FDA's Expedited IND Pilot Program lets a drug sponsor pair with a Qualified Research Institution (QRI) so FDA can review IND components on a rolling basis instead of waiting for one complete submission. Sponsor-QRI pairs have until 11:59pm ET on October 30, 2026 to apply, and FDA expects to select roughly 8 to 10 pairs and notify applicants by December 18.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Pre-launch readiness
1 site activated
1 form not yet approved
Oct 30, 2026
deadline for sponsor-QRI pairs to apply, 11:59pm ET
8-10
pairs FDA expects to select for the first cohort
Dec 18
date FDA notifies applicants of selection
Rolling
FDA review of IND components as each is completed
The pilot
Launched under HHS's Operation Trialblazer, the pilot lets FDA accept and review individual components of an IND application on a rolling basis as a sponsor and a partnered Qualified Research Institution complete them, instead of reviewing one complete submission all at once. FDA has said it is aiming the pilot at early, first-in-human development, where a faster path to Phase 1 has the biggest effect on a program's overall timeline. Confirm eligibility, conflict-of-interest requirements and the application process directly on FDA's own program page before you apply.
protocol_v3.pdf
Draft study
Timeline
Dates as publicly announced by HHS and FDA. Confirm current status on FDA's own program page before relying on it.
HHS launches Operation Trialblazer, a department-wide effort with FDA, NIH, ARPA-H and OIG to speed up US clinical development.
FDA opens the Expedited IND Pilot Program and begins accepting Sponsor-QRI applications.
Applications close at 11:59pm ET. Sponsor and QRI apply together, as a pair.
FDA notifies all applicants whether their pair was selected for the pilot cohort.
Before you apply
Identify a Qualified Research Institution with the scientific expertise your IND needs; sponsors and QRIs apply as a pair.
Rolling review works best when nonclinical, CMC and clinical protocol sections are ready as each is finished, not all saved for the end.
FDA's application asks about conflicts of interest between the sponsor and the QRI; confirm this before applying.
The faster your study can move from protocol to a live, auditable data capture system once selected, the more of the pilot's time savings you actually realize.
Once you're in the pilot
The pilot buys you time on IND review. It does not help if the study behind it still takes weeks to stand up. Capture's AI study builder reads an uploaded protocol and drafts the visit schedule and forms directly from it, so a first-in-human study can move from protocol to a testable, auditable build in the same sandbox you would use to prepare for the pilot itself.
Question form
CRF or ePRO
Lab table
Analytes, units, ranges
1. Systolic blood pressure
Required · Number · mmHg · 0 dp
2. Diastolic blood pressure
Required · Number · mmHg · 0 dp
3. Pulse rate
Required · Number · beats/min
4. Body temperature
Required · Number · °C · 1 dp
5. Position during measurement
Required · Sitting, Supine, Standing
Before you switch
Free sandbox with every feature, no credit card, so you can build and test before your IND is even filed.
Field-level audit trail and OTP-verified e-signatures from your first entry, with documentation to support sponsor validation on Enterprise.
AI drafts the visit schedule and forms from your protocol; you review before anything is saved.
Bring an existing protocol or CRF set across; the AI reads PDF, DOCX and DOC files.
Email support, typically under 24 hours, plus documentation and implementation assistance on Enterprise.
Free sandbox with every feature. No credit card, no sales call.
A pilot under HHS's Operation Trialblazer that lets a drug sponsor pair with a Qualified Research Institution so FDA can review IND components on a rolling basis instead of one complete submission. Confirm eligibility and process directly on FDA's program page.
No. Capture is not affiliated with FDA, HHS or this pilot. This page explains the publicly announced program and where Capture's own features, like AI-assisted study building and a full audit trail, support the operational side of running the study once your IND is underway.
FDA has stated the deadline for sponsor-QRI pairs to apply is 11:59pm ET on October 30, 2026. Confirm this directly on FDA's own program page before your deadline planning.
FDA has said it expects to select roughly 8 to 10 pairs for the initial pilot cohort and notify all applicants of selection decisions by December 18.
FDA's program pairs a drug sponsor with a QRI, a research institution with the scientific expertise to support an efficient IND submission. Check FDA's program page for the specific eligibility criteria.
No. The pilot changes how your IND application is reviewed, not what a validated data capture system needs to provide. You still need the same audit trail, e-signatures and access controls either way.
Yes. The free sandbox includes every feature with sample data, no credit card and no time limit.
Keep exploring
FDA Operation Trialblazer guide
The broader HHS initiative this pilot sits under.
EDC for First-in-Human (FIH) Studies
The study type this pilot is aimed at.
ICH E6(R3) guide
The GCP guidance running alongside this pilot.
CRF builder for clinical trials
The AI drafting that speeds up an IND-ready build.
21 CFR Part 11 compliance checklist
What to verify regardless of the review track.
Free sandbox with every feature. No credit card, no sales call.