By Ray Tobey, Chief Medical Officer on Mar 20, 2017 8:50:47 AM
Let's say you represent a rather small pharmaceutical research company and you need help in clinical development for your drug candidate. How do you find a suitable CRO for your particular needs? What characteristics should you look for among the multiple choices you have in selecting a CRO? Should you go for a large CRO or a small CRO?
Here are some things to consider.
The most important characteristic you need is QUALITY, QUALITY, QUALITY. Without it, you will have a real problem.
How to Assess Quality in a CRO.
The first thing to assess is the experience of the team that will be actively managing your project. Commonly, the marketing and sales representatives for a large CRO will be very experienced with many previous projects under their belt. The individuals you meet will be competent and excellent. But are they the people who will actually carry out the project? Most of the time, no, because the senior people you dealt with at contract signing are off to other projects sales.
What to Be Wary of With a Large CRO
Once the contract is signed, there is a start up period where the experienced people start the organization of the project and introduce you to the next junior level staff. Things will start off pretty well. But as time goes on more and more responsibility is passed off to more junior staff. These are the people who actually carry out the project. Unfortunately, it can lead to quality errors and significant slipping of target times. There are many horror stories.
How This Plays Out with a Small CRO
Like the large CRO, the small CRO marketing and sales people are experienced and excellent. They will know how to do your project and are aware of the potential pitfalls in conducting clinical trials. However, in contrast to the large CRO where your contract is one of many, for a small CRO your business is critical business. The sales people will likely be the ones that will do the work rather than passing it off to junior and less experienced people. This makes a big difference in achieving your particular goals of timelines and budgetary targets.
What Else to Look For
Other characteristics to check out include experience in the particular area of your project. Every special field has pitfalls that only personal experience can make you aware of.
Check out references of other project work, focusing on quality, timelines and ease of communication. Was the work passed off to other junior individuals or was the supervision kept in experienced hands?
Budget costs are always a concern, especially for smaller pharmaceutical companies. The large CROs, just like larger companies, have necessary overhead costs that must be covered by contract revenue. The smaller CROs have considerable smaller overhead costs allowing their bids to be quite competitive. Obviously this is an advantage for both the smaller CRO as well as the smaller pharmaceutical company. And it should not be a negative for quality, quality, quality.
Timelines in achieving goals is another important aspect of any trial. During the pre-contract stage of activity, it is commonplace to over-estimate recruiting of patient volunteers by investigators. My own experience with this aspect makes me increase the estimated time of patient recruitment by 50-100%. This may be tempered by the actual patient types you need, of course, since some are easier than others. These estimates can be more reliable if the CRO has experience in the particular area of patient recruitment. Here again, responsiveness on the part of the CRO staff is dependent on the importance of your contract to the CRO and the past experience of the staff.
These are some of the highlights to consider when selecting a CRO for your studies. For the small CRO, your business is critical and will gain the full attention of the CRO staff. For the large CRO, if your project is on the small side, it is one of many for them.