COVID-19 And Clinical Trial Regulatory Guidelines

By Jim Murphy, CEO, Greenphire

Within the past week, both the FDA and EMA issued guidance with regards to the conduct of clinical trials during the COVID-19 pandemic.

This swift action taken by the regulatory agencies was in direct response to global concerns around assuring the safety of clinical trial participants, maintaining compliance with good clinical practice (GCP) and minimizing risks to trial integrity during this unprecedented time.

These latest regulatory guidelines permit sites, sponsors and CROs to adjust their study operations to meet changing conditions for ongoing trials, however there are conditions that must be met in order for new solutions to be considered.

Here are six steps the industry can take to support the needs of patients and sites.