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Vendor Management/CRO Supervision > Project Management > Medical Writing > Clinical Trial Monitoring >  
Vendor Management/CRO Supervision

Having worked with and within CROs of various sizes, I know how CROs operate.  I can assist at any stage of the sponsor-CRO relationship.  Here are four suggestions:

  • For over two years I created CRO budgets and proposals, which helps when analysing and comparing budgets and has translated to savings when reviewing vendor budgets for my clients.
  • At study inception there are countless documents, plans and forms to be reviewed and approved by the sponsor; I have taken on this task for clients in the past, expediting the process and even helping to improve CRO templates in some cases.
  • The site qualification stage requires speedy decision-making by the sponsor so that ethics submissions and site contracts can proceed.  Being highly familiar with qualification visit reports I can quickly make the review and raise pertinent points for sponsor approval, along with my recommendation for site inclusion or exclusion.
  • Once recruitment begins the communication with and sponsor oversight of the CRO must continue.  I recommend sponsor review of draft monitoring reports so that red flags can be addressed before the report is signed-off and filed, but of course this takes time.  I actively enjoy this task and review monitoring reports 'wearing the hat' of an auditor.  

Although I am writing from the perspective of sponsor's representative and will have their best interests above all else, I trust that the advantages to the vendor/CRO are also apparent.