By Ann Neuer
April 27, 2009 | Image Solutions (ISI) is bringing greater efficiency to the collaborative document management space with the integration of its Regulatory Solutions Suite with Microsoft Office SharePoint Server 2007. SharePoint Server is Microsoft’s tool for facilitating collaboration and supplying access to data that are essential across the organization.
Toban Zolman, ISI’s director of consulting services, says the integration offers extended functionality and streamlined processes to the growing number of clients who use SharePoint Server. “We’re seeing a trend whereby more life science companies are embracing SharePoint as the go-to platform either for collaboration or as a system to manage documents. This brings our regulatory suite to more of those companies,” he notes.
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| Toban Zolman |
Improving operations within collaborative space is a visible concern for biopharmaceutical sponsors who are outsourcing multiple functions such as R&D; chemistry, manufacturing and control (CMC); clinical trial operations; and regulatory submissions, all in an effort to accelerate timelines and contain costs. To support this effort, they need a resource that speeds the flow of information internally and among external providers who are increasingly involved in all aspects of pre-clinical and clinical development. Zolman explains that collaborative efforts with outsourced partners for regulatory purposes have never been greater as regulatory authors and publishers build submissions with input from multiple areas within and outside the organization. “There is another level of abstraction and complication when sponsors are not performing these functions on their own. They may be partnering with other pharma companies, outsourced providers, and leveraging resources from contract research organizations (CROs). So, it isn’t just cross-functional, but cross-organizational,” Zolman says.
The new integration creates a single collaborative space and additional functionality for partners using eCTDXPress and ISIPublisher, ISI’s flagship regulatory products. For starters, clients will be able to leverage metadata that may already exist in SharePoint columns by pulling it in to populate content in the electronic common technical document (eCTD). Specifically, the metadata will help build study tagging files (STFs) and populate leaf titles, basic components of the eCTD. These new functions significantly reduce the amount of manual work that is typically done to complete these tasks. Before the integration, the publisher had to pull content from a fileshare or from other systems.
There are two options to access the integrated product—a hosted option and a custom installation. According to Zolman, the hosted solution is the more cost-effective choice. “With the hosted set-up, we have a pre-qualified system, meaning that all of the validation steps have been completed. We create a single virtual environment, execute the installation qualification and operational qualification just once, and then copies of that environment can be deployed again and again to multiple clients without running those scripts each time. This radically reduces the overall validation time and cost associated with each implementation,” Zolman says.
Traditionally, the hosted option has been the choice of smaller companies, with their more limited resources, but that paradigm is changing. Larger customers are now starting to look to hosting and Software as a Service (SaaS) as viable choices instead of their typical penchant for custom installations. Driving the market to the hosted option are the difficulty and cost of maintaining the change control on customized software.
ISI expects the integration of its regulatory suite with SharePoint to be a hit. Based on first quarter, the company is anticipating a 50 percent increase in SaaS revenues in 2009 as compared to 2008. Looking ahead to 2010, ISI projects a 20 percent growth in SharePoint-related revenues, quarter over quarter.