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The development of bioanalytical methods and subsequent quantification of analytes in a range of biological matrices is fundamental to the drug discovery and development process. Having a reliable and robust methodology, for all target species, including human, plays a key role in understanding how investigational drugs are metabolised following administration.  By accurately evaluating both the […]

You are coming close to having completed your nonclinical studies and you are beginning to think about your next steps.  But exactly what are those?  Chances are you are moving into unknown territory with your asset, and you may even have a crucial milestone to consider.  How do you navigate your way through the regulatory […]

The world of medical research and development is constantly advancing, and clinical trials play a crucial role in bringing new treatments and cures to patients. However, conducting a successful clinical trial is a complex and expensive undertaking with the average cost of bringing a drug to market being around $2.3B. Clinical trials require precise planning, […]

Being first to market with an innovator drug remains the ultimate goal for all, and most organisations are constantly reviewing timelines in order to achieve efficiencies through trial design, conduct and the reduction of downtime between phases of drug development. But clinical trials and drug development is an expensive and slow process, representing approximately 60% […]

One of the key challenges facing researchers working on treatments for rare diseases is recruitment for clinical trials. Because these diseases are relatively uncommon, it can be difficult to find enough patients to participate in studies and help advance treatment options. Additionally, there is often a lack of awareness for the condition, making it difficult […]

In recent decades, clinical trials and their methodologies have evolved significantly. New technologies have led to improved research methods, techniques and strategies in clinical trial management and in site management and monitoring specifically. Additionally, new regulations and other external factors have resulted in changes to clinical trial approaches. For instance, social distancing restrictions during the […]

Pharmaceutical companies all over the world outsource some or all elements of their clinical trials in order to better manage resources, improve efficiency and save their clinical development budget. However, with those budgets being squeezed ever tighter, whilst clinical outsourcing has many advantages, there are potential pitfalls if you choose the wrong Contract Research Organisation […]