PROJECT MANAGEMENT

TRIGA-S offers a comprehensive project management in the field of national and international clinical and technical trials. In addition, we take over the logistics, processing, storage and measurement of biological (human) samples. Tailor-made for your studies, we support you in all phases of preclinical development with our team of international scientists and with our own S2 laboratory. As your reliable partner, we guarantee the absolute correctness, completeness, traceability and validity of the test data and we document this according to applicable international standards.

Our team of experienced scientists will advise and support you:

Planning and conducting international clinical and technical trials according to applicable standards, guidelines and laws:

  • Selection of suitable CRAs and monitoring of all processes
  • Selection of suitable test centres
  • Obtain approval from the competent federal authority
  • Organization and realization of all study-relevant meetings
  • Summary and presentation of the results of the study at relevant conferences

 

Controlled transport and controlled storage of reagents and biological samples (RT, 4 to 8 ° C, -20 ° C and -80 ° C):

  • Patient samples: Delivery and collection, processing and storage
  • Study reagents: Delivery and collection, processing and storage
  • Sample collection and storage for research and development purposes

Development and establishment of study-specific assays:

  • Establishment of study-specific assays in our laboratory
  • Measurement of patient samples directly in our laboratories including the fastest possible transmission of all important study-relevant results
  • Measurement of routine parameters

Documentation:

  • Study Protocol development according to the regulatory requirements / DIN 14155 and DIN 13612
  • Preparation of investigator contracts
  • Creation of Case Report Forms (CRFs, eCRF) and Patient Information / Declarations of Consent
  • Compilation of documentation, application and submission to the responsible ethics commissions and authorities
  • Implementation and preparation of publications
  • Documentation of the clinical data and preparation of the study report according to GCP / ICH
  • Documentation of the laboratory values according to GCP and GCLP