Consulting
Expertise: Consulting 228 results
Recent regulatory developments are reshaping how sponsors think about evidence, oversight, and operational readiness. In a New England Journal of Medicine Sounding Board, FDA leadership announced that one adequate and well-controlled clinical trial — supported by confirmatory evidence — could become the...
In our recent blog examining the FDA’s move toward a one pivotal trial approval pathway, we explored what this shift means for clinical strategy, regulatory engagement, and evidentiary rigor. As development programs concentrate approval decisions into a single adequate and well-controlled study, the implications extend well...
In February 2026, the Food and Drug Administration (FDA) outlined a meaningful evolution in the Agency’s evidentiary approach to drug approval: establishing one adequate and well-controlled trial, supported by confirmatory evidence, as the default basis for marketing authorization. This position...
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ISCDD International Meeting
Consulting
ASCPT 2026 Annual Meeting
Clinical Development
COG UK
The Trial Master File (TMF) has long been a cornerstone of clinical research, serving as the primary record of study oversight, documentation integrity, and adherence to GCP standards. As modern programs grow in scale and complexity—often spanning multiple regions, partners,...
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RAPS 2nd Annual Kick Off Gala
Consulting
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