CRO selection requires careful examination. In order to make a good decision, it is important that you review the CRO service portfolio and the clinical expertise of the CRO team to understand if they are indeed able to help you with the request you have. A 30 min free consult is always offered by us to answer the majority of your questions.
Questions like below, are all questions that I hear every day as a business development manager for our CRO at Qserve:
- What is sufficient and valid clinical data for the MDR?
- Is a PMCF survey enough, or do we really need a full clinical study?
- How long does it take to collect clinical data?
- Do we need to submit a submission for each country in Europe, or is that done through EUDAMED?
- How many IMVs are needed per site?
- Is our clinical strategy good enough for the MDR?
- What statistical justification do we have to think of?
Since the MDR came into effect on 26 May 2021, the regulations changed and became more stringent. This caused for more questions to remain unanswered. At Qserve, we get all these questions, and through experience and knowledge we are able to help our clients. We understand, when you have to figure out the new regulations all by yourself, you sometimes get stuck, and you just need a second pair of eyes to bring a new perspective.
I think, it very important that our (new) partner has a clear view on all the services we have to offer as CRO and that is the reason we always offer ’30 min free consulting’. With no strings attached, you get 30 minutes with one of our Senior Clinical Consultants to ask any questions you might have. For many questions this will be enough time to fully answer your question and for more complex questions it will often point you in the right direction.
I would like to share some relevant questions on where you should focus on during your first meeting with a CRO:
- What is the scope of the services? Is the service only CRO related, or do they also offer support in QA/RA/CA consultancy. What about their experience with Notified Bodies? The benefit of having a partner with a broader scope is that they can provide support in all relevant areas, if necessary.
- Is the CRO 100% Medical Device focused? Most CRO’s have a mixed focus and in most cases, this means that the focus will be on Pharma since the budgets in pharma are much higher than in Medical Devices. Also, if there is a 100% Medical Device focus, it means that the understanding and expertise of the regulatory is much better.
- Is the CRO offering a customized proposal based on the customer’s requirements or a general proposal? In my opinion a customized proposal is more detailed and will give you more value for money. You only pay the hours that are actually spend on the project.
- How flexible is the CRO team? Do they only offer full services like an entire study, registry or PMCF survey, or can they only offer a supporting role and mainly provide feedback and reviews? I think it’s important that CRO can provide both; full services, and/or guidance services, whatever fits your company. Preferably with one point of contact that share the knowledge of your product.
If you have any questions for me or one of my colleagues, please feel free to get it touch. If you fill in our contact form, I will plan a consult and we would be happy to answer all your questions.