From our extensive biobank to our network of experts, we offer tailored study solutions. From sample collection to the final report – our team of professionals guides you every step of the way. Choose efficiency, quality, and client-centricity. Choose BioVariance.
Customers can take advantage of our comprehensive biobank. Our rich collection of samples from nasopharyngeal and oropharyngeal swabs for respiratory diseases allows a fast execution of retrospective clinical trials. Constantly increasing capacities enable us to conduct high-quality trials also for other fields of application. To ensure and maintain a high sample quality, samples are frozen in viral deactivation buffer at – 80 °C.
If the biobank does not fulfil your need or your wish regarding a prospective study, we can draw on our wide network of numerous medical specialists, practitioners, and hospitals to collect new customized samples. This advantage enables us to conduct studies with various measurement parameters as well as different kinds of swabs and sample types.
The samples will be transported in cooling boxes by a partner company to ensure sample quality by a continuous cooling. After finishing the study, the samples can be transported to your own storage capacities.
With our broad experience in the execution of clinical trials with self-tests or POC devices, we can support you with the trial design and regulatory questions. You do not want to write the trial protocol on your own? We can write your trial protocol and discuss the several kinds of tasks being very important for you and necessary for a successful certification. After the design process, you can adapt and approve our proposed trial protocol and we will conduct the study based on the adapted protocol.
A study can be separated in various tasks. The most common one is a statistical evaluation against the gold standard method, meaning a qPCR measurement, an analysis with a LC-MS or an immunoassay, for example. These various measurement possibilities allow us to cover many fields of studies. We can also offer you to examine your tests or devices regarding other important topics like cross-contamination, cross reactivity, or the detection of the limit of detection (LoD). Furthermore, our service comprises the conduction of spike-in experiments with standard solutions and the examination of the stability of your reagents. Before starting an experiment, the experimental plan is discussed with the customer to ensure the production of high-quality results and to reduce time delays and experiment failures. We offer the possibility of processing pre-testing or pre-studies. All deviations from the trial protocol will be communicated to our customers and noted in the trial report.
Many medical devices allowing self-testing at home without the support of medical employees require layperson studies. For this, a specific number of laypersons tests the device at home for a fixed time and reports the handling experiences to us, giving us a good overview of the performance of the device in a realistic environment. We undertake the design and conduction of the study as well as the evaluation of the completed questionnaires of the laypersons, thus helping our customers to obtain the targeted certification of their product and to detect optimization possibilities for an easier and more customer-oriented design.
The results of all parts of the study will be combined in a final report, which fulfils regulatory standards and includes all necessary documentation and clearly structured raw material. The measurement results will be evaluated regarding the statistically relevant calculations like sensitivity, specificity, or accuracy. All reports are adapted to our customer’s wishes. The studies will be supervised by qualified personal with a background in both, natural sciences as well as laboratory matters.
BioVariance serves with the unique possibility to execute all parts of a clinical trial within only one company. This enables us to process different kinds of trials in a customer oriented and efficient way without wasting time or resources. Our team of biologists, data scientists and technical assistants will guide you through the entire process of the study, starting with the trial protocol, and ending with a complete report, which is ready to be submitted to the relevant authorities. With our hands-on mentality, we can tackle possible challenges during the study process quickly and always oriented on the needs of our customers.