Concordare Submits Public Comment to FDA on the Expedited IND Pilot Program
On July 22, 2026, Concordare Trials submitted a formal public comment to the U.S. Food and Drug Administration on its proposed Expedited Investigational New Drug (IND) Pilot Program (Docket FDA-2026-N-4699).
The pilot aims to shorten the time from drug identification to first-in-human study. It would establish a network of Qualified Research Institutions, introduce a rolling IND submission process, and test whether trial-initiation activities such as IRB review and site contracting can run in parallel with IND development rather than one after another.
Our core point: parallelization runs on data
In our experience, the binding constraint on running these steps concurrently is not willingness but data. Today the same protocol information is re-extracted and re-transcribed by hand at each stage, so the steps queue rather than overlap. When the protocol exists once as a validated, machine-readable representation, IRB packages, site-facing worksheets, eligibility checklists, and system configurations can be generated at the same time. We recommended the Agency treat a structured protocol representation as foundational infrastructure for the pilot's parallelization goal.
What we recommended to FDA
- Add an explicit data and technology readiness criterion for participating institutions.
- Prefer structured, machine-readable submission artifacts, aligned to existing standards (ICH M11 and CDISC USDM), with clear provenance and human sign-off.
- Capture a minimum structured, timestamped metric set during the pilot instead of relying on staff recollection.
- Align the pilot platform to existing standards rather than a bespoke format, so participants build once and keep using it after the pilot.
Grounded in operational results
We shared measured operational data from a live deployment, where structuring the protocol once and generating downstream outputs from it reduced manual source-document drafting from an average of 13.3 hours to roughly 16 minutes per study. We presented those measured results alongside clearly labeled targets still being validated, and offered to share de-identified data with the Agency to inform the pilot's success metrics.
The recommendation is consistent with the Department of Health and Human Services' own Operation TrialBlazer roadmap, which observes that clinical trial protocols are written as unstructured documents, making it difficult to automatically screen patients for eligibility, validate submissions, or reuse protocol logic across systems.
The comment period is open through August 24, 2026. You can read our full comment here: https://www.regulations.gov/comment/FDA-2026-N-4699-0058
