Big Pharma Leads Way on EDC Projects

Large drug manufacturers continue to be the big drivers behind the broadest electronic document control (EDC) initiatives, as evidenced by several presentations at the recent DIA conference in Philadelphia.

EDC continues to face something of an uphill struggle when it comes to acceptance among smaller and even some midsized drug and device companies, experts have told PIR. But any success with the technology enjoyed by the industry's biggest players will push others to speed EDC adoption, vendors hope.

Merck's Worldwide Regulatory Operations' Amanda Keller said her company faced a challenge and opportunity as it approached EDC. While nearly 70 percent of submission components are not submission ready, Merck believes two-thirds of its quality issues "could be avoided if contributors complied with provided standards and guidelines, adhered to agreed timelines and provided quality documents not needing rework," she said.

Challenges and Benefits

Keys to a successful EDC program include defining problems at the root cause, gathering the data to measure the problem, listening to feedback from internal and external customers and ultimately understanding "your process before you try to fix it."

Also important is submission management -- the planning, tracking and management of submissions and their individual components.

At Merck achieving a good EDC program was complicated by several process challenges, including:

No centralized approach for managing the status of and tracking information for submissions; Redundancy in tracking charts create confusion, extra work and lack of consistency; and The number of global, simultaneous releases was increasing.

Keller said she devoted a great deal of energy to effectively managing the EDC team. That means having an accurate and up-to-date plan that includes what is going in the submission, what granularity is needed, who is responsible for which components, and how accurate and realistic the timeline is.

Companies should ensure that everyone is working off the same plan, she stressed. "There is no such thing as too much communication."

She also advised using repeatable and predictable internal processes because they are easier to automate and support with technology, and outsourcing opportunities will be more manageable.

Ultimately the benefits of an effective EDC program are clear for a global company, said AstraZeneca clinical document leaders in the UK and Sweden, Suketu Patel and Susan Schultz-Rachman. Those benefits include:

Global resourcing: This allows you to share the workload around the clock, provides increased flexibility, and invigorates the coaching and mentoring programs. A global system: This provides immediate access to all documents for submission preparation, cuts down on travel and engages project team members from different countries. Harmonized processes: These provide greater transparency and ensure compliance with authority regulations in various countries.

At AstraZeneca, interest in EDC was driven in part by a desire to improve product time to market and get things right the first time, said Patel and Schultz-Rachman. But those goals could not be achieved without giving proper attention to basic administration challenges, they said.

Those admin challenges include identifying someone to handle:

Correctly placing the named template in the document management system; Permission granting; New account requests; Word support; Reviewing tools; Functional publishing; and Approvals and signature page support.

Training users is also important, they said. And that doesn't necessarily mean longer training sessions. Instead, focus on half-day sessions but make certain the gap between deployment and training doesn't drag on too long. Delays between the training date and using the application can harm training effectiveness, they said.

But an entire day of training does not benefit most users, they added. Instead they advised scheduling a half-day training session for new users and a separate half-day session that is more role-specific. By taking a "less is more" approach you allow users to focus more on information they can use immediately, they said. -- Michael Causey

Consider Support Models

Support models for customers are critical components in any EDC implementation, said AstraZeneca principal document specialists Suketu Patel and Susan Schultz-Rachman. They outlined the pros and cons of two different approaches: calling the help desk or emailing.

Calling: On the plus side, it is easier to centralize support resources in a pool, but overall it can give the document management system (DMS) a black eye because users blame the support set-up for their DMS problems.

Current Group Mailbox Approach: Most requests can be handled on first contact, and at Astra the DMS user perception improved 33 percent in the first year after taking this support route.