Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.
This paper is intended as 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.
Clinical supply chain planning is imperative, as it allows you to develop a strategy and best practices for quickly and efficiently delivering goods to support all the needs of the trial. But, where do you begin?
Small and emerging biopharma companies are conducting almost 50% of the clinical trials in the United States today. Unlike “big pharma”, small companies are usually working with lean teams, limited resources, and minimal infrastructure. In this paper, we explore some of the unique challenges for clinical development teams, and solutions that can reduce the pressure on teams and timelines.
New research on how people make decisions about research participation, and new approaches to the question of payments and compensation to participants, bring a new perspective; are payments to participants actually too low? This paper explores this question, and whether we should, in fact, worry much less about restricting compensation for research participants.
Approximately 20% of cancer clinical trials will never be completed, because they fail to enroll enough participants to be able to answer the research question. Read this white paper to learn the impact that participant payments may play on clinical trial recruitment.
The EMA’s qualification opinion on Direct Data Capture (DDC) is a huge regulatory development for the clinical research industry. Read our white paper for a quick understanding of the major points in the opinion, and of how DDC improves data accuracy, monitoring, and more.
A competent Importer of Record is a prerequisite to any successful global clinical trial. The role is vast and the remit wide, covering everything from ensuring imported goods comply with local law and regulations, payment of import duties, tariffs and fees; to risk mitigation and maximizing opportunities to ensure the right drug, gets to the right patient at the right time.
Clinical research generates a massive amount of data. Unfortunately, because of the way most clinical data programs currently work, much of these data are not used to their fullest extent; they are simply filed away. This white paper will focus on the benefits provided by a unique and advanced analytical approach to study monitoring beyond the minimum necessary RBM approach.
- Every year, tens of thousands of clinical trials are initiated. Every year, thousands of those trials falter, and, if corrective action isn’t taken, some may fail to produce usable data. In this white paper, we want to attempt to characterize the scope of the problem facing the drug development industry, and make a case for early, proactive intervention in faltering clinical trials.
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