Rivka Zaibel

3 Views From Inside FDA's RTCT Pilot The FDA's RTCT pilot promises to bring clinical trials into the real-time era, but questions remain about governance, oversight, and implementation. We asked three organizations participating in the initiative what they see as the opportunities, challenges, and realities behind the FDA's most ambitious modernization effort in years. Capture Was Step One.

By Rivka Zaibel, ADRES Bio The companies that struggle most after a Form FDA 483 is issued are often not the ones that lack words. They are the ones that lack control. That is what the FDA’s March 2026 draft guidance makes clearer than before. The document does not create a new legal standard, and it is still a draft and nonbinding.

By Inbal Hacmon and Rivka Zaibel, ADRES Bio In the evolving landscape of clinical research, the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines serve as the cornerstone for ensuring the ethical and scientific quality of clinical trials, safeguarding the rights, safety, and well-being of trial participants.