Unveiling the Canvas: A Maestro's Tale In the heart of BioPharma Services' flourishing ecosystem stands the People and Culture Champion. Functioning as the architect of engagement, a mediator in reducing turnover, and a meticulous curator of our organizational...
All
All Blogs – Clinical Research
ANDA or 505(b)(2): Choosing the Right Approval Pathway for Your Drug
505(b)(2) pathway approvals have experienced double-digit growth recently. Many drug companies are electing to pursue 505(b)(2) applications to obtain a new drug approval (NDA). For developers seeking to obtain approval for previously approved drug products in the...
The Role of AI in Clinical Trials
Artificial intelligence (AI) - based technologies are increasingly finding applications in multiple industries, including the pharmaceutical field. AI integration into drug development contributes to the enhancement of testing accuracy and efficiency, expedites the...
Bioanalytical Lab: The Benefits of High Quality
The bioanalytical laboratory of BioPharma Services Inc. (BPSI) has a proven track record for scientific excellence, perseverance, and an unwavering commitment to provide services of the highest quality. This has allowed establishment of efficient laboratory workflows...
Change Management of Computerized Systems and Common Challenges
forChange is the only constant, and clinical research organizations (CROs) have evolving needs and technology, which brings change regularly. As a Phase 1 clinical trial CRO, and a heavily regulated industry, strict protocols, and compliance requirements govern every...
Advancing Regulatory Framework for Predicting the Proarrhythmic Risk
The issue of QT prolongation has garnered significant attention from regulatory bodies such as Health Canada, the Food and Drug Administration (FDA), and the European Medical Agency (EMA). Back to the 1950s, doctors observed an alarming phenomenon among some heart...