Originally published in 2014

We have all had that discussion with a CRO or a Sponsor. We want you to deliver a ”Quality” Clinical Trial. Usually the discussion goes something like this:

Sally (Sponsor): This is a really important trial for us, you know. My boss is putting so much pressure on me. We promised this to everyone and their uncle and we need to make this happen.

Charles (CRO): Of course, we fully understand. It is always like this. We will deliver a quality trial, we have lots of experience, great expertise and we understand your needs.

Sally: Great, because we really need a quality trial.

Charles: So, to make sure we are aligned, define quality for us.

Sally: You know, Charles! We want this trial to go well, we want good results and we want results we can use.

You can see where this is going. Now, the Sponsor has expectations and the CRO has expectations…and we hope they are the same and we “hope for the best”. This will definitely get us in trouble!

Like when a site has quality issues or there are issues with the investigational product delivery to site or the meeting minutes are not to our liking. Or when we have an inspection and something goes wrong…

Sally: But Charles, we told you we wanted quality!

Charles: Sally, It is quality data but you did not tell us you wanted to know about every little incident.

Rewind…What if we had implemented defined metrics for quality in our contract…

Would we be in this situation?

Tip:  To avoid these situations define some key criteria/metrics in the contract between the Sponsor and CRO:

1. Key metrics – What key parameters does the CRO measure and track and inform the Sponsor when they deviate?

2. Escalation mechanism – Who needs to know? When do they need to know? How do they need to be informed?

It is a cliché, isn’t it? If you do not define your expectations, you cannot expect the other party to see things the way you do.

Can you (and Sally) answer the following questions in real time in your trial?

Is primary efficacy data verifiable?

Were subjects actual real, alive and treated?

Did your trial answer the question asked?

Is there any evidence of underreporting of Adverse Events?

Do the analysis upfront. Identify which are the key metrics for you. Discuss them together as a team and decide at which point you need to track, at which point you need to monitor closely, at which point you need to take action and who is involved at each step. 

Now, when you discuss quality you will not have to “hope for the best” - you will know exactly what you are getting.

Skillpad helps clients in Pharmaceuticals, Biotechnology & other regulated industries to reduce costs, increase profitability and improve efficiencies. 


Nathalie Bourgouin, PMP – Vice-President Compliance, Skillpad Canada Inc. is a leader in project management and a subject matter expert with an extensive background in risk-based quality assurance processes and training in manufacturing and clinical trials areas.

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