Your partner for the successful conduction of clinical and analytical performance studies with own BSL2-laboratory.

The entirety of our various services is the basis for IVD solutions that are tailored to our client’s needs: The laboratory and technological know-how combined with decades of clinical trial management experience are the key to achieve our common goals. 

TRIGA-S stands for excellent quality and trustful collaboration. The requirements of our clients determine our thoughts and actions.  

We contribute to our client’s IVD development success with our flexibility, cost-efficiency and transparency combined with regulatory compliance and versatile experience. 

TRIGA-S is certified according to ISO13485, our processes comply with pertinent guidelines such as GCP/GCLP, CLSI, or ISO 20916. 

Get in touch with TRIGA-S if you want to learn more about our services and tailormade solutions.  

The duration and costs of a study depend to a large extend on the: 

• study design / objectives and endpoints of the study 
• complexity of the IVD candidate and it’s intended purpose 
• number of study participants to be recruited 
• number of required human specimens 
• number of study sites 
• regulatory requirements 
• study category (interventional, observational, low/high risk) 
• prevalence of the indication of interest 

As every study has its own characteristics, a generalization of timelines and costs is not possible – yet there are some indicators. 

• Analytical performance studies (aPS)  

• aPS usually have a shorter duration, ranging from a few weeks to a few months, depending on the specific parameters and experiments being evaluated and the complexity of the assay.  
• Costs for aPS are often lower compared to clinical performance studies 

• Clinical performance studies (cPS) 

• cPS are often more time-consuming and may span from several months to several years. 
• cPS are more expensive due to patient recruitment and site management. A budget will typically include expenses related to patient recruitment, site fees, laboratory tests, monitoring, and data management. 

Get in touch with TRIGA-S if you need help in conducting a thorough cost estimation and budget planning before starting your studies. 

As TRIGA-S focuses on study services, TRIGA-S does not offer laboratory routine measurements (usually offered by medical laboratories, e.g. according to ISO15189). 

However, as TRIGA-S runs a Biosafety Level 2-laboratory (BSL2), we can offer various other laboratory-based services. For more information, please refer to the following topics: 

• Specimen collection @ TRIGA-S 
• Contract laboratory @ TRIGA-S 
• Laboratory instruments @ TRIGA-S 
• Technological experience @ TRIGA-S 
• Sample storage @ TRIGA-S 
• Sample processing and small volumes @ TRIGA-S 
• Kit assembly for sample collection @ TRIGA-S

IVD performance studies in most cases require samples to be measured.  It is often difficult to get hold of these valuable samples. Here are some common strategies: 

1. Collaboration with Healthcare Facilities such as partnerships with hospitals, clinics, and healthcare facilities to obtain patient (left over) samples. 
2. Acquisition from Biobanks and Tissue Repositories / Retrospective Sample Collections. 
3. Prospective Sample Collection – classical clinical IVD studies: Design and conduct prospective clinical performance studies where participants are recruited specifically for sample collection according to the CPSP. As an advantage, this allows to collect samples according to predefined inclusion and exclusion criteria. 

Ethical considerations: It is essential to ensure that sample collection procedures comply with ethical principles and regulations. This includes obtaining informed consent from participants, protecting patient confidentiality, and maintaining the privacy and integrity of the collected data. 

We develop project offers hand in hand with our clients and consider all necessary information. We calculate realistic offers to avoid additional change orders during the runtime of the project. This ensures a proper and realistic timeline as well as  budget planning