Using Smaller, Specialized Companies for Clinical Trials

IRT Essentials

One of the recurring themes at a recent Chicago conference of pharmaceutical professionals was the industry's shift from a longstanding outsourcing model of searching for a 'one stop shop'  to a new model which favors employing a horizontal spread of uni-task experts to specifically target the diverse needs of a clinical trial.

"The success and wisdom of the new approach speaks for itself," says David Goldston, Managing Director of Veracity Logic, an IRT (IWR/IVR) provider. "We obviously agree with Sponsors who say 'Let's look for solid expertise, and let's nudge our project management strategy to encompass multiple inputs'. This approach stands to provide a greater return in the areas that matter most: quality, efficiency, reliability...and, often, economics."

"For example, Veracity Logic focuses entirely on deploying global IRT systems for Sponsors and CROs. It's what we do, so naturally you would expect us to do it better than a 'generalist' would," Goldston points out. "And, of course, we like to think we do!"

Since focused expertise providers include many small companies as well as some large ones, the new model requires reconsideration of the pros and cons of using smaller companies. Conference speakers listed as one of the “pros: of using a smaller company the fact that smaller companies tend to sell with their A Team and deliver with their A Team, as promised...not always the case with large vendors who, Sponsors note, may start off with the A Team and later deliver with a C or even D Team.

"And there are other very good reasons to consider using smaller companies," Goldston says. He lists the following benefits:

  • The possibility of getting a better economic package, given the lower overhead.
  • Personal touches, including direct contact with senior management for project issues.
  • Less staff turnover.
  • Typically have the same Project Manager throughout the study.
  • Greater flexibility. Small companies are more able to move/adapt quickly.
  • Streamlined approval process for deliverables.
  • No up-selling.

The most predominant ‘con’ of using small companies is concern over a perceived lack of ‘bench depth’. This concern is often spurious. Typically, a two-year clinical trial experiences either one Project Manager throughout the study, or a maximum of two in cases of unexpected attrition. And with smaller companies, the second Project Manager has already been the understudy to the PM all along. This means comparatively low transition pain should the worst occur.

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