Conduct of studies with IVDs ISO 20916
Your competent partner for clinical performance studies of in vitro diagnostics in accordance with ISO 20916:2019-05
Why Choose Us?
Trust
Trust is one of our most important values. That's why we place great importance on the security of your data and only exchange it with you via secure servers in Germany.
Customer Satisfaction
Your satisfaction is our highest goal in all projects. For us, a project is only successful if you are satisfied!
Reliability
Do you need to solve a critical problem at short notice? Together, we can do it – even with an overnight shift if necessary. Because we are always there for our customers.
Good reasons for our collaboration
- By working with us, you benefit from our competent network, through which we can conduct studies worldwide.
- Thanks to the large number of performance studies we have already conducted, we can start new studies with a similar design very quickly.
- We offer you a one-stop shop for conducting performance studies. All necessary steps – from planning, qualification of study sites, data collection, statistical analysis, to the preparation of the complete study documentation – are provided as a comprehensive package.
- Through carefully considered selection of suitable study sites, we save you large amounts in your project budget!
The clinical performance study on human specimens according to ISO 20916 on good study practice is the basis for our joint project.
Do you have an IVD for the detection of SARS-CoV-2? Then we additionally use the MDCG 2021-21 guidance for the performance evaluation of SARS-CoV-2 in vitro diagnostics.
Do you have an IVD for the detection of SARS-CoV-2? Then we additionally use the MDCG 2021-21 guidance for the performance evaluation of SARS-CoV-2 in vitro diagnostics.
Our Services
Performance studies are complicated? Not with us.
We are your one-stop shop for conducting various studies.
Upon request, we also conduct studies for medical devices and medicinal products – further details will be published on our website shortly.
We develop the study plan as the foundation of our joint project.
All applications to authorities and ethics committees are handled by us.
We identify and qualify suitable study sites.
We identify and recruit the right participants for your study.
Through electronic data capture, you remain continuously informed.
We monitor study sites as required throughout the course of the project.
Reliable results require robust statistical analysis of raw data – and we provide exactly that for you.
Wir erstellen Ihnen eine vollständige Dokumentation über die Studie.
Project start
From the very first project request through to completion, we rely on standardized processes. This guarantees clear communication and enables highly accurate effort estimations. Prior to each project initiation, all cost items are disclosed and reviewed with you in detail, ensuring that you know exactly which fixed and variable costs to expect at the start of the project.
The following steps outline the typical process from the initial request through to project initiation.
- Receipt of a request
- Internal review: We evaluate the feasibility of the requested project in close consultation with our team and partners.
- Feedback to the client: Depending on the information provided with the request, we either ask for additional details or confirm feasibility and schedule an initial meeting.
- Initial meeting: In collaboration with you, we review your project objectives as well as the relevant legal and regulatory requirements, providing a clear overview of the optimal study design.
- Selection of potential study sites: Based on the agreed study design, we approach suitable sites to request their collaboration.
- In close collaboration with the specialists at each study site, we review the study design in detail to identify opportunities for optimization by incorporating the expertise of all parties involved.
- Should there be opportunities for optimization in the study design, these will be discussed with you and incorporated into the budget calculation.
- Einholen von Kostenabschätzungen der Study Sites: Durch eine enge Kommunikation mit den potenziellen Study Sites holen wir präzise Kostenabschätzungen ein.
- Selection of the most suitable study sites for further calculation: Based on factors such as expected subject throughput per study site, costs, expertise, and others, we select the most suitable locations.
- Creation and provision of the total cost estimate for the project: To provide you with an overview of the expected total costs of the project, we calculate all expected cost blocks for our services, services of laboratories, and other third parties (e.g., transport costs and customs duties).
- Second meeting: In a second meeting, we will discuss the cost estimate with you and the further course of action, such as further adjustments or the start of the project.
If you have any questions or would like to book a service, please feel free to contact us!
Further down the page, you will find an overview of relevant content. There you will find general information on the topic.
Why Choose Us?
Trust
Trust is one of our most important values. That's why we place great importance on the security of your data and only exchange it with you via secure servers in Germany.
Customer Satisfaction
Your satisfaction is our highest goal in all projects. For us, a project is only successful if you are satisfied!
Reliability
Do you need to solve a critical problem at short notice? Together, we can do it – even with an overnight shift if necessary. Because we are always there for our customers.
Request info
One of our consultants will contact you shortly after receiving your inquiry.
Confidentiality and discretion are important to us. Therefore, we will treat your inquiry accordingly, even before we conclude a confidentiality agreement.
