One of the big challenges in a small biotech company – when starting a clinical research unit from scratch with your first clinical trials – is finding the right balance with your quality assurance system. You have no system established internally when you start up your activities, you probably more or less need to outsource the majority of your activities – and you work under great time pressure.
Nevertheless, you need to get it right from the beginning – and the consequences of your decisions around how you handle your quality assurance during the start-up phase do not come clear before many years later:
- You need to find the right balance when defining which activities to keep in-house – and which activities to outsource.
- You need to define the level of detail your quality assurance system will need in order to be unambiguous in your definition of responsibilities, accountabilities and documentation needs
- You need to recognize your oversight responsibilities and establish an oversight strategy which is aligned and integrated in your quality assurance system
Last, but not least, you need to tailor your quality assurance system to the project (s), the particular outsourcing strategy and oversight approach.
There is a huge difference between a standard phase I, a small phase II in a well-known indication and a large phase II in a new indication.
Many small and virtual biotech companies choose to outsource the majority of the clinical project activities – especially in the beginning of the companies life-cycle – and specify in the contract with the CRO which SOP’s are applicable for the specific project.
The potential for the big mistake is to fail to recognize, that this approach does not guarantee success.
However, it is not uncommon, that the amount of internal resources needed to keep oversight of the outsourced activities are underestimated.
Of course, a clinical project can run smoothly, if it is small with a simple protocol running at a few sites. However, the execution risk increases considerably the fewer resources are spent on oversight activities.
Neurosearch, a danish biotech company, published a press release yesterday regarding a recent negative finding from a GCP inspection performed by the Danish Health and Medicines Authority. The decision to publish a press release on this finding is interesting, since it appears to be quite uncommon to go into the public with this kind of information.
First of all, the inspected trial is more than 5 years old – and the inspection was not carried out before last year.
Secondly, the fact that the company chooses to publish the information as a press release gives the impression that the nature of the breach is serious – and may even impact the value of the project.
One can speculate, whether this trend is in line with the recent increased regulatory focus on quality assurance and oversight responsibilities of sponsors. Most likely, Neurosearch outsourced a major part of the responsibilities at the time – and possibly – did not recognize to sufficiently resource the oversight of the activities.
Now, 6 years after the trial, it will be impossible to hold the CRO responsible for the failure – and it is clear from the authorities point of view (in line with the GCP regulations), that the company is responsible and not the CRO.
So today, Neurosearch faces a potential serious blow on the project value through questioning by the authorities on the validity of the collected safety information. Apparently, the breach – and impact on project value – is serious and real, since they choose to inform the stock market.
The learning for everybody else in the business must be:
Do not underestimate your oversight responsibilities, the allocation of responsibility and accountability – and understand the potential impact on project value, if you fail to get it right.