Clinical Development Clinical Trials Containment 
Worldwide Clinical Trials
FEBRUARY 21, 2024
During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity.
Pharmaceutical Technology
FEBRUARY 8, 2023
On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.
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XTalks
NOVEMBER 6, 2020
Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.
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.
FDA Law Blog
MARCH 7, 2024
Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.
Worldwide Clinical Trials
JUNE 15, 2022
It really is—there has been a 10x increase in cell and gene therapies in the clinical development pipeline since 2012. Most of this pipeline focuses on oncology and rare disease investigational therapeutics, and most, unsurprisingly, are in the earlier phases of development. The cell and gene therapy pipeline is booming.
Advarra
OCTOBER 4, 2023
When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.
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