Your resource for Multisite Studies
When medical circumstances are severe and treatment options are limited in number or effectiveness, being able to help patients improve their quality of life (QOL) takes on an elevated importance. To effect changes in QOL, clinical studies should address outcomes that are meaningful to patients, especially for “insidious” diseases that slowly wear them down. This […]
The post Quality-of-life Improvements for Heart Health in Scarce Treatment Settings appeared first on Journal for Clinical Studies.
Historically gaining regulatory approval across multiple countries within the European Union (EU) was segmented, excessively bureaucratic, and challenging to navigate. Sponsors had to submit clinical trial applications separately to national competent authorities (NCA) and ethics committees (ECs) in each country to gain regulatory approval to run a clinical trial. Individual countries dictated their own set […]
The post A Reflection on the European Regulatory Framework appeared first on Journal for Clinical Studies.
The feasibility of clinical trial involves a thorough assessment of the potential and practicality of conducting a particular trial within a specified geographic area to ensure a project’s success in terms of timeline, target achievement, cost management, and various other essential factors. The extent of feasibility outreach can constitute an initial assessment phase that provides […]
The post Feasibility Assessments: What Investigators Need to Know appeared first on Journal for Clinical Studies.
The trial master file is integral to demonstrating that a clinical trial has been conducted in accordance with good clinical practice (GCP). The sponsor must therefore ensure their TMF is complete, timely, and accurate at all stages of a trial and across the document lifecycle. Managing the TMF, however, has often been a challenge for […]
The post Five Trends Shaping the Trial Master File appeared first on Journal for Clinical Studies.
As regulatory Agencies around the world continue to refine and update their requirements, artificial intelligence (AI) can help Life Sciences companies increase their chances of new products being accepted promptly. ArisGlobal’s Agnes Cwienczek & Renato Rjavec describe how AI, and Generative AI in particular, are distilling insights from regulatory exchanges and harnessing the latest global […]
The post Generative AI Drives Efficient Regulatory Processes appeared first on Journal for Clinical Studies.
Global Cannabis market size was valued at USD 14154.75 million in 2023 and is expected to expand at a CAGR of 17.17% during the forecast period, reaching USD 36619.44 million by 2031.1 While Kratom on the other hand valued at USD 1.87 Billion in 2023 and is expected to grow at a CAGR of 17.2 […]
The post Green Miracles: Cannabis and Kratom’s Potential for Healing and The Industry in Malaysia appeared first on Journal for Clinical Studies.
Quantitative systems pharmacology (QSP) and physiologically based pharmacokinetic (PBPK) modelling can be employed to create a parallel virtual workflow throughout drug development, beginning with preclinical research and continuing through phase IV clinical studies. Many clinical trials are conducted with virtual patients prior to selecting some trials to be carried out with real patients in real […]
The post Conducting Clinical Trials in the Parallel Virtual Universe appeared first on Journal for Clinical Studies.
Obesity is commonly defined as excess fat accumulation that puts someone at a higher risk for adverse health outcomes.1 The simplicity of this definition can be misleading, because obesity’s pathophysiology is highly complex, and characterised by a multitude of interrelated factors, including metabolic and immune changes in response to energy surfeit; mechanisms such as oxidative […]
The post Advancing Research and Development of Multi-indication and Combination Therapies for Obesity appeared first on Journal for Clinical Studies.
Rare diseases are often chronic conditions that begin to manifest during childhood.1 The effects of disease change everything from direct consequences of having the condition to impact on the child’s growth patterns and development, behaviour, psychology, self-worth, and self-belief. All these alongside the untold impact on the families who support them. At the current time, […]
The post Defining Success in Rare Disease Paediatric Trials appeared first on Journal for Clinical Studies.
The first chemotherapy drugs were discovered by mistake – during World War II – when humans were accidentally exposed to mustard gas. At that time, the only other treatments for cancer were radiotherapy and surgery. But these weren’t necessarily promising for the treatment of all forms of cancer, especially cancers that had progressed. Scientists were […]
The post Cell and Gene Therapies are set to Revolutionise Healthcare: Here’s How appeared first on Journal for Clinical Studies.
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