TRIGA-S Scientific Solutions

www.triga-s.de

Your diagnostics studies in good hands: TRIGA-S is a full-service Contract Research Organization (CRO) addressing the unique needs of in vitro diagnostics (IVD), companion diagnostics (CDx) & medical device.

About us

TRIGA-S stands for excellency and highest quality in clinical and technical studies for more than 20 years and is a preferred service partner of global diagnostic companies.

Within the framework of the new IVD- and Medical Device-Regulation (IVDR/MDR), we offer tailor-made solutions for analytical and clinical performance evaluations:

  • BSL2 Contract Laboratory

  • Sample Collection, Processing and Storage

  • Study Management

  • Clinical Monitoring

  • Biostatistics

  • Data Management

  • Regulatory Affairs

  • Study Logistics

Address
TRIGA-S Scientific Solutions
Muehltal 5
82392 Habach
Germany

Phone: +49 8847 695780
Fax: +49 8847 6957829
Internet: www.triga-s.de

Contact person

Karolina Heed
Business Development Manager
Phone: +49 8847 695780

Products and services

Clinical & Technical Studies:

  • Analytical performance evaluation - IVDR/FDA requirements

  • Clinical performance evaluation - IVDR/FDA requirements

  • Clinical sample collection study

  • Companion Dx study

  • Feasibility study

  • Exploratory study

BSL2 Laboratory Testing Services:

  • Automated testing >200 parameters with e.g. ECLIA

  • ELISA and Real-time PCR  testing

  • Pharma interference testing

  • Point-of-care (POC) testing

  • IVD medical device testing

  • Application work (extended workbench)

Sample Management:

  • Sample sourcing and processing

  • Sample pool preparation

  • Sample aliquotation

  • Sampling kit assembly

  • Sample logistics

  • Sample storage

Individual Services:

  • Clinical study management

  • Clinical study monitoring

  • Biostatistics

  • PMPF (Post-Market Performance Follow-up)

  • Regulatory consultation

  • Study material logistics

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