Category: Blog

  • Clinical Trials Day: Celebrating the Impact of Research on Medical Progress

    Clinical Trials Day: Celebrating the Impact of Research on Medical Progress

    Clinical trials have been a cornerstone of the medical field for decades, serving as a critical foundation for the development and advancement of treatments across a wide range of diseases and health conditions. Beyond establishing the safety and effectiveness of new treatments, clinical trials also play a vital role in exploring ways to enhance care,…

  • How Clinical Trials Can Help Sarcoidosis

    How Clinical Trials Can Help Sarcoidosis

    Clinical trials are essential for advancing treatments for sarcoidosis, especially since no cure currently exists. With the cause of sarcoidosis still unknown, ongoing research remains critical to understanding and combating the disease. Simbec-Orion is a Clinical Research Organisation specialising in rare diseases and oncology, with almost five decades of experience in delivering clinical trial management…

  • The Role Of Clinical Trials In Testicular Cancer 

    The Role Of Clinical Trials In Testicular Cancer 

    Clinical trials play a key role in advancing the understanding and treatment of testicular cancer. As one of the most treatable forms of cancer, testicular cancer has a high survival rate when detected early. They offer new explorations into medicines, therapies, and treatment combinations that may improve a patient’s outcome at all stages of the…

  • The Role of Clinical Trials in Parkinson’s Disease

    The Role of Clinical Trials in Parkinson’s Disease

    Clinical trials play a crucial role in advancing treatments for Parkinson’s disease, especially as there is still no cure and much about the disease remains unknown. As the fastest-growing neurological condition worldwide, Parkinson’s will impact approximately 1 in 37 people in the UK over their lifetime, making continued research essential. With nearly five decades of…

  • FAQ: Key Project Optimus questions for oncology drug developers

    FAQ: Key Project Optimus questions for oncology drug developers

    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…

  • Improving Diversity and Inclusion in Clinical Trials

    Improving Diversity and Inclusion in Clinical Trials

    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…

  • Navigating Project Optimus: The role of CROs

    Navigating Project Optimus: The role of CROs

    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…

  • FDA Draft Guidance on Protocol Deviations in Clinical Investigations – Key Takeaways

    FDA Draft Guidance on Protocol Deviations in Clinical Investigations – Key Takeaways

    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…

  • Project Optimus: Shifting the paradigm in oncology drug development

    Project Optimus: Shifting the paradigm in oncology drug development

    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…

  • How Medical Research is Advancing Treatments for Rare Diseases

    How Medical Research is Advancing Treatments for Rare Diseases

    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…