Blogs
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Latest Blogs
It Takes a Village: An Interview with Dr. Ola Kassim
No stranger to adversity, Olayiwola (Ola) Kassim was born and raised in Lagos, Nigeria. From an early age he saw doctors as heroes, as personified by his uncle who studied nursing abroad in the UK and his sister who later did the same. He lost his mother at only 3...
Exploring Clinical Trial Protocol Deviation: A Comprehensive Guide
Clinical study protocols are conducted according to the International Council for Harmonization guidance on Good Clinical Practice (GCP) which outlines safeguards for the rights, safety and well-being of participants. Protocols “should [also] be designed, conducted...
Crafting Workplace Symphony at a CRO
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...
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...
Why Every Phase 1 Clinical Study Needs a “Protocol Champion”
The clinical drug development process is challenging and time-consuming and requires the collaborative efforts of a multidisciplinary team of experts over a prolonged period of time. Accordingly, one of the challenges associated with clinical studies, including Phase...
Internal Standard Responses in LC-MS/MS Based Bioanalysis: Friend or Foe?
The use of LC-MS/MS in regulated bioanalysis is common-place due to its high sensitivity, selectivity, quantitative accuracy, and reliability. Internal standards play a key role in quantitative bioanalysis, compensating for variability in the analyte response. In...
A Simulation-based Decision Guide to Evaluate Missing Data in Clinical Studies
Comparative bioavailability (BA) or bioequivalence (BE) studies might be one of the most common clinical trials for both new drug innovators and the generic manufactures. Like other studies with PK endpoints, selecting an adequate and robust sampling time is essential...
A Simulation-based Decision Guide to Navigate Missing Data in Clinical Studies
Missing Data – A Common But Critical Issue in Clinical Studies In part one, of this two part blog series, we will discuss the missing data issue in clinical studies. In bioavailability (BA) and bioequivalence (BE) studies with pharmacokinetic endpoints, the occurrence...
Clinical Research Coordinator (CRC) Journeys at BioPharma Services
This blog unfolds the varied journeys of three individuals at BioPharma Services, each narrating their unique experience in the clinical research landscape. From the initial steps as interns to evolving into Clinical Research Coordinators, their stories reflect the...
Crossing Clinical Frontiers: My Transition from CAMH to Phase 1 Studies Manager
In a world where our beginnings often predetermine our paths, my story is a testament to the power of perseverance, adaptability, and an unyielding commitment to excellence. Born into the confines of traditional Chinese customs, my journey has been about challenging...
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