Advarra
APRIL 30, 2024
Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Below are examples of key items auditors/inspectors look for during an audit.
The Pharma Data
NOVEMBER 5, 2020
Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.
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Advarra
SEPTEMBER 7, 2023
This includes the IRB or EC, sponsored research, and the clinical trials office – when a COI is identified, HRPP staff can collaborate to determine appropriate management. Typically, this is the office of sponsored programs or a clinical trials office. HRPPs vary widely in structure, size, and component programs and offices.
The Pharma Data
DECEMBER 29, 2020
As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).
The Pharma Data
DECEMBER 31, 2020
Right now, most shots are being given at hospitals, clinics and nursing homes, but Perna and Slaoui agreed that the pace of vaccination should pick up considerably once doses are given out by the major pharmacy chains. Another COVID-19 vaccine enters final trials. A global scourge. By Thursday, the U.S.
The Pharma Data
NOVEMBER 18, 2020
“Tampa General Hospital and USF Health were already actively conducting clinical trials on COVID-19 and had the team, location and infrastructure in place to identify and care for the patients who can benefit most from this treatment.”
The Pharma Data
JANUARY 13, 2021
Right now, the vaccines are largely being distributed to people in the highest-risk categories, including frontline health care workers and older people and staff in nursing homes. More community centers and pharmacies will also be added to the list of places where people can be vaccinated, the Times reported.
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