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Clinical research is evolving rapidly. While randomised controlled trials (RCTs) remain the gold standard for establishing the safety and efficacy of new therapies, there is increasing recognition that understanding how treatments perform in real-world clinical settings is equally important. This shift has accelerated the use of real-world evidence (RWE) in drug development. Regulatory bodies, including […]

When the U.S. Food and Drug Administration first introduced Project Optimus, it marked a decisive shift in how oncology drugs are developed. Several years on, its impact is no longer theoretical; it is actively reshaping dose optimisation and trial design. For sponsors and CROs alike, understanding how to operationalise this initiative is now critical. What […]

Selecting a Contract Research Organisation (CRO) is one of the most consequential decisions a sponsor will make during clinical development. Whether you are a biotech entering First-in-Human studies or a pharmaceutical company progressing into Phase III, the right CRO can improve operational control and reduce development risk. Understanding how to choose a CRO requires more […]

Eye cancer, also known as ocular cancer, refers to a group of rare but potentially serious malignancies that develop within the eye or its surrounding structures. While uncommon, eye cancer presents unique clinical challenges due to its impact on vision, complex anatomy and potential for metastasis. For healthcare professionals, sponsors and clinical research organisations (CROs), […]

Cancer remains one of the most complex and challenging areas of modern medicine, driving continuous innovation in drug development. At the heart of this progress are oncology clinical trials, which play a critical role in advancing new therapies and improving patient outcomes. For biotech and pharmaceutical companies, these trials are not only a regulatory requirement […]

Phase 1 trials are the first clinical trials to include humans. They are essential in determining the safety and tolerability of a drug in development. A well-designed phase 1 clinical trial is heavily dependent on clinical pharmacology, the medical discipline that bridges preclinical science into data-driven decisions. Without thorough clinical pharmacology, Phase 1 clinical trials […]