PHOTOGRAPHY: JIM SHIVE ILLUSTRATION : PAUL A. BELCI

To meet the challenges of the current climate in pharma, companies have initiated eClinical programs, which typically cover trial and data management, supplies, and biostatistics. A central issue in most eClinical programs is the implementation, use, and integration of EDC solutions. As its use is unavoidable in today's world, the agility and speed an organization shows in adapting to this technology is critical. Equally as critical in terms of a company realizing EDC's benefits: the planning involved, the necessary changes in both processes and organization, and the handling of the implementation of these changes.

Forging ahead

An eClinical program is a collection of projects with the purpose of delivering a series of benefits to a company in a coordinated manner, rather than in an uncoordinated one, as completed, separate projects. The benefits typically include:

• Shorter time from Last Patient Last Visit to Database Release (DBR)
• Better quality of data with the use of fewer resources (e.g., significantly improved review and query processes and reduced errors)
• Faster access to results
• Better monitoring of trial progress
• Improved relationships with monitors.

Operational issues

Technology. With technology, it's mostly a simple task of selecting between vendors by matching requirements for functionality, integration, and usability, and deciding on a strategy for hosting or having the system in-house. In dealing with the vendor, a few business-related arrangements are necessary in order to ensure successful EDC implementation, including:

• Agree upon the ramp-up speed from going live to full implementation, and follow up with the vendor about their manning strategy as the workload increases.
• Dedicate personnel to handle the practical issues with the vendor (in addition to selecting personnel to handle contractual issues).
• When selecting a vendor, make sure the terms for bringing in an application service provider solution are agreed upon at the project's start.

People and processes. When it comes to implementing EDC solutions, the biggest challenges in these two areas can easily be grouped together, since new processes affect people, and vice versa. These challenges include, but are not limited to:

• The transition from paper to EDC can be difficult; some sites may have reservations about EDC, given varied computer experience and high turnover among site personnel.
• Monitors have to adjust to a very different way of working (a faster turnover in queries and investigator questions, which must be handled by the monitor).
• A very large stakeholder group diverse in geography, professional area, and relationship to EDC makes the communication of the change very complex. The size and diversity of this group also make it difficult to target and meet the training needs of the different stakeholders. Besides this, the training must be scalable and it must be timely in regard to when the stakeholders first start using EDC.
• Change is hard, and new data management processes and functions must be introduced, especially related to the front-loading of tasks connected to data collection, cleaning, validation, and DBR.
• Since the new processes, roles, and responsibilities must be sustained from the time of full implementation of EDC, the organization is challenged not to revert to the same processes used with paper-based trials.

The way to deal with all these issues points back to one major eClinical program component: change management, which can mean the difference between whether an EDC implementation is successful or not.^3,4