Category: Blog

In 2021, Project Optimus was launched by the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) to help oncology drug developers target dose optimisation and guide selection processes. Here, we answer some of the most pressing questions developers may have about the initiative. 1. What is the aim of Project Optimus? The…

Promoting greater inclusivity among clinical trial participants plays a pivotal role in addressing healthcare inequalities and fostering equal access to healthcare. To further our understanding of treatments and vaccines, it’s crucial that those taking part in trials mirror the disease’s prevalence in various demographics and accurately represent relevant clinical populations.  Increasing clinical trial diversity and…

Project Optimus, an initiative introduced by the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) in 2021, has an overarching goal of shifting the paradigm of dose selection in oncology drug development [1]. It aims to move away from the traditional focus on the maximum tolerated dose (MTD) to selecting doses that…

Romillie Cruz MD, Vice President Medical & Scientific Services, Simbec-Orion The FDA has released a draft guidance last December 2024 on protocol deviations in clinical investigations of drugs, biological products, and medical devices. This document provides essential recommendations for sponsors, investigators, and IRBs to help ensure compliance, data integrity, and patient safety. Key Highlights: What This Means for Simbec-Orion:At Simbec-Orion, we…

In recent years, the U.S. Food and Drug Administration (FDA) has frequently required sponsors to conduct post-marketing trials after approval. These studies or trials have often been completed to obtain additional information on the optimum dosage of a product where the maximum tolerated dose (MTD) had been used for pivotal trials, in addition to providing…

The pursuit of effective treatments for rare diseases is an important undertaking for medical researchers around the world. Rare diseases inherently affect a small amount of the population, which often makes traditional drug development economically unviable. However, addressing the challenges faced by those living with these conditions remains crucial. Clinical trials play an important role…

In the fast-paced world of clinical research, effective medical writing plays a crucial role in taking a drug to market. And with clinical advancements occurring at an increasingly competitive rate, the demand for well-crafted and time-efficient clinical documentation is greater than ever. However, allocating time and resources to clinical writing poses a significant challenge.  This…

Since the COVID-19 pandemic, remote monitoring in clinical trials has become increasingly popular. During the pandemic, on-site trial participation became disrupted, making it very difficult, if not impossible, to conduct on-site clinical monitoring. This forced the clinical research industry to explore the possibilities of remote monitoring. Remote monitoring allows the investigator to collect and review…

One of the greatest challenges facing clinical trials is recruitment. It can be extremely difficult to recruit enough participants to take part in a clinical trial. In fact, it is so difficult that the majority of clinical trials fall short of the number of people they need, with some trials even struggling to recruit a…

The field of clinical research is the bedrock upon which modern medicine builds its advancements. The importance of addressing challenges and seizing opportunities in this domain cannot be overstated. As the healthcare and life sciences industry continues to evolve, an understanding of the impact of effective clinical research is vital to medical innovations and patient…