Biorepository and laboratory services

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BIOREPOSITORY

It is well known that pharmaceutical or biotech companies needs biologic material of any kind for the preclinical part of any clinical study, to perform preclinical tests, to test different new molecules on different biologic substrate such as bacterial strains, peripheral blood or other biologic fluids, PBMC or other types of isolated cells, etc.

We are able to develop entire process of biospecimen collection, starting with approval from regulatory bodies, developing the informed consent for the patient, identifying the specialists having the required patient population, willing to donate the material for the general benefit of the clinical research process where its material is required for further testing. Our lawyers are always up-to-date with the international legislation regarding biologic samples collection and repository process and all study documentation is developed by respecting GCP and latest GDPR requirements.

We have capacity to collect, store and process this material for your needs!

LABORATORY

Clinical laboratory is an important actor in the developing of any clinical trial, even if we speak about a local or a central lab. It is mandatory to understand that for instance, for an oncologic clinical trial, the investigator must have quick access to the results of the patient, in order to administer the study medication or not. The selecting process of a competent laboratory is not an easy task and does not mean only to gather documentation such as certificates or other accreditations. Our team of laboratory experts have more than 50 laboratory audits, system or study specific audits, where the quality management system, GCP and GCLP have been verified and are in place.

Our experts provide you the necessary knowledge and practical experience for following activities:

  • sampling kit design
  • selection and qualification of a laboratory for study specific testing
  • developing and validating of a new laboratory method
  • supply chain of sampling kits to sites
  • project and data management

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We work not to prove, but to improve!