Clinilabs Teams with Microsoft

As small-to-midsize pharma and biotechs become less active thanks to the economy, their usual partners, smaller CROs, face dwindling demand for their services. Outsourcing among big pharma continues, but data show that the bigger CROs are their preferred choice. So, what’s David to do when not only surrounded by Goliaths but also other Davids? Try to stand out, naturally.

In the case of Clinilabs, an early phase CRO that offers specialty clinical services in therapeutics, centralized processing, and technology products, standing out meant developing cost-saving software. Specifically, source-document management software that the company’s President and Chief Executive Officer Dr. Gary Zammit says “can promote a real change in how monitoring is done.”

But before we get to the how’s, let’s start with the why’s.

Having conducted 170 clinical trials since 2001, Clinilabs was no stranger to the high price of document management stemming from the cost of sending monitors to sites to check electronic case report forms (eCRFs) against paper records. [Despite the technology, a number of investigators still use paper.] And as trials became more global, the price increased. These costs could be cut, Zammit ascertained, by digitizing and centralizing the process.

To bring this vision to life, Clinilabs teamed up with Microsoft, using their Office SharePoint Server 2007 to create Clinical InSite. The decision of a partner, according to Zammit, was based on cost and familiarity. With SharePoint, the software could be produced and deployed inexpensively, and would require little training since most people are familiar with Microsoft functionality.

“The last thing you want to have to do is train some investigator site in order to report their clinical data,” says Mike Naimoli, National Director, U.S. Life Sciences Group, Microsoft. “You want to make it easy for them.”

For Clinilabs, that meant taking into consideration the fact that many investigators still fill out source documents on paper. “One of the reasons we wanted to use this type of system was that paper documents just get scanned,” said Zammit. “So the doctor works in the same way and the scanning can be delegated.” 

This function, which also allows for faxing, is critical. Because with eCRFs and source documents uploaded directly into patient folders on Clinical InSite, a monitor can verify the data from their own computer. Without leaving home, they’re able to pull up both forms on the same screen and perform a side-by-side comparison. The beauty of this Web-based, centralized system is that it can decrease the number of monitor visits by half, says Zammit. That translates into a savings of $465,000 per study, or a 35% reduction in monitoring costs, according to a Microsoft case study.

Savings are also realized, Zammit points out, through better employee retention. Less travel helps prevent a common ailment among monitors: burn out. And when monitors stay onboard, companies don’t have to spend money on recruiting.

In addition to cost savings, there are also organizational benefits. Everything—protocols, protocol amendments, regulatory documents, lab results—are all in one place. “The whole clinical development team now has a single place to go for electronic document management and it’s validated,” said Zammit. 

Bells and whistles
SharePoint can be used out of the box, but Clinilabs chose to customize it. “There are already a lot of programs that are used in clinical trials,” says Karina Palafox, Clinical Data Manager for Clinilabs, “so we wanted to simplify that as much as possible with the software and implement a few functionalities that we thought would be useful in project management.” 

One such functionality is a reporting function that allows project managers and monitors to track work flow and perform more specific document searches. The other addition is a comment function that lets users add comments and queries directly to documents within Clinical InSite. This means that questions can be asked and answers provided without having to email back-and-forth.

Simplification is also achieved through the interface, a basic tree structure, which has received only positive feedback, says Palafox. The set-up is customizable, and Clinilabs involvement in maintaining the site depends on what the sponsor wants. “Our involvement can be as much or as little as [they] would like,” she says. “It’s sort of an appeal to sponsors that they don’t have to maintain the site as well.”

(Image by Danilo Rizzuti, courtesy of FreeDigitalPhotos.net)