By mid December on the trial progression;
- should have taken receipt of the trial medication and part of that consignment set aside for stage 2 & 3 of the drug registration 'batching / shelf life' compliance program should be underway ( stage 2 completed and compliance met)
- the 'discrete data package' build should be well underway and programmed around the trial delivery timeline with the outcome structured to meet the interim data outcome analysis aligned to TGA / FDA risk/benefit compliance
- will be prepping the 2024 trial recruitment screening and the ISI questionnaire and the additional severity screen compliance document to weed out those who don't meet the severity score required.
- establishing and locking the final trial sites for the 519 to attend.
plenty to keep watch for
red or black.
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