Description The CRA should ensure adherence to International Conference On Harmonization- Good Clinical Practice (ICH-GCP), Sponsor & Phoenix CR SOPs, Study Protocols and all applicable regulatory requirements. Location: Iraq Principal Duties and Responsibilities: • Schedules, plans, and performs site visits according to the monitoring plan and SOPs to ensure...
Description The CRA should ensure adherence to International Conference On Harmonization- Good Clinical Practice (ICH-GCP), Sponsor & Phoenix CR SOPs, Study Protocols and all applicable regulatory requirements. Location: UAE Principal Duties and Responsibilities: • Schedules, plans, and performs site visits according to the monitoring plan and SOPs to ensure...
Description The Research Nurse (RN) ensures that the clinical trials are carried out according to the protocol, local regulations and the followed guidelines, such as Good Clinical Practice (GCP), Good Documentation Practice (GDP), etc. The RN must be trained on the applicable SOPs, study requirements, supporting documents,...
The US FDA has announced approving Xenpozyme (Olipudase alfa), for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD). The medication is the first to treat symptoms that are not related to the central nervous system in patients with ASMD. ASMD is...
The Department of Health – Abu Dhabi (DoH) has announced launching a Real-World Evidence Study to offer critical real-world data on the safety and effectiveness of AstraZeneca’s long-acting antibody combination, Evusheld. Evusheld was launched last March in UAE to protect immunocompromised patients against COVID-19. It...
UK government has recently announced that starting next fall, people over 50 would be able to receive an enhanced version of Moderna's COVID-19 vaccination that includes protection against Omicron, after British drug regulators (MHRA) became the first in the world to approve it. The booster shot...