When it’s done right, market research enables you to make more informed business decisions. ISR Reports is a full-service pharmaceutical market research company operating exclusively in the life sciences space. For data on CRO quality benchmarking/performance reviews, clinical technology, CRO market size projections, clinical development outsourcing models, Phase 1 through late-phase study trends and market outlooks, and more, click here.
NeuBase is attempting to create a treatment for two rare diseases: Huntington’s disease and myotonic dystrophy. The company will face several challenges along the way, with the first being patient recruitment. Will young patients even want to know if they have the disease?
Clinical research has benefited from several advancements in recent decades. Expanding access to information has empowered patients to have greater autonomy in their care and a voice during the development process. Personalized medicine has given rise to promising new therapies treating smaller, more targeted populations. And the number of clinical trials leveraging virtual health tools and mobile technology is increasing. But seismic challenges still remain.
In September 2018, the FDA issued a new draft guidance for industry: Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance. Here, we summarize the differences between the two documents and highlight any significant new elements introduced in the most recent material. Of note, the 2018 guidance is more compact and streamlined than its 2010 predecessor, also evident by a fewer number of total pages (36 vs. 50 in the 2010 version).
U.S. Food and Drug Administration (FDA) requirements specify that packaging and distribution systems must protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.
In line with the FDA’s plans to address the opioid crisis, research groups, pharmaceutical and biotech companies, and medical device manufacturers have increased efforts to develop non-opioid treatments for acute and chronic pain. Read more to understand the scientific, project management, and public health hurdles with these new efforts and how to overcome them.
A small pharmaceutical company was approaching the final phases of a large Phase 3 global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.
Understanding the primary cost drivers for dermatology clinical studies can be daunting for emerging biopharma companies. IQVIA Biotech developed this guide to help small dermatology sponsors better understand the nuances of clinical outsourcing from a financial perspective.
“Configurable” and “customizable” are two commonly used descriptors for interactive response technology systems that support clinical trials. Interpretations of these terms can vary widely. This webinar discusses definitions and system functionality in the context of configurable and customizable and includes systems development life cycle (SDLC) methodologies, the impact on timelines and cost, and common applications in interactive response technology (IRT) system designs.