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Explore the latest insights & trends in clinical research: Our blog is your go-to source for innovative perspectives & expertise
Latest Blogs
Risk Management in Clinical Trials: The Sub-Investigators Role in Protecting Sponsor Investments
Clinical trials are a cornerstone of pharmaceutical development, entailing significant investment in terms of time, money, and resources. These early stage clinical trials are fraught with various risks ranging from clinical failures to regulatory issues, all of which...
Understanding Flip-Flop Pharmacokinetics: Challenges and Strategies in Drug Development
Pharmacokinetics (PK) modeling has been a useful tool thorough from pre-clinic to clinical (from Phase 1 to 3) in drug development, clinical research, and therapeutic optimization for centuries. The PK model used quantitative parameters to describe the complex...
Embracing Global Diversity: Celebrating Cultural Heritage in the Workplace
BioPharma Services Inc. is a place where diversity truly thrives. It isn’t just a buzzword—it’s the heartbeat of our organization. With team members hailing from all corners of the globe, our workplace is a vibrant mosaic of cultures, languages, and traditions....
The Role of IND-enabling Studies
IND-enabling studies are crucial for advancing a New Chemical Entity (NCE) from preclinical evaluation to its first-in-human clinical trial. These studies comprehensively assess the NCE's safety, pharmacology, and manufacturing processes, leading to the submission of...
The Essentials and Importance of Phase 1 Clinical Trial Design
Clinical drug development progresses with the conduct of clinical trials, with different phases of clinical trials focusing on different aspects of the development process. Phase 1 clinical trials, including first-in-human studies, evaluate the safety and dose range...
Preventing Hypoglycemia in Clinical Trials: Rethinking the Role of Glucose Solutions for Adverse Event Prevention
Although strictly controlled, the introduction of therapeutic medications to normal healthy subjects can entail certain risks to the participants. For example, hypoglycemia is notably an anticipated adverse outcome in BA/BE and Phase 1 clinical trials involving...
Statistical Methods – The Conventional Approach vs. The Simulation-based Approach
Abstract. In this blog, we provide a comparison between simulation-based and conventional statistical methods, examining their respective principles, applications, strengths, and weaknesses. We provide a simple real-life example to illustrate similarities and...
Pharmacokinetic Modelling: Choosing the Right PK Model in Drug Development
Choosing the right pharmacokinetic (PK) model is like finding the perfect recipe for a gourmet meal; it requires precision, expertise, and a deep understanding of the ingredients involved. In the world of drug development, PK models are the secret sauce that can make...
HIGHLIGHTS FROM THE DIA ANNUAL MEETING, 2024 from BioPharma Services
At the 2024 DIA Annual Meeting in San Diego, the pharmaceutical and healthcare industries converged on several pivotal reflecting ongoing transformations within the sector. Here are some key themes that dominated discussions: AI in Drug Development: Discussions...
How Important is Biostatistics?
In the journey of drug development, biostatistics emerges as a cornerstone, ensuring that the path from the laboratory bench to the patient's bedside is navigated with precision, efficiency, and scientific rigor. For Phase 1 Clinical Research Organizations (CROs) like...
A Simulation Based Decision Guide To Evaluate Missing Data In Bioavailability And Bioequivalence Studies
Refer to Part 1 and Part 2 of this topic series. This blog is based off a poster presentation presented at the ASCPT 2024 annual meeting. To download a PDF version, click here. Clinical studies are, albeit well-controlled, not immune to missing data, and it is crucial...
Excellence in Clinical Trial Project Management
At BioPharma Services Inc, our story isn't just about groundbreaking medical research; it's a tale of passionate individuals driven by a shared vision to make a real difference in patient lives. Founded by surgeons and led by a team of experts, BioPharma Services is...
Exploring the Pros and Cons of AI in Medical Writing
The Rise of AI in Medical Writing for Clinical Trials Undoubtedly Artificial Intelligence (AI) and ChatGPT have been the hot topics of conversation for the past year. These technologies have become personal assistants in many aspects of our lives, helping to solve a...
Bioanalytical Method Development: Blood Specimen
The development of new drugs is a long, complex, expensive, and multidisciplinary process. Drug discovery and development takes more than 10 years, and the average cost of each new drug approved for clinical use is more than $1 billion. In addition, 90% of drug...
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