These clinical packaging strategies can be used to help successfully manage the supply of an expensive drug product throughout the duration of clinical testing. Without doing so, there could be costly interruptions or extended delays that would have a devastating impact on a company’s timeline to commercialization.
This article reviews current trends in Real-World Data (RWD) collection and how clinical trial sponsors can generate significant returns on investment by utilizing innovative technologies to overcome the perceived challenges that hinder some patient-centric initiatives.
Genomic- based biomarkers are powerful tools used to assess tumor mutational burden, production of novel or neo- antigens and hallmarks of genomic instability, which may be useful as measures of response or resistance to immune therapies.
How site-focused eClinical tablet applications can be effective vehicles for patient engagement.
With proactive planning and validated processes, NK cell functional analysis can support a range of various immunotoxicity endpoints in a study, from discovery and development to the clinic.
The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.
See how your colleagues in the drug development industry could surmise our participants’ aggregate answers from a survey of aimed at gaining an understanding of patient mindset and design more effective recruitment strategies.
Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success. The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.
Sue Mann, Managing Director and QP Consultant of Sue Mann Consultancy answers your questions regarding the QP process.
This article discusses ways to adopt patient-centered drug development, changing the corporate culture and trial design, understanding patient needs and incorporating them into trials, and leveraging technology to conduct remote patient-centric clinical trials.
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