable information into the hands of decision-makers; and to improve data sharing. Version 4.2 incorporates the DIA's EDM Reference Model, which provides a reference model for shareable document management repositories.
The second bird is system ineffectiveness. ISI calls the product a "consulting-led solution," meaning it's implemented by the company's regulatory specialists rather than implementation engineers, Lisa Meyer, global marketing director at ISI, explains. "ISI has formulated a strategy for the product and developed services to help ensure successful implementation."
System implementations often fail, she says, because users have only a poor understanding of the system and its benefits. So they don't accept it. "Through an implementation that has our regulatory consultants leading, we're assured of dealing with the issues that our clients and others have highlighted as huge," says Meyer.
There is also a business intelligence angle to the ISIRegTracker. Many drug development companies seek automation for portfolio, submission, and registration management tasks, as we've reported. Most currently rely on homegrown and outdated systems, says Meyer.
A version 4.2 objective is to help user companies "gain a total picture of product portfolios for streamlined decision-making. New functionality helps deliver more reliable intelligence for executive, strategic and operational teams."
- here's the announcement