Increasingly central in the course of drug development is the inclusion of observational studies, including registries, which provide insights missing from traditional interventional studies.
This white paper discusses the role of the pharmacy in a modern day Phase I clinical research unit and its role in understanding the safety and pharmacology of a drug before Phase II can begin.
In the first annual Patient Adherence Influence Report, Adheris Health and inVentiv Health Consulting set out to understand the most influential factors driving patient adherence or non-adherence and to answer the question: Will the patient cross the finish line at the retail pharmacy, or will he or she walk away?
This white paper represents a compilation of industry best practices for designing, implementing and leveraging randomization and trial supply management (RTSM) software in clinical trials.
Read how utilizing electronic data capture systems ─ including eCOA ─ and training site raters, subjects and caregivers are important tools to ensure high quality data capture in rare disease research.
A discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.
Review the need for rater training in clinical trials and review publications that report data on rater characteristics, training modalities and outcomes in terms of accuracy and reliability of clinical outcomes data.
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.
This requirement to submit promotional material in eCTD will add complexity and more room for error, making it all the more important to prepare for potential challenges.
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.
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