Extract to table
Pull the structured facts out of a document: parties, dates, amounts, obligations.
Extract to table / pre-sub-package-clinical-protocol-summary.docx
pre-sub-package-clinical-protocol-summary.docx
Parties
Harkness LLP
Solstice Biomedical Inc
Solstice Biomedical Devices Ltd
Meridian Conformity Assessment GmbH
Pinnacle Regulatory Consulting Group LLC
Adriatic Partners LLC
Key Inc
Veltrano Clinical Research Organization Inc
Dates
June 16, 2025
September 12, 2024
March 8, 2023
June 18, 2022
March 7, 2024
January 15, 2025
August 14, 2025
September 15, 2025
March 15, 2026
Amounts
$4,200,000
$12,000
Obligations
The pre-specified success criterion for the primary endpoint is that the upper bound of the 95% confidence interval (CI) for the overall MARD must be ≤ 9
Subjects must meet all of the following criteria to be eligible for enrollment: 1
Female subjects of childbearing potential must have a negative urine pregnancy test at screening
All subjects must sign the IRB-approved informed consent form prior to any study-related procedures