After being responsible for making hundreds of proposals and being involved in running a huge number of clinical trials, it always struck me how diverse different biotech companies are performing their selection process to find the right CRO for their project.
Ultimately, achieving best value for money is considered a very important criterium, but this is not always easy to determine. Especially not, if you are a small (almost virtual) company with limited experience in running clinical studies.
Below, I have listed six hands-on points which are in my view important to consider and these can contribute to selecting the right CRO for your project.
1) Have realistic expectations on timelines & scope of the project
Often CROs are asked to do a certain project using very short timelines and within a certain scope. Whilst challenging timelines & scope can be perfectly fine of this is fully discussed and disclosed from both sides, unrealistic timelines & scope will per definition be the recipe for failure. This will cause increased costs (for both sides), frustrations, delays and quality issues. Ultimately, I believe that clients are always better off when they realistically, together with the CRO, determine timelines and scope of the project and this will certainly contribute to keep the no. of change orders as low as possible.
2) Always ask for clarifications in case you are missing certain items in the proposals
If certain items are not listed, it is likely that the CRO is either i) assuming these items are not needed or requested by the client or ii) that these items may be included in other line items. Besides new insights and/or requirements during the course of the clinical trial, a strong review upfront to truly understand the proposal received from the CRO is one of the main reasons to reduce the no. of change orders.
3) Don’t put too much value in providing a mandatory bid grid for CROs to bid
Whilst in theory the comparison of different bids using one uniform bid grid should be much easier, in practice this often is only partially the case. Not a single CRO is using exactly the same separation of tasks, line items and this means that CROs will all have a different separation of cost categories and which sub-items are included in these cost categories.
Furthermore, by forcing CROs to pool their own ‘unique’ line items, you may lose valuable information on their cost structure, way of working and accents they have put in their work processes.
When you do choose to use a mandatory uniform bid grid, ask the CROs to also provide their own standard bid grid as an attachment so you can dig a bit deeper, if necessary. Also provide a spot on your uniform bid grid for the CRO to put their unique costs that can’t logically be put under one of the uniform cost categories.
4) Find out what the weak points are for the CRO and how they are mitigated
All CROs will be showcasing their strong points in their proposals. This is very logical and there is nothing wrong with this. Obviously, nobody can be good at everything so every CRO will also have its weak points. Again, there is also nothing wrong with that, as long as the CRO has good knowledge of it and has taken sufficient mitigative actions in order to prevent this becoming a problem during the course of the study. Building a good relationship in the selection process with the CROs and asking the right questions will help you to determine this more accurately and thus making the right decisions upfront.
5) Don’t select the CRO too early before starting the project
During the selection process, all clients would like to meet with the actual CRO team that will be performing the study on a day-by-day basis. This is a completely logical request, as effective communication within teams and between teams is crucial for the success of your clinical trial. However, if you make the selection for the CRO too early, it will be impossible for a CRO to provide with certainty a team, as obviously months down the line other projects may have started and/or employees may have left. Therefore, make sure you select your CRO on-time, but not too early to get surprises when the project starts.
6) Don’t micro manage the selected CRO
It is now common knowledge that employees generally will take more responsibility, perform better and be happier at work when you coach them and provide them with the necessary support for them to do their job. A parallel with this could be drawn towards the Client-CRO relationship. The best Client-CRO relationships are built on the basis of trust. Micro management will definitely not result in achieving the most commitment of the CRO to make the project a success. If you feel micro management is really needed as the project is in danger, you need to consider whether you made the right choice of CRO or if there are other (internal or external) reasons for causing this.
A short disclaimer: the intention of this blog is not to be covering all concepts, but to initiate / continue a discussion with the ultimate goal to serve the true patient needs.