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...
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All Blogs – Clinical Research
Foreign Trained Professionals; the Unsung Heroes of the CRO Industry
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 living in Canada - roughly 20...
Eight Reasons to Choose Canada for Your Phase 1 Clinical Trial
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...
Leveraging the 505(b)(2) Program to Prolong the Life of a New Chemical Entity (NCE)
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...
Importance of Study Restriction: The Avoidance of Drug-Drug Interactions Part 1
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,...
NDA Enabled Phase 1 Clinical Trials: Unveiling the First Step
The journey of a new drug from concept to market is a complex and highly regulated process. At its core lies the New Drug Application (NDA) submission – a critical milestone that paves the way for new medications to reach patients in need. But how do drugs reach this...