Get the Business Right First

Choosing eClinical solutions can appear, at first blush, to be a tricky proposition. Mirroring the life sciences industry itself, the eClinical environment is undergoing rapid change. Software manufacturers—ranging from Fortune 500 companies to small startups—are developing a host of better mousetraps to help overcome the considerable challenges facing life sciences companies. Mergers and acquisitions are rampant, as companies snap up providers of innovative new solutions or technology, or acquire an established company in order to expand their product offering.

Mike Lange

All too often, however, companies simply start with an existing category and work from there (e.g., "we need a clinical trial management system, now we just need to find the best—or cheapest—one").

This is upside down. The very first question on your list must be: What are the primary business objectives for adopting a new solution? Examples include (but are not limited to) compressing clinical trial timelines, reducing trial risk, accurately predicting and managing trial costs, and streamlining the outsourcing process. List your business objectives and prioritize them, with input from users as well as all stakeholders: clinical operations, outsourcing, finance, project management, IT, and so forth.

The second question to ask should be: Do we have specific business requirements for a new solution? In other words, what should the new solution be able to do to support the agreed-upon business objectives?

An effective approach is to start with what the current system does well—as well as its limitations—in supporting your business objectives. Ask existing users and stakeholders what they like, and don't like, about the current solution. Identify what existing business processes will be affected by a new solution and the impact on different stakeholders. Probe for strengths and weaknesses, focusing on measurable criteria, such as accuracy (e.g., of data generated, of forecasts); time and effort (e.g., to use the solution, to generate meaningful information); and visibility (e.g., to trial data and parameters, to different trial scenarios).

Don't stop there, however. Think big. Make the business requirements your wish list, as long as the wish list is aligned with the business objectives you have already identified. Focus on significant gains rather than incremental improvement. Many life sciences companies are pleasantly surprised at the rapid pace of innovation taking place in the eClinical arena, and the ability of these innovative solutions to enable tremendous gains in productivity and efficiency.

A word of caution. Be sure to make upper management an integral part of this initial phase, with input into, and signoff on, the business objectives and requirements. Although this may add time and effort up front, your search will be faster and more effective in the long run—and will help ensure that any new solution is aligned with the organization's broader corporate strategy.

As you can see, putting the business first also reduces the importance of debates such as the merits of eClinical suites vs. "best-of-breed" solutions. Your optimum solution will fall into one camp or the other, but it will be for the right reason: Your new eClinical solution adds significant and measurable business value to your organization.

An expanded discussion of this topic—"10 Questions to Ask When Evaluating eClinical Solutions"—can be found online at appliedclinicaltrialsonline.com.

Mike Lange Senior Director Marketing Communications ClearTrial E-mail: mlange@cleartrial.com