Going Electronic: Paving the Way for EDM

"We don't want the paper. It's just that plain and simple."

Keith Williams (left), Dr. Neil Rotherham (center), and Patrick Hughes of Good Products smile for a photo in front of their booth in the Exhibit Hall.

So said Michael Fauntleroy, program manager of FDA's Electronic Submissions Gateway, at the Drug Information Association's (DIA) Electronic Document Management (EDM) Conference held February 5–8 in Philadelphia, PA. Though he was speaking specifically about FDA, no sentence could better assess the current state of EDM in general.

It may seem like a burden to uproot paper-based ways in favor of electronic document and data management, but the consensus is that EDM ultimately makes work easier, more efficient, and more accurate for all concerned. At the conference, presenters examined changes that are both presently underway as well as on the horizon and discussed suggestions for adopting a new EDM solution.

Metadata

The proper use of metadata is absolutely crucial to the success of EDM, as it affects Document Lifecycle Management, rules-based document generation and assembly, submission assembly and publishing, and integrated submission management, noted Gabor Farii, life sciences solution specialist for Microsoft. The key to creating usable metadata is simple: Organizations must focus on making it consistent, as disciplined, well-structured metadata enables a more efficient workflow by helping eliminate extra work due to mistakes.

"This is really where the problem lies. Metadata is inconsistent," said Ed Chase, solutions architect–life sciences, health care, manufacturing for Adobe. "You have different file formats and each is going to have a different metadata structure. The second challenge is the application inconsistencies. This is when you start talking about the tags, file tags, and that stuff."

As a proposed solution to this problem, Chase cited Adobe's XMP: The Extensible Metadata Platform, which is a framework for storing information and allows users to synchronize centralized and document-centric metadata, as well as preserve domain-specific metadata across file types.

Microsoft is currently working on a different system that will aid in simplifying metadata—namely, an Office program in which content management goes hand in hand with the document so you never need to leave the Office interface. This type of federated system is favorable, since it "talks" to all other systems that are both metadata aware and unaware.

Regulatory

Standardization and consistency were also prominent in sessions delivered by regulatory personnel. Lise Stevens-Hawkins, CBER data standards project manager, asserted that the FDA is committed to using open, consensus-based data exchange standards whenever possible in order to support functional interoperability, data reuse, and cross-referencing. Due to the current state of submissions, she said, the FDA is receiving the same information over and over again with no way to use it practically because of all the different terminology. To address this problem, there are a few standards under development, including CDISC to HL7 Content Message, which promotes data exchange using the HL7 standard; the creation of one message model for standard study clinical data; and integration with SPL, ICSR, and RPS standards to enable data reuse and cross-referencing.

The changing regulatory landscape focuses particularly on the electronic Common Technical Document (eCTD). As of January 1, 2008, the eCTD became the only recognized electronic submissions format without a waiver in the United States. While paper submissions are still accepted, the FDA discourages them.

The FDA is also continuing to try and make eSubmissions as simple as possible with the creation of the Electronic Submissions Gateway (ESG), an agency-wide solution and central transmission point for accepting secure electronic regulatory submissions over the Internet, automatically routing submissions to the proper FDA center or office.

The EU shares the FDA's preference for the eCTD, as can be seen by examining the guidance on the horizon: Current guidance remains in place through July 2008, at which point the EMEA will accept electronic-only submissions in either eCTD or non-eCTD format, though eCTD is preferred. By January 2009, the EMEA will strongly recommend submitting electronically in either eCTD or non-eCTD format, and will strongly recommend eCTD only as of July 2009.

Document management systems

Since the regulatory environment is becoming more insistent about the use of the eSubmissions, companies are going to have to rethink their document management strategies.

Patrick Hughes, senior vice president of strategic business development for Good Products, agrees. "Both the FDA and the European regulatory bodies are moving to eSubmissions, and what that seems to be having an effect on further up the food chain is that companies are saying, 'Well, we know that we're going to have to embrace eSubmissions, but we need to get our house in order first and actually get a compliant document management system so that we're prepared for either [wanting] to do eSubmissions because it's more efficient anyway, or [being mandated] to do it, which might be just around the corner.'"

Hughes and the Good Products team recognize both the need for EDM solutions as well as the reluctance to adopt new technologies, so they have come up with a platform that simultaneously addresses both of these issues. The company's EDM product, called g-docs, is based on Microsoft SharePoint 2007 and utilizes g-train, a learning technology, and CoSign, a digital signature solution, with the added bonus of consultancy to ease users through the transition and help them evaluate and restructure workflow processes.

"We could go to somebody and say, 'We could do anything for you, just tell us what you want,'" explained Hughes to Applied Clinical Trials. "Well, they often don't really know what they want, which I think is why the consultancy angle that we have is quite interesting."

Indeed, it is imperative for companies to analyze their current processes before upgrading to EDM. According to James Reilly, a consultant for Octagon Research Solutions, analysis can provide quick answers for planning, execution, and delivery; practical information to make decisions and persuade management; historical information, used as a comparative tool; and data to plan submission schedules and balance workloads.

Once analysis is complete, companies must decide upon and deploy the new EDM solution. Communication is key throughout deployment so no one becomes frustrated or overwhelmed.

Brian Hamilton, associate director, quality systems and training for Abbott Laboratories, cited ways to make the transition as smooth as possible. First, staff members must understand the work they will be responsible for and receive appropriate instructor-led and Web training as well as access to online help and user guides.

The company must then prepare clients for the switch. During the shutdown of the old system, be sure to set reasonable expectations in terms of performance, features, processes, etc., and communicate the availability of training, the support model, and the work that clients need to do to prepare for migration. Once the system is down, make sure clients are aware of the temporary processes enacted to keep the business moving along. Finally, when the new system is launched, be sure clients have access to extra support.

In a nutshell

Whatever your company's current document management methods are, one thing is clear: EDM is not just the future of document management. The transition is happening right now and will continue to pervade the industry. As Hughes noted, "Somebody was saying that [at this conference] four years ago, there was probably a quarter of the number of delegates, if not less, and about 12 vendors, and now, every other booth in the hall seems to be doing something in eSubmission or eCTD." And if you're not ready to jump on the EDMbandwagon, too, you're going to be left in the dust.

Samantha Etkin is the associate editor for Applied Clinical Trials, email: setkin@advanstar.com