Blogs
Explore the latest insights & trends in clinical research: Our blog is your go-to source for innovative perspectives & expertise
Latest Blogs
Clinical Research Technicians: Their Role and Responsibilities During Clinical Trials
Welcome to the exciting world of Clinical Research Technicians (CRTs) and their critical role in clinical trials. In the realm of pharmaceutical drug development, these professionals are indispensable, ensuring the smooth conduct of clinical trials from inception to...
Understanding the Roles of Operations and Quality in a CRO
In Clinical Research, as in most things in life, balance is key. An even balance between clinical operations and clinical quality assurance is essential to the success of any clinical trial, not just during the clinical conduct, but in all areas from proposal to...
SPOTLIGHT ON: Dr. Janice Faulknor – Medical Director and Principal Investigator
Ever since she was a child, Dr. Janice Faulknor knew that she wanted to help people. One of her greatest passions, running, led her to meet a group of accomplished women, one of which inspired her to pursue her dream of becoming a medical doctor. Dr. Faulknor's...
The Role of Lead Clinical Data Manager in Phase 1 Clinical Trials
In the fast-paced world of drug development, the role of a Lead Clinical Data Manager in clinical studies, especially Phase 1 clinical trials, is indispensable. They play a vital role in ensuring the success of Phase 1 clinical trials by overseeing clinical data...
The Summer Internship Experience at BioPharma Services as a Clinical Research Assistant
To introduce myself, my name is Sean Hayden John, and currently I am going into my second year of Queen’s Health Sciences through the Queen’s Accelerated Route to Medical School (QuARMS) pathway. During my first year of university, thanks to both my program’s core...
BioPharma Services Highlights from the DIA Annual Meeting, 2023
The DIA 2023 Annual Meeting in Boston gathered experts, professionals, and regulators from around the world to discuss and highlight valuable insights into the latest developments in drug development, regulatory affairs, and clinical research. BioPharma Services Inc....
The Summer Internship Experience at BioPharma Services Bioanalytical Lab
Hey there, my name is Ronin, and this summer I have been fortunate enough to start a position as an assistant in BioPharma Services Research and Development bioanalytical lab. As a Bachelor of Health Sciences student at Queen’s University, gaining practical experience...
The Role of Controlled Clinical Trials in Drug Development
During the process of clinical drug development, it is critical to discriminate between patient outcomes caused by treatment with a New Chemical Entity (NCE) or a new Investigational Medicinal Product (IMP) and outcomes that occur as a result of other factors,...
Ensuring Clinical Trial Confidence Through Computer Systems Validation
Computer Systems Validation (CSV) is a process that ensures computer systems, including software and hardware, used in regulated industries such as pharmaceuticals, medical devices, and finance are fit for purpose and meet regulatory requirements. CSV's goal is to...
Advancing RNA-Targeted Therapies: A Phase 1 Clinical Perspective on Oligos and Beyond
In recent years, RNA-targeted therapies have emerged as a promising frontier in the world of medicine. By harnessing the power of RNA, these innovative treatments have the potential to revolutionize how we treat a wide array of genetic diseases. As a leading Phase 1...
Understanding Good Documentation Practice (GDP) and its Role in Good Laboratory Practice (GLP)
Good Documentation Practice (GDP) is a set of guidelines and procedures established to create, review, approve, distribute and maintain documentation within regulated industries such as pharmaceuticals, healthcare and manufacturing. The guidelines for GDP were created...
PBPK Modeling in Predicting Drug Behavior
Physiologically-based pharmacokinetic (PBPK) is a mathematical modeling approach used in pharmacology and toxicology to predict the behavior of drugs in the body. PBPK models take into account the physiological and biochemical characteristics of the body, such as...
Navigating ANVISA’s Requirements: A Guide to Performing and Analyzing Bioequivalence Studies for the Brazilian Health Authority
In the realm of pharmaceutical research and development, ensuring the safety and efficacy of drugs is of paramount importance. Bioequivalence (BE) studies play a crucial role in this process for generic drug development, and regulatory bodies like the Brazilian Health...
What Is an ADME Study?
The pharmacokinetic properties of a new chemical entity (NCE) or an investigational medicinal product (IMP) must be elucidated during clinical drug development. This includes the analysis of their absorption, distribution, metabolism, and excretion (ADME) and is...
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