A small biotech needed an informed consent form (ICF) for an IND submission, with limited lead time following agency feedback. The challenge was compounded by a lack of prior materials and an untested template.

Synterex’s Solution:
AgileWriter™ was pretrained using draft sources and updated incrementally as new protocol information became available. The model’s output was so robust it was also leveraged to produce a pregnant partner ICF for the same study.