A Complete Response Letter costs 12 to 18 months. Most submission gaps are findable before you file.
Sutra Regulatory gives Regulatory Affairs and Clinical Operations teams AI across the submission and enrollment lifecycle — so the gaps get found before the agency does.
Sutra Regulatory is not a document repository with search.
It does not just store your submission and help you locate documents faster. It reads across the entire CTD package, maps it against current FDA and ICH guidance, identifies what is missing or inconsistent, and scores readiness before you file. On the clinical side, it matches eligible patients at a scale no manual chart review can reach and forecasts enrollment risk before delays have already compounded.
What Regulatory Affairs and Clinical Operations teams are dealing with right now.
- ●Submission packages with inconsistencies that only surface after filing — when the cost is already a CRL and an 18-month delay.
- ●Regulatory guidance updates creating alignment gaps that get discovered too late to address before submission.
- ●Clinical enrollment delays that compound for months before anyone has quantified the risk or triggered a course correction.
- ●Site performance issues that stay invisible until trial timelines have already slipped past recovery.
- ●No structured readiness score before a submission goes out — confidence based on experience, not evidence.
Find the gaps before the agency does.
A structured readiness score across every CTD module — flagging high-risk areas with missing evidence, guidance misalignment, or cross-module inconsistencies. With enough time to actually address them before you file.
Scans the full submission package for inconsistencies in data, terminology, and claims across every CTD module before submission.
Maps submission content against current FDA and ICH guidance, flagging gaps and misalignment before filing.
Identifies where required data, studies, or documentation appears absent or insufficient relative to regulatory expectations.
A Complete Response Letter delays a program by 12 to 18 months on average and represents tens of millions in delayed revenue, additional studies, and extended development costs. Most submission gaps are findable before you file.
Find eligible patients faster. See enrollment risk before it compounds.
Predicts enrollment timeline and site performance risk — giving Clinical Operations teams early warning before delays compound.
Matches patient profiles against trial eligibility criteria using structured and unstructured EHR data — identifying qualified candidates at a scale manual chart review cannot reach.
Identifies biomarker-defined patient subpopulations relevant to the trial, drawing from literature and registry data.
Tracks site-level enrollment performance and flags underperforming sites before they impact the overall trial timeline.
Recruitment challenges account for 37% of clinical trial delays.
— Tufts Center for the Study of Drug Development (CSDD), 2024
From data ingestion to a living audit trail.
- 01Submission and trial data come in
CTD modules, regulatory guidance, EHR data, and site performance feed into the platform.
- 02The system scans for gaps
Cross-module inconsistencies, guidance misalignment, missing evidence, and eligibility matches are identified across the full submission and enrollment scope.
- 03Readiness is scored
A structured readiness assessment is generated across submission modules and enrollment forecasts — showing where the risk is and how much time you have to act.
- 04The audit trail stays current
Every guidance reference, consistency check, and decision is logged continuously — a regulatory audit trail that stays ready for review.
Designed for the teams doing the work.
Frequently asked.
What does Submission Readiness Scoring assess?+
It produces a structured score across every CTD module — flagging high-risk areas with missing evidence, guidance misalignment, or cross-module inconsistencies before the submission goes out.
How does AI Eligibility Matching work?+
The system reads patient data from connected health record systems and matches profiles against your trial's eligibility criteria automatically — identifying qualified candidates at a scale manual chart review cannot reach.
What is the cost of a Complete Response Letter?+
A CRL delays a program by 12 to 18 months on average and represents tens of millions in delayed revenue, additional studies, and extended development costs.
Can Sutra Regulatory support both submission and enrollment workflows?+
Yes. Sutra Regulatory covers the full regulatory lifecycle — from pre-submission consistency checking through clinical enrollment intelligence and site performance monitoring.