In the dynamic world of clinical trials, the adoption of Standard Operating Procedures (SOPs) and a robust Quality Management System (QMS) or Electronic Quality Management System (eQMS) is pivotal. Let's explore the intrinsic importance of clinical trial SOPs and...
At Biopharma Services, we execute every step of a Phase 1 study from protocol development to regulatory submissions to recruitment to data management and statistical analysis to the final study report. But what if a Phase 2 or late phase study only requires backend...
Currently, annual immigration in Canada amounts to almost 500,000 new immigrants – one of the highest rates per population of any country in the world. As of 2023, there were more than eight million immigrants with permanent residence status living in Canada – roughly...
For many study sponsors, the end goal of their clinical drug development program is to enter the United States drug market. However, conducting your Phase 1 clinical trial in Canada is an alternative route that can fast-track the CTA process and get the approval for...
This is an continuation of When is 505b2 a good choice for your new drug application? In the world of pharmaceuticals and drug development, the journey from discovery to market can be a long and arduous one. Even after years of research, extensive clinical trials, and...
Drug interaction management is a significant concern in designing clinical trials, especially those focusing on pharmacokinetic (PK) endpoints. Such interactions, both expected or unexpected drug-drug interactions, may arise from the prescribed treatment regimen,...
