Clinical Research Organization
Why BIOMEX is the right Clinical Research Organization (CRO) for your projects
BIOMEX is the right CRO (Clinical Research Organization) for your projects as we offer a unique combination of expertise, experience, equipment and especially access to Europe’s largest stock of human biospecimens, which sets us apart from the competition. Our team of scientists and project managers have extensive experience in the biotech and pharmaceutical industries and are well versed in the latest industry regulations and guidelines.
In addition, we have state-of-the-art laboratory equipment, our own donation centers, and a broad network of physicians and clinical facilities that enable us to provide a full range of services from planning to sample collection and testing to final report writing.
In summary, BIOMEX is the right CRO for your projects because we have the expertise, experience, equipment and flexibility you need to make your projects a success.
Why you should entrust BIOMEX with your assay validations
We understand that each project is unique and can source rare analytes through our network. We work closely with our clients to ensure their projects are completed on time and within budget.
In addition, we have a proven track record of assay validation. We have helped our customers improve the quality of their products, reduce time, and cost to market, and increase their chances of gaining regulatory approval.
MORE THAN
So why wait? Contact BIOMEX today learn more about how we can help you with your assay validation needs.
Who we are and how we work
At BIOMEX, we are convinced that holistic collaboration with our customers is the best way to optimize project success and thus reduce costs and implementation times. Therefore, we regularly invest in our own dispensing centers, our staff, our laboratories including equipment and continue to expand our network to be able to quickly and reliably process our customers’ requests and lead them to success.
For SARS-CoV-2 rapid assays alone, we have performed more than 155 validation studies for our customers. Additional other assays include various indications or analytes such as HIV, HPV, HCV, HBV, HAV, syphilis, Helicobacter pylori, hemoglobin, bilirubin, urobilinogen, ketone, protein, nitrite, glucose, pH, leukocytes, and ascorbic acid.
With our own donation centers and a donor pool of more than 400 regular donors, we reliably and sustainably supply the samples needed.
Our well-rehearsed team of scientists is at your disposal with their knowledge, expertise and experience.
Our commitment to making your project a success - we are ISO-certified and meet all regulatory requirements.
We are a full-service provider. You receive all services from a single source, saving you time and money.
How we work
We have defined process steps so that we can efficiently reach our goal together
Design phase: A trained specialist will support you in your project and be your contact throughout the quotation, planning and delivery phases. At the beginning of the process, all basic requirements and goals are defined together.
Planning Phase: Your contact person will create an overview of the project process and workflow. He will coordinate with the different members of the study team (such as Sourcing, Laboratory, QM/QC, Regulators, Logistics etc.).
Your contact will be the liaison to the BIOMEX STUDY Team, providing project updates, timelines, and milestones achieved.
Delivery Phase: The project team delivers the agreed results including all documentation and necessary approvals required for the successful launch of the assay.
Frequently Asked Questions
BIOMEX has been conducting studies for clients since many years. Over time, we have successfully completed more than [Anzahl] studies, including….
- [Anzahl] CTS list-A and list-B products
- [Anzahl] Clinical and Layperson studies for Sars-Cov-2 Antigen Rapid Test
- [Anzahl] NPT
- [Anzahl] …weiter ergänzen und ausführen
We are ISO 9001 certified and are currently in the process of obtaining ISO 17025 certification. In conducting studies, Biomex also complies with the requirements of ISO 20916:2019.
BIOMEX has approximately 500,000 blood and plasma samples available in stock. Over 90% of the samples are continuously collected in our own donation centres in Heidelberg, Munich and Cameroon (Africa). In addition, we obtain residual samples via our worldwide network and carry out prospective sample collections upon inquiry.
If you have further questions about the samples used in studies, please look below under "Samples"[QUERVERWEIS]. If you are interested in purchasing samples visit our Sampleshop
Because of our decade-long experience with in-vitro diagnostics, we can support manufacturers with a very extensive repertoire of products and services in the performance evaluation and in obtaining IVDR conformity for their products. The repertoire includes, among others, the following performance evaluations:
| Scientific Validity | Analytical performance | Clinical performance |
|
|
|
|
|
|
|
|
You will find information on the approximate duration of study in the respective offer. The duration can vary greatly depending on:
- the type of study
- the number of tests to be performed according to the chosen guideline
- the availability of swabs/samples
The start of the study depends on the internal capacities at BIOMEX, as well as on the arrival of the test kits and receipt of the prepayment at BIOMEX.
We do not work with any NB as we are an independent, third-party provider and thus need to stay objective. Only when we need to clarify technical requirements, we might contact NBs directly.
a) type of test | b) type of study |
- rapid antigen tests - rapid antibody tests - PCR tests
| - “layman studies” to evaluate the usability of a test when used by a layman - “clinical evaluation” to evaluate the sensitivity and specificity of a test |
Unfortunately, we cannot offer swabs from asymptomatic, positive donors as these are nearly impossible to find. It would require collecting swabs from probably dozens to hundreds of donors and hope that, amongst these, we can find those asymptomatic, positive donors.
For CE application of a “self-use” SARS-CoV-2 antigen rapid test, you will need both studies. But this is only the special part for SARS-CoV-2 tests within the entire performance evaluation you need for a CE application.
Lorem ipsum dolor sit amet, consectetur adipisicing elit. Optio, neque qui velit. Magni dolorum quidem ipsam eligendi, totam, facilis laudantium cum accusamus ullam voluptatibus commodi numquam, error, est. Ea, consequatur.
Study requests can be submitted at any time using the following online form. If for technical reasons it is not possible to submit your study request, you can also specify your study request using this excel file [Datei hinterlegen] and send it to sales@biomex.de. Please attach the IFU of the device to be evaluated, this helps us to check the feasibility of the study required.
To order a study, please sign and return the offer and the service agreement. In the offer you will find initial information regarding the required number of test kits. After ordering, you will receive information on the further procedure, e.g. shipping.
For easier communication with our clients, each study is assigned a unique study number, like L123 or C234.
A public body is a public entity (government institution, regional government office, public hospital) that is primarily state-funded and plays a role in public health.
In Sars-Cov-2 related studies performed by BIOMEX GmbH, the government body is a “Testzentrum”, meaning the test center which can be, for example, a hospital or an official testing site accredited by the German government. In our case, the study is carried out in official testing sites which are located close to or in Heidelberg.
An IRB approval is only required if an invasive sample collection step is performed. This includes, for example, taking blood samples. The taking of swabs, on the other hand, are non-invasive and therefore do not require an IRB approval.
Yes, if this is necessary but we do e.g. have a general IRB approval for providing donor/patient samples for performance evaluation and usability testing of rapid tests in PoCT/NPT. These include some analytes such as Sars-CoV-2, HbsAg, HCV and others and usually only requires the submission of a form with details of your test as an amendment.
BIOMEX sources most of its samples in own donor centers in Germany and operates an extensive sample network and a large warehouse of clinical samples.
We use mostly clinical samples – and spiked samples only when requested as long it is a commonly available analyte.
Nasal Swabs
