Precision Disclosure.
Zero Friction.
Our clinical trial disclosure services provide expert ClinicalTrials.gov compliance and results disclosure for sponsors who value accuracy and speed.
Study Registration
- Protocol Mapping: Extraction of required PRS fields directly from your protocol.
- Strategic Summaries: Writing QC-ready, non-promotional narratives that pass on the first attempt.
- Outcome translation: Mapping study endpoints to use the language of ClinicalTrials.gov.
Results Disclosure
- Data Translation: Converting CSR data into PRS formats.
- Outcome Metrics: Defining primary and secondary endpoints with statistical precision.
- Adverse Event Reporting: Accurate entry of Serious and Anticipated Adverse Events.
PRS Review Feedback Resolution
Stuck with “Major Comments” or a “Problem” alert?
We provide rapid intervention to decode reviewer feedback, perform top-to-bottom consistency audits, and handle the formal re-submission process to secure immediate approval.
Strategic Portfolio Oversight
Proactive monitoring of your entire study account. We can track the 12-month post-PCD deadlines to eliminate the risk of FDA 483s and significant civil money penalties.