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By Ann Neuer

Feb. 7, 2008 | Providers of clinical trial technology are now being chosen based on how they can serve a greater strategic purpose, says Ashok Bhat, VP international services at Phase Forward. "Sponsors are moving from tactical to strategic decision-making in vendor selection as they seek to automate the entire clinical trials process across multiple therapeutic areas. This is part of an effort to expand capacity while cutting costs for all of their clinical trials instead of looking to automate just one trial at a time, and they need strategic partners who can help with this transition," Bhat says.

If sponsors expect to achieve the desired improvements in clinical trial performance, they should take a strategic instead of tactical approach to how they select vendors. For starters, forward thinking sponsors need to do more than rely on checklists that mostly ask vendors about their technology.

"The most common mistake in selecting a vendor is looking only at the technology instead of focusing on how the technology can bring the strategic benefits the company is seeking," says Bhat. "How the screens look is important, as are functions and features, but it's not the most critical thing." What's really important, Bhat explains, is to ask questions such as: does the vendor have a track record in scaling global studies, can the vendor run 100 clinical trials in six months, can the vendor host trials, has the vendor been able to reduce cycle time while improving quality?

Questions such as these are being asked at the highest level, which means that vendor selection is moving out of siloed operations and into the ranks of senior level executives. Input from the clinical data manager (CDM), for example, is required to strategize about managing the project plans for the data and determining the degree of data management outsourcing being planned. According to Bhat, "The CDM and other high-level executives have become very focused on these sorts of high value-added activities." 

Kristan Gallitano, VP data management solutions for Eliassen Group eClinical Solutions Division, agrees that input from the CDM is key to selecting the right technology provider "There are huge discussions around integration of technology that companies already have. Sponsors may also be discussing the pros and cons of a central data repository as part of a bigger strategy. This is why the CDM must be included or brought in if the sponsors, particularly smaller ones, do not have this function in-house," Gallitano explains.

She says that many functions must be represented around the conference table. "The biggest mistake we see is failure to include representation from functions that will be affected by the decision. Sometimes, the importance of some perspectives are overlooked and not discovered until the company goes to implementation. If you don't have their input from the beginning, you won't have their buy-in when you start implementation."

A final blunder is overlooking the end-user -- the investigative site. Bhat of Phase Forward says that ultimate success or failure of a technology implementation rests with the end-user. "We see end-user acceptance as one of the absolute critical success factors.  Has the decision-making team asked how the end-user will be supported by the vendor? Is this question even on the checklist? One of the most critical mistakes is a failure by the team to go out to sites and ask about their experiences with various technologies. The importance of getting those references and checking them cannot be overstated," Bhat says.


 





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