Even the ‘Feds’ are getting in on the SharePoint act. Well, maybe not directly as yet, but the regulation of drugs and medical appliances by the Food and Drugs Administration (FDA) has become so complicated and the documentation involved so stringent, that NextDocs has had to produce a major upgrade to its MOSS-based software suite.
Version 3.5 of the NextDocs Regulatory Document Management(RDM) system includes an entirely new module for managing clinical documents as well as new features that enhance users’ ability to easily manage regulated content.
In truth, the new product was first unveiled in the US at the beginning of February, but it has been on tour since and has had its first major European outing recently at the DIA 21st Annual EuroMeeting in Berlin, Germany.
Following FDA Requirements
This latest module on the SharePoint Server-based document and quality management solution for life sciences companies contains a complete set of features that addresses all current FDA regulatory requirements for drug and medical licensing applications, as well as a complete life-cycle tracking of the countless documents required during the regulatory process.
Ready to deploy from the word go, NextDocs says it is, to all intents and purposes, “Built in SharePoint” with potentially higher adoption rates industry-wide, while at the same time providing a significantly faster, and user-friendly system.
Browser Based Module
Browser-based, and completely integrated into the SharePoint platform, the company says it operates using the MOSS 2007 interface and extends the platform rather than replaces existing functions.
By enforcing consistent folder structures, naming conventions and hierarchies, the RDM also has a Microsoft Word facility to develop templates for documents that require hard-copies for the submission process.
This Word facility also includes the ability to conduct parallel reviews as well as ability to launch workflow and lifecycle processes directly from Word.
While there are already a number of other submission management systems on the market at the moment, NextDocs says V3.5 allows for seamless integration with these products being provided by companies like Liquent, ISI, Dataform and Extedo.
Easy-To-Manage Drug Applications
In effect, what this latest module does is to allow for the collaboration and document sharing of information between the co-sponsors of a given medical application, including investigators, site monitors and vendors.
It tracks all processes, both mandatory and discretionary related to the particular application, as well as documentation of trial products and protocols.
“The Clinical Module is a major extension of our product’s capabilities to a new set of business processes,” Zikria Syed, CEO of NextDocs said.
“By utilizing SharePoint Server, we can provide both a collaborative portal for study participants and a fully compliant document repository for regulated documents.”
With drug regulation becoming ever tighter, this new clinical module should provide a welcome addition to a process that seems chaotic to outsiders.
Coming prefigured for managing the entire process, it should allow for more and better organized studies, better and easier to manage clinical trials and ultimately, in the long run, more drugs to treat more illnesses.