Trial Software – a double-edged sword

Trial Software – a double-edged swordAs I demonstrated last week, software issues diminish the ability of sites to recruit and enroll patients into clinical trials.  When I’ve shown these findings to clients, the first reaction is disbelief.  “Software?  Really?”

Yes.  Software.  As an investigator recently told me, “XXX’s system is the bane of my existence.”  Does that sound trivial?  Let’s put this into perspective.

A study coordinator is responsible for about eight trials.  Assume each trial has five software programs associated with it.  That equates to 40 software programs the coordinator is supposed to operate.  Not a simple task!

Many software programs require new passwords every 30 – 90 days.  Imagine your frustration having 40 passwords to deal with in your day-to-day work which must be changed every month or two.  Imagine also having to keep track of separate passwords for the investigators and other staff.

Many of the programs generate queries to be handled by study coordinators. Some programs have terrific technical support teams – others, not so terrific.  I’ve heard many coordinators complain that those on the other end of the telephone don’t really understand the clinical environment and are inflexible when some flexibility is required.

All of this leads to significant frustration levels at sites.  Software and passwords might simplify study management for sponsors, but often at the cost of site satisfaction.

As you look for technical solutions, ensure that when they all come together at investigator sites, study coordinators have a knowledgeable point of contact to help resolve their IT issues.

To accelerate patient recruitment and enrollment for your studies, contact me.  We can help.

Ross H. Weaver, PharmD, MBA

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