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14th April 2020  Content supplied by: TRIGA-S Scientific Solutions

TRIGA-S Helps COVID-19 Diagnostic Manufacturers Fast-track Regulatory Approval


In response to the COVID-19 crisis, we are experiencing an impressive effort by diagnostics manufacturers to develop tests for different clinical settings and purposes. Under the current circumstances, regulatory authorities, e.g. FDA and BfArM, grant emergency authorization, requiring clinical evidence for test specifications, such as sensitivity and specificity. We at TRIGA-S are well prepared to support IVD manufacturers with the necessary analytical and clinical study services in order to achieve quick market entrance for their assays. Our services also include the procurement and management of clinical samples (e.g. nasopharyngeal swabs , serum and plasma) as well as full material and study logistics worldwide.

TRIGA-S services:

  • Analytical performance evaluation in our S2 laboratory.
  • Clinical study management and monitoring (also multi-site).
  • Sample logistics, processing and short-/long-term storage.
  • Design of IVD trials, evaluation & feasibility studies.
  • Biostatistics
  • Regulatory consulting
  • Post-Market Surveillance

 

TRIGA-S at a glance:

  • Headquartered in Habach, Munich south, Germany, with 1600 mfacilities: S2 contract laboratory (GCLP), office and storage space.
  • 90 highly skilled employees (PhD, MSc, BSc, technical staff).
  • Measurements on a wide range of platforms for clinical chemistry, immunology, ELISA and PCR​.
  • Fast and efficient study turn-around; managed >500 study sites worldwide, a large number of different studies, and >1 million samples.
  • Preferred service provider of global diagnostic companies.

    

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Date Published: 14th April 2020

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