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Taming the Beast


Going paperless speeds study review and gives clients real time access to process.

By Allison Proffitt

November 16, 2010 | Copernicus Group made a fairly weighty donation to a local North Carolina school last month: four boxes of paperclips and binder clips all formerly used to wrangle the “paper-moving beast” that was Copernicus’ clinical trial review process. The independent institutional review board (IRB) doesn’t need them anymore. They’ve gone completely paperless.

To assure regulatory compliance, IRBs review research protocols and study-related information, as well as investigator qualifications and resources. An IRB has the authority to approve, require modifications to secure approval, or disapprove research. Of the 200 accredited IRBs in the country, independent bodies like Copernicus account for only about 10%.

Copernicus Group is nearly 15 years old, and by 2006, they’d generated an astonishing amount of paperwork. 96% of forms came in to Copernicus electronically, via fax or email. But those forms were then printed, paper clipped, passed around the office, and often scanned at the end of the process, says Jennifer Sodrel, director of IT at Copernicus. In addition to that, the IRB had 22 linear feet of its own paperwork to deal with each week.

In 2007, Copernicus chose to go paperless, but not just moving forward. After getting started, the group made the unprecedented decision to scan over five million pages of active and open cases so that their entire database could be accessed by their clients.

Making the switch to paperless was essential for efficiency, says Sodrel. “We were able to take all of those images and electronic documents, route those through our process, make them searchable for our Board, more efficient in transferring, and then apply electronic signatures to those and make our output of documents 21 CFR Part 11 compliant.”

Copernicus started their own protocol tracking system , a proprietary software that was developed by Copernicus at its inception. Working with Sitrof Technologies, a company specializing in unstructured document management with extensive experience FDA 21 CFR Part 11 compliance, Copernicus was able to link its system to a compliant electronic signatures system. Xerox DocuShare serves as the backbone of the system. Sitrof installed DocuShare and then wrapped it with a compliance module created to automate the workflow and decision process for electronic records while maintaining Part 11 compliance. An outside service came in to scan, tag, and index the active forms.

Portal Advantages

In mid-September, Copernicus launched Connexus, fully validated, FDA 21 CFR Part 11 compliant and capable of providing a full audit trail for users and manages every phase of IRB documentation. With appropriate security permissions, users can call up forms they’ve already submitted and watch the tracking system, giving users real time updates on the status of the review, which documents are missing, and which need changes.

“We’re always looking to improve in everything that we do, whether it be quality or speed or efficiency. The use of technology in the form of Connexus has enabled us to achieve all of those goals,” says Bruce Tomason, CEO of Copernicus.

For the review board, Connexus provides searchable archives and all of the necessary forms in one place. “It enables [the board], we think, to make better decisions than they’ve made in the past,” says Tomason.

For clients, Connexus manages the submission process and enables audits.

“In a regulatory world, it’s all about being accurate and on time,” says Barry Mangum, director of clinical pharmacology at the Duke Clinical Research Unit. “We need to make sure that we have the right version control. We need to make sure that we have the right regulatory documents in the right place and engaged at the right time so that we can get IRB approval.”

Mangum’s group is doing hundreds of studies a year, mostly first in man or proof of concept studies. “Especially in the early clinical pharmacology world,” he says, “time is of the essence.”

Having worked with Copernicus for more than two years, and using the Connexus portal for several months, Mangum has found the working relationship with Copernicus to be “tremendously open and transparent”, something he believes can be uncommon in the world of clinical research.

The transition to Connexus was very easy, he says. And after the first few trials with Connexus, Mangum and his team took a step back to assess the process.

The tracking options in Connexus revealed some challenges to efficiency. “We were sitting on some documents longer than we needed to sit on them at our own shop and it became self evident after we did the look-back who was holding up what and when,” he says. Easy communication with Copernicus allowed for streamlining the process. “Once we figured out who was holding up what, when and where, we could go back and correct that.” •


This article also appeared in the November-December 2010 issue of Bio-IT World Magazine. Subscriptions are free for qualifying individuals. Apply today.
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