QUALITY ASSURANCE
“Moving a live study sometimes requires more planning than setting up a study from scratch. If you don’t have a robust, deliverable migration plan, you probably haven’t thought about the number and type of resources that will be needed.”
issue – if the company is folding – that is an emergency as well. But sometimes there is a perceived urgency because “we can’t work with these people any more, we just want to be out”. What that means is your colleagues are more likely to take risky decisions that might impact the quality of the study and may even compromise patient safety or the integrity of the data.
How could companies prevent the need to move vendors?
The question I ask when we are working on a study is: did we (the sponsor and the vendor) actually start as one team? Do we truly consider ourselves as one team or do we consider ourselves as ‘Company A’ and ‘CRO B’? If you can eradicate that attitude and work as a team, then you will probably have a more open dialogue and have fewer issues. That goes into the no-blame conversations: did we adequately problem-solve as we went along? Or did we allow slippage to go too far before intervening? And did all team members have that open and honest dialogue?
What do we need to consider once we have decided to move to a new vendor? If we’re going to move, we need to have performed a root cause analysis to make sure we’re not going to repeat the same mistakes again. If you don’t know what went wrong and how to make it better, how can another CRO or supplier live up to expectations or know what you actually want? When moving, we also need to establish where we are in our study and what could be impacted by the move. What will the impacts be on other departments that are already working with, and relying on, this vendor as well? What about those departments who may be affected in the future by the change? Remember that you are going to need time
14 | Outsourcing in Clinical Trials Handbook
to set up the new vendor. Check that you have procedures in place to do migrations, transitions and handovers. Make sure you know how you’re going to be working between the two CROs. What if they’ve got their own policies on how to accept a study or how to release a study? What if there is a conflict between your policies and procedures and theirs? Have you looked at the number of resources needed, and available, not just your own resources but those in other departments? And, if you don’t have a procedure on moving to another vendor, how are you going to make sure that all activities are adequately documented?
From a QA perspective, what are some of the pitfalls and issues when moving vendors? Moving does require a lead time, and moving could extend the trial by months, and even in the process of moving, you could come across other pitfalls. Moving a live study sometimes requires more planning than what was needed to set up a study from scratch, and if you do inadequate or rushed handovers, you might end up with lots of reworking to do. In addition, if you don’t perform an adequate risk assessment, you might not know if you’ve managed to mitigate the risks of moving to that new vendor. Think about who is going to take responsibility for the move. Will it fall on the project manager who still must do their day job of running the study alongside this? Don’t underestimate the time and resources your project management team will need to work between two vendors. If you don’t have a robust, demonstrable and deliverable migration plan, you probably haven’t thought about the number and type of resources that will be needed.
What would be your final thoughts on this issue? This is a quick overview on what we need to consider when moving vendors. I’m not saying you can’t do it, just that if you choose to do it, particularly on a live study, then it will take time, patience and lots of resources. You will need to be a brilliant planner – and potentially have lots of money! You may even be paying two vendors at the same time! So, from my perspective, it is better to work on building good relationships and work through issues before the need comes to move to another vendor. All views are the author’s own.
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