Conducting a clinical trial during the pandemic? Here’s what you need to know from the FDA’s updated guidance.

The US FDA today issued updated guidance to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency.

The guide goes further within an appendix explaining general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 pandemic.

Available to download directly from the FDA here: https://lnkd.in/eqtXVKi the guidance is non-binding and provides recommendations rather than law, with the objective of ensuring the continued safety of trial participants. Sponsors are encouraged to consider each circumstance, focusing on the potential impact on the safety of trial participants, and modify each study conduct accordingly.

It’s clear that choosing a pharma partner who is alert, aware, professional, and fluid enough to adjust to the unpredictable daily developments is paramount. Contact us today to discuss your clinical testing needs or to find out more.

Additional News

  • 19 December 2023

    Happy new year 2024

    As we bid farewell to 2023, it's time to express our deepest gratitude for the collaboration.

  • 4 December 2023

    Our new clinical unit in Ostrava comes to life

    It's a great pleasure to announce that after two years of hard work, the brand-new clinical unit in Ostrava with 36-beds capacity has been opened.

  • 3 October 2023

    Meet us at the heart of Pharma, CPHI 2023

    Quinta-Analytica is attending CPHI 2023 in Barcelona