Clinical Trial Management Systems

Here in Newcastle CTU we are currently reviewing our needs for and potential solutions in respect of capturing and managing data (and possibly also documents) for trial management, including management of our resources (budget, personnel etc) and for reporting (internally, to sponsor, for NIHR annual report etc) and planning purposes.  We are keen to be able to monitor and manage activity and ‘performance’ (e.g. recruitment to time and target, time taken to get approvals on a site by site basis) on a trial by trial basis, and also to set and monitor metrics etc for our portfolio of trials as a whole (e.g. the number in various stages from set-up to reporting at any given time).

 

We’re aware of some off-the-shelf software (e.g. MediData’s CTMS, which we’re having a demo of next month) and we’re also aware that some CTUs have developed their own systems, and we’re considering that option also.

 

To inform our thoughts and deliberations, we’d be very grateful if fellow CTUs would be willing to share how they are managing this type of data (as opposed to the clinical and patient reported data that are being captured and analysed in the trial)

 

Do you use software solutions for management/monitoring of (a)  individual trials and/or (b) your portfolio of trials as a whole?

If so, what functionality do these software solutions deliver?

What software are you using?

Is it a bespoke system or ‘off the shelf’?

Any other observations/comments on clinical trial management systems?

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