Comment from Concordare Trials, Inc.
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Summary: Concordare Trials, Inc., a clinical trial technology company, supports the Expedited IND Pilot Program and advocates for the use of structured, machine-readable protocol data to achieve the program's parallelization goals. They recommend specific technical criteria for Qualified Research Institutions (QRIs), including standards alignment with ICH M11 and CDISC USDM, and offer to share operational data and participate in technical discussions.
Concordare Trials, Inc. respectfully submits the attached comments on the Expedited IND Pilot Program (Docket FDA-2026-N-4699). The full comment is attached as a PDF.
Summary: The pilot's goal of running IRB review, site contracting, and site activation in parallel with IND development depends on shared, structured protocol data. We recommend FDA (1) add a data and technology readiness criterion for QRIs (A.1.i); (2) prefer structured, machine-readable, standards-aligned submission artifacts with provenance and human sign-off (A.2.ii); (3) expect QRI infrastructure that maps to ICH M11 and CDISC USDM and exports to existing site systems (A.5.i); (4) capture a minimum structured, timestamped metric set rather than relying on self-report, and define success by time, quality including clinical-hold rate, and safety metrics (B.3); and (5) treat a structured protocol representation as foundational infrastructure and align the platform to existing standards rather than a bespoke format (C.1, C.4). We offer measured operational results from a live academic health-system deployment and offer to share validated data and participate in technical discussions.
Signed: Zach Sawaged, Founder and CEO, and Alex Butler, MD, MS, Chief Medical Officer, Concordare Trials, Inc. (New York, NY). Contact: zach.sawaged@concordaretrials.com.