I built OSSICRO, open-source software that assembles the FDA regulatory package a physician needs to get an investigational drug to a single patient through the expanded-access pathway, FDA Form 3926. From the patient's intake it drafts the eight required documents, stamps every field back to its source, checks each one against the regulation that governs it, computes the statutory clocks, and assembles the filing. I'm a physician. This is the wall I wanted gone. OSSICRO produces drafts and refuses the non-delegable acts: consent, IRB judgment, causality, signing, submitting. Its micro-CRO layer won't even draft a transfer of informed consent to a CRO, because that obligation is non-delegable under 21 CFR Part 50. Four independent parties own the four real decisions, and the software itself owns none of them. I aim to help create an ecosystem around this platform that will allow patients the freedom to particpate in clinical trials with the support of their known physician. This system aims to streamline the whole process, end to end, with appropriate regulatory safeguards. Why it matters: standing up a compliant single-patient pathway costs a physician months of work and tens of thousands of dollars in CRO fees, so most give up. OSSICRO makes the coordination cheap and the paperwork correct. It is a governed, cited tool that runs with one command, and it never pretends to make the calls a clinician and an IRB have to make.
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