IVD TRIALS – Your German experts for performance evaluation studies

IVD TRIALS – Your German partner for high-quality trials

With our expert team and numerous test systems, we perform the entire validation process for you at our own facilities.

Take advantage of our extensive know-how in analytical and clinical validation, compliant with the EU IVDR, WHO, TGA or Chinese NMPA.

See our services SEE OUR FAQ

For you, this means:

Rest assured: You are working with professionals
Highest quality at a reasonable price
The best chances for an approval of your assay

Getting your ivd approved

Are you looking to validate your IVD products according to EU IVDR?

This is why our experts guarantee the best chances for an approval of your assay:

100% in-house expertise, no freelancers or subcontractors

direct access to more than 900,000 human biospecimens in stock as part of the German MEX Group

proven record from more than 250 successful clinical IVD trials at highest quality levels

Our services

Our study offerings include clinical and analytical performance evaluations for all major methods such as PCR, rapid tests and immunoassays (CLIA), including usability studies, e.g. laymen studies (self-testing), and near patient testing (PoC, Point-Of-Care).

Comply with all regulatory requirements such as European IVDR, Chinese NMPA, Australian TGA or WHO regulations.

What sets us apart SEE OUR FAQ

Analytical performance is the basis for the clinical performance of a device and focuses on the analyte. Indicators of analytical performance are typically similar or even identical across IVD devices, and a number of Clinical & Laboratory Standards Institute (CLSI) documents provide guidance. IVD TRIALS offers studies for several scenarios, including:

Endogenous and exogenous interference, e.g., CLSI EP07-A2, as well as cross-reactivity, e.g., CLSI EP07-A2

Limit of Detection (LoD) for qualitative and quantitative tests, e.g., CLSI EP17-A2, Limit of Quantification (LoQ) for quantitative tests, e.g., CLSI EP17-A2, and Limit of Blank (LoB) required for quantitative tests and not listed in the IVDR, e.g., CLSI EP17-A2

Measuring range for qualitative and quantitative tests
Linearity for qualitative and quantitative tests, e.g., CLSI EP06A
Cut-off for qualitative and quantitative tests, e.g., CLSI EP24-A2
Trueness (bias), e.g., CLSI EP06-A or CLSI EP09-A3
Precision (repeatability and reproducibility), e.g., CLSI EP05-A3
Accuracy, resulting from trueness and precisions, e.g., CLSI EP21-A
Validation of specimen collection
Hook effect for immunological tests for qualitative tests – for quantitative tests it will be already included when measuring the range
Sample stability evaluation (freeze/thaw cycles, matrices, specimen type), e.g., CLSI EP25-A
Shipping and transport stability (only accelerated study)
Shelf life (only accelerated study)
Robustness studies (flex studies)
Carry-over/cross-contamination for multiple use devices, e.g., CLSI H26-A2

A clinical performance study focuses on the patient. Depending on your product, demonstrating clinical performance may require different types of studies. IVD TRIALS offers studies for several scenarios, including:

Clinical performance studies are to establish or confirm aspects of device safety and performance which cannot be determined by literature and/or previous experience gained by routine diagnostic testing.

Near-patient-testing or point-of-care testing means carrying out a test by healthcare professionals in hospitals or in physicians’ offices using a device in the presence of the patient without the need to send a sample to a laboratory.

Products that are to be used by laypersons for self-testing must comply with certain specifications, e.g., in terms of safety, applicability, and significance of their results.

What sets us apart

We understand the unique requirements of your project. This is why we will provide you with exceptional support and resources.

Unlike many other CROs, we offer a full service:

steps of your study SEE OUR FAQ

For you, this means:

Daily prospective collections in own donation centers with hundreds of donors. Precise sourcing of samples for your study
Large L2 and L3** lab facilities that allow us to work with specific risk group 3 pathogens such as SARS-CoV-2 or HIV
Access to Europe’s largest commercial inventory of human biospecimens as part of the German MEX Group, as well as a worldwide samples network. This enables us to source for you a wide range of clinical samples, such as dengue or chikungunya samples from newly infected patients, all HIV subtypes, or progression samples from Lyme disease patients
Study design, ethics approval, study performance, data analysis, and the final report, all included at the highest quality levels
A quality management system that is accredited to ISO 9001 – all studies are performed in accordance with ISO 20916:2019 and ISO 14155; currently, we are working on obtaining ISO 17025 certification for our laboratories

How we conduct your study – together with you

Your requirements

Use our easy-to-use standard questionnaire to define your study.

Expert check #1

Our sales team will check the general feasibility of your project. If we do not feel confident, we will neglect your inquiry.

Meeting

In an online meeting – or in person at our German headquarters – we will discuss your project together with you.

Expert check #2

Afterwards, our experts will check the detailed feasibility of your project, the capacity of staff and infrastructure, and the availability of all samples.

Pricing

Typically after 2-10 working days, you will receive a pricing indication for your inquiry.

Your offer

Once confirmed from your side, we prepare an official offer and service contract for you to sign.

The start of your study

Our team works hard to get your IVD approved!

FAQ

Frequently Asked Questions:

Do you have any further questions? We are happy to assist you via e-mail, phone or let’s have an online-meeting.

All main facilities are conveniently based in Heidelberg, Germany, one of Europe’s main biological research hubs. Heidelberg is only a one-hour drive or train ride from Germany’s largest airport in Frankfurt am Main.

Among other things, the following benefits set us apart from other CROs and give us the ability to conduct your performance evaluation study with maximum flexibility and quality:

Sample collection in our own donation centers – prospective and exactly tailored to your specific requirements
100% value chain in-house, including expert regulatory support, study design, ethics approval, testing in our own labs, material handling and external site management
Access to Europe’s largest commercial biospecimen inventory

We started to deliver performance evaluation studies for in vitro diagnostics in 2017. Since then, we have supported numerous manufacturers by conducting hundreds of performance evaluation studies.

We collect 90% of samples through our own donation centers in Heidelberg, Munich and Cameroon (Africa). Our sister company BIOMEX ’ inventory holds over 600,000 biospecimens for you: Plasma, Serum, Swabs and Tissue. For more information, please visit the BIOMEX Sampleshop.

In addition, we constantly obtain residual samples via our worldwide network and carry out prospective sample collections for you upon request.

We operate laboratories that allow us to work with samples of biosafety level 3. These include, for example, HIV, HCV, or SARS-CoV-2.

In addition to standard laboratory methods, we offer various tests such as PCR, clinical chemistry, CLIA/CMIA, POCT and more. Our equipment includes:

Company	Instrument
Roche	Cobas e411
Roche	Cobas c501
Roche	Cobas 5800
Abbott	Architect i1000SR
Diasorin	Liason XL
BioMérieux	MiniVidas
ThermoScientific	Quantstudio 5
Bio-Rad	CFX96 (x2)

Of course. We maintain an “open door policy” and are happy to show you our infrastructure on site.

In addition to clinical and analytical performance studies, you can work with us to evaluate near-patient testing (NPT) / Point-of-care testing (POCT), self-tests for laypersons, and CLIA assays:

Company	Instrument
Clinical performance evaluation studies	We operate our own donation centers. This enables the sourcing of positive and negative samples for the evaluation of diagnostic sensitivity and specificity, as well as for the majority of common analytes.
Analytical performance evaluation studies	We perform full validation studies for IVDs (qualitative or quantitative) according to the relevant CLSI guidelines. This includes analytical sensitivity (limit of detection, limit of quantification), analytical specificity, stability of the assay or sample, trueness, precision, accuracy, linearity, measuring range, and cut-off value.
Laymen studies, Near-patient testing / Point-of-care testing	Through our own test centers, we can effectively recruit lay people to participate in usability/laymen studies or NPT/POCT studies.
Studies for the validation of CLIA-assays	Our infrastructure is capable of performing tests with class D IVDs (e.g., HIV) as well as class C and B IVDs in accordance with the EU common specifications. We have dedicated facilities and instruments for reference testing to routinely perform these validation studies in-house.

Yes, in contrast to many other CROs, we offer a full service that includes study design, all related consultations by our experts in the field, sourcing and preparation of all necessary samples, in-house testing in our own laboratories, and data analysis and preparation of the final report.

Please contact our sales team. Our experts will guide you through our standardized inquiry process.

The study duration depends on several factors, such as the type of the study and the sample, the sample size, the time required for collection (for example, incidences and seasonal events have a large impact on prospective sample collection), the time required for IRB approval, and the time to set up your study. Thanks to our many years of experience, we can usually provide an estimate in advance.

We generally do not conduct research on scientific validity unless it is commissioned as part of a larger package that includes scientific validity, analytical performance, and clinical performance.

Yes, in addition to our large biobank of retrospectively collected samples, we have facilities and infrastructure to collect fresh biospecimens for your study. This includes recruitment of participants and obtaining approvals from the institutional review board (IRB).

Depending on study requirements, we may collect the usual clinical information of each donor, e.g., age, sex, time/date of sample collection, initial diagnosis, symptoms and date of symptoms onset, information regarding contact with infected persons and/or vaccination status, ICD code (provided this does not interfere with sample anonymization requirements). Prospective collection of non-anonymized samples is also possible with the involvement of clinical cooperation partners after submission of a positive ethical vote.

We are a strong partner for all IVDR (European Union), TGA (Australia), NMPA (China) and WHO guideline applications. We do not offer studies (especially clinical) for FDA (USA) applications.

We do not specifically advise or assist in the selection of the Notified Body, but will be happy to refer you to one of our trusted partners. Please inquire at our sales team.

We do not act as a legal representative but will be happy to refer you to a trusted partner of ours. Please inquire at our sales team.

Our business activities are determined by the wishes of our customers and the legal requirements, and are guided by responsibility towards society and the environment. We produce and supply high-quality products at the cutting edge of science and technology and provide a high level of service. Our premise is reliability and customer-oriented action. We strive to avoid errors instead of subsequently correcting them. The requirements of our quality management system are always met, and we continuously improve its effectiveness.

Our quality management system is accredited according to ISO 9001. All studies are performed in accordance with ISO 20916:2019 and ISO 14155. Furthermore, we are currently in the process of obtaining ISO 17025 certification for our laboratories.

Yes, for both invasive and non-invasive clinical sample collections.

For non-invasive testing, we have ethical approval for participants 14 years of age and older. For invasive testing, we have ethical approval for participants 18 years of age and older. If ethical approvals are required for participants younger than the available IRB, these can be applied for.

The European In Vitro Diagnostics Regulation (IVDR) came into force in May 2017, replacing the previous In Vitro Diagnostics Directive (IVDD) in May 2022 after a five-year transition period. Until May 2027, the specifications will gradually become valid for the individual product risk classes.

Scientific validity means that an analyte is associated with a specific clinical condition or physiological state (IVDR, Article 2 (38)).

Analytical performance refers to the ability to correctly detect or measure a specific analyte (IVDR, Article 2 (40)).

Clinical performance describes the ability to provide results that correlate with a specific clinical condition or physiological or pathological process or state (IVDR, Article 2 (41)).

In order to assess the performance of a device before it is placed on the market, manufacturers must identify all available data on the device, its intended use and safety, and fill in data gaps. Unanswered questions require the performance of appropriate studies (IVDR, Annex XIII, Part A, 1.2).

After market introduction, manufacturers should proactively collect and evaluate performance and scientific data resulting from the use of the device to ensure safety, performance and scientific validity throughout the lifetime of the device and to identify any risks (IVDR, Annex XIII, Part B, 4).

What our customers say:

„Thanks to the professional support of IVD TRIALS,
this comparative study was a great success.“ – finddx | Diagnosis for all

„Our Focus:Getting YourIVD Approved!“