The ClinicalTrials.gov Compliance Specialists
Expert PRS registration and results disclosure for pharma and biotech sponsors. First-attempt QC approval, every time.
The cost of getting this wrong is not theoretical
The FDA now issues civil money penalties of over $13,000 per day for missed disclosure deadlines — and automated tracking means overdue records are flagged without a courtesy warning. The Protocol Registration and Results System (PRS) has zero tolerance for floating verbs, unanchored timeframes, or off-by-one rounding in your safety tables.
We exist so your clinical team doesn’t have to become PRS experts. We handle registration, results disclosure, and reviewer feedback resolution — so you stay focused on the science.
What We Do
Consulting Services
We provide expert consulting to help small and medium-sized pharmaceutical companies successfully register clinical studies and disclose results on ClinicalTrials.gov.
ClinicalTrials.gov: The Guide
We provide a straightforward, step-by-step guide that empowers clients to easily register studies and disclose results on their own.
Specialized Clinical Trial Disclosure Solutions
From initial study registration to complex results mapping, we handle the technical precision required for PRS compliance.
Combining a deep understanding of Good Clinical Practice (GCP) with rigorous scientific editing standards, our clinical trial disclosure services ensure every submission is meticulously crafted to pass NIH Quality Control (QC) on the first attempt.
Full-Service Clinical Trial Registry Compliance
End-to-end compliance for sponsors who can’t afford delays
From drafting QC-ready Brief Summaries to building compliant Adverse Event tables, we manage the entire disclosure lifecycle. One point of contact. No rejected submissions. No missed deadlines.
PRS Major Comment Resolution
Stuck with a Problem alert or Major Comments?
We decode reviewer feedback, perform a full consistency audit across your study modules, and execute the precise edits needed to restore your records to compliance — fast.
Regulatory Toolkits
Empower your in-house team
Our on-demand toolkits give your regulatory staff a Safe Language Library of pre-approved outcome phrasing, submission checklists, and step-by-step guides for every PRS module. Reduce internal QC rejection rates without adding headcount.
Why Clinical Disclosure?
- Over a decade of dedicated ClinicalTrials.gov PRS experience
- First-attempt NIH QC approval — not close-enough submissions that come back with Major Comments
- Deep familiarity with FDAAA 801, 42 CFR Part 11, ICH E6(R3), and EU CTR requirements
- We write to the standard of rigorous scientific editing — not regulatory boilerplate