By David Mitchell and
Oct. 18, 2012
By 2006, Copernicus Group IRB (CGIRB) - a leading independent institutional review board based in Research Triangle Park, N.C. - was generating what amounted to a 22-foot stack of paper each week. The company also had a 1.5 million-document, 5 million-page backfile.
The situation impacted productivity, efficiency and the environment. Clearly, CGIRB needed to go paperless.
But due to the rigors of the clinical trial industry, just any “paperless office” solution wouldn’t do. CGIRB needed to take advantage of the immense problem-solving abilities of its staff, as well as a team of trusted partners.
Today, the company is 95 percent paper-free - and immeasurably more agile and responsive.
A special solution for a special company
CGIRB is a leading independent institutional review board, or IRB - a group whose primary responsibility is to ensure that the rights and welfare of human research subjects are protected. The CGIRB Board reviews research protocols and study-related information, as well as investigator qualifications and resources, to ensure regulatory compliance.
Running the day-to-day business at an IRB is incredibly paper-intensive, and requires a great deal of internal and external collaboration. Correspondence from trial sponsors, site managers and physicians naturally piles up. And because of federal regulations for data validation, version control and security, CGIRB was not able to take full advantage of increased adoption of electronic document submission.
Title 21 CFR Part 11 is a part of the Code of Federal Regulations dealing with regulatory guidelines on electronic records. All data storage at IRBs must be in compliance with “Part 11,” as it’s called in the industry. Because CGIRB didn’t have a Part 11 certified process for electronic document handling, it needed to print out each and every piece of each and every submission - no matter how it arrived.
As the paper piled up, the path became clear. CGIRB needed a way to handle its document load electronically, while staying in compliance with the regulations.
Finding a proven partner
“As organizations work toward minimizing paper to increase business efficiencies and reduce their carbon footprints, many look for technology solutions to drive and track their efforts,” explains Melinda Stoker, director of global marketing communications, Xerox DocuShare. “By adopting an enterprise content management (ECM) platform, for example, employees are able to store, manage, and archive documents electronically in addition to streamlining business processes by automating them with workflows.”
Initially, CGIRB sought a way to handle incoming electronic documents, and nothing more. But early in the investigation process, the company realized it was possible to become a completely paperless company - and established a very aggressive goal of doing so.
The project was big - accepting future document submissions, scanning their five million-page backfile, integrating with internal and public-facing systems, and enhancing workflows and company culture. Just any partner wouldn’t do. After a lengthy search, CGIRB settled on a two-tier solution of working with a company specializing in the management of unstructured content in the Life Sciences industry, along with an ECM solution that was flexible and cost effective.
Making the move to paperless
Combining the two solutions allowed CGIRB to develop a three-phase plan to meet their unique and specific needs. To start, CGIRB would begin using the ECM solution immediately to handle non-regulated documents and correspondence. Phase two involved scanning and uploading the legacy pages to an e-file room for viewing purposes only - allowing staff to adjust to the paperless workflow without creating Part 11 compliance issues.
Finally, after a “break-in” period, CGIRB would make the final leap of adding a compliance module to the ECM tool to automate the workflow and decision process.
From the very start, CGIRB focused on employee adoption and buy-in by creating subcommittees, focus groups and best practices teams from lines of business and IT. In mid-2008, the ECM solution was installed for use with CGIRB’s non-regulated documents, such as vacation requests, business development information, training information, PowerPoint presentations, spreadsheets, status reports, RFIs and contracts. Employees quickly became familiar with the solution interface, easing them out of their comfort zone in a non-threatening, relaxed manner.
CGIRB then commissioned a local firm to work onsite, scanning, indexing and archiving five million pages of legacy documents. Proper check-in/check-out of these live paper documents was essential throughout the conversion process, because at any point in time, CGIRB had to be able to locate any specific document - even if it had already been pulled for scanning.
Initially, the scanned documents were available through an e-file room for “read only” purposes. This allowed users to become familiar with the system and working with electronic records. However, because the system was not yet Part 11 compliant for decision-making, the original paper was still routed to board members. Thus by the end of phase two, and before full launch, users already had nearly a year’s worth of hands-on experience with the system.
In addition to making a certified and trustworthy duplicate through scanning, Optical Character Recognition (OCR) was applied to each page, converting it to digital text and allowing full text search of all five million pages of documentation.
Finally, a compliance module was added to the ECM solution, creating a robust document management collaboration tool supporting CGIRB’s mission critical function. The system was live - and CGIRB was almost 100 percent paperless.
CGIRB’s paperless evolution is green, efficient, cost-effective, compliant and competitive. With more than 96 percent of documents received electronically, eliminating the need to print documents allowed for a green work environment and a 51 percent ROI.
In the past, thousands of approval documents and correspondence were shipped out to sites and clients each day. Now, with updated SOPs and the technology in place to exchange electronic documents, paper is conserved, shipping costs are reduced and approval documents can be accessed instantly.
Once drowning in paper, CGIRB has emerged as a more nimble, efficient, agile organization. For the North Carolina IRB, going paperless has meant green - in both senses of the word.
David Mitchell is assistant director of e-systems and product management for Copernicus Group IRB. He can be reached at [email protected]. With comments from Melinda Stoker, director of global marketing communications for Xerox DocuShare. She can be reached at [email protected].