Clinical Research Clinical Trials Containment Licensing 
Pfizer
FEBRUARY 16, 2023
These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.
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. associates, residents, research fellows).
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XTalks
APRIL 24, 2023
Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.
Drug Discovery World
AUGUST 3, 2023
Even still, these approved drug products require a licensed healthcare provider’s prescription. With this in mind, the FDA claims to be committed to sound scientific research into the area and has a number of processes in place for those in the medical research community who intend to study cannabis 1.
The Pharma Data
NOVEMBER 22, 2020
Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent. About IMPOWER Clinical Trials Program.
The Pharma Data
DECEMBER 14, 2020
Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. About Transcend Biodynamics. Source link.
The Pharma Data
NOVEMBER 5, 2020
About the Trial The RECOVERY trial is conducted by the registered clinical trials units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.
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