This really depends on the size and complexity of your study. Key drivers of the overall costs are the number of sites, patients, assessments and time.
- One site in Germany or 10 sites worldwide to be initiated, managed, monitored?
- 20 patients or 200? All easy to enroll or a very specific, hard to find population?
- One follow-up visit for each patient with a QoL questionnaire, or 10 monthly follow-ups including a CT-scan for each patient, each visit?
- Running a study for 3 months or 3 years?
Formulating an endpoint can be complex. Key aspect is to make sure the endpoint is measurable and clearly formulated. A good clinical evaluation is the starting point. After searching the literature, summarizing all data, putting together all tests and validation; which question is still unanswered? Can you formulate an endpoint that will answer that question?
In any situation, pre- or post-marked the sample size needs to be calculated by a statistician. It needs to be justifiable why the number of patients is sufficient. The sample size depends on the certainty in performance and/or safety you are looking for, and the standard deviation of the population. At Qserve CRO we have statisticians available to support your statistical justification.
Monitoring is an important tool to assure quality compliance. The need for monitoring can be best determined case by case. Risk based. Within monitoring there are a lot of options differentiating from classic on-site source data verification (SDV) till remote monitoring with a risk-based frequency.
Maybe you have a network of physicians or some key opinion leaders (KOL) that are willing to participate in your study. If not, or not sufficient we can qualify sites for you that fit your clinical activity. Maybe you are looking for a specific population, or you are still looking for that one, big, academic hospital to complete a differs group of sites. We have experience in how to approach and motivate sites and can rely on our network to bring your project up to speed
Which type of clinical activity is suitable depends on the need. Again, we have to start with the clinical evaluation. What question needs to be answered? How big is the clinical data gap? Looking at all options; post-market study, registry, retrospective data collection, surveys, which method seems most suitable? Qserve CRO can help you consider, weighing the pros and cons.
At Qserve CRO our monitors and CPMs work with multiple EDC providers on a daily basis. Selected by the study sponsor or based on our experience and suggestions. Therefore, we know the systems from the inside out. We work with preferred partners and can help you select the vendor that suits you best.
Yes, this is frequent request. Our review includes all aspects from clear endpoints, unambiguous language, till GCP (ISO14155) compliance.
Maybe there are other solutions. If you have a class III, pre-CE device we have to disappoint you. A clinical study is a regulatory requirement. But for lower risk devices and in post-market clinical follow-up (PMCF) together we can explore other, more economical options.
Qserve CRO provides interim solutions, trainings, on-site or remote support. Please contact us and we can discuss your needs.
The benefit of having a partner with a broader scope is that they can provide support in all relevant areas, if necessary.
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 theregulations is much better.
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.
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.
Contact us for further support from our dedicated CRO team including experienced CRAs, CPMs, statisticians and clinical consultants.Contact us