Quality Aspects of Working in a COVID Environment | Rephine Symposium 2021

Topic: Biopharmaceuticals, Manufacturing

Covid-19 has been both an obstacle and an opportunity for clinical trials.  Many trials in the Covid-19 indication were initiated in 2020 that required thinking out of the box in order to assure that the trials could be run and monitored in the new reality, and yet comply with GCP.

Different examples are presented from the experience of Ognyan Nikolov, QA Manager from auditing and advising for Covid-19 projects run in Bulgaria, North Macedonia and Romania:

  • Availability and definition of source data
  • Organizing remote monitoring while preserving direct access to the data
  • Auditing and inspection of a trial in a Covid-19 restricted environment
  • The reality of cloud data storage and its compliance with GCP and data protection regulations
  • Communication with regulatory bodies and other government agencies
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