This white paper addresses the growing interest in quality in clinical trial execution and how workflows play an essential role by building in the steps needed to comply with TMF guidelines, reducing downstream problems. This proactive strategy limits issues caused by siloes, yielding process improvements measurable by performance metrics.
This white paper focuses on defining and expanding the definition of study startup, an element of clinical trials that is gaining attention because it offers the greatest opportunity to improve quality while compressing clinical trial timelines.
The cloud has made anywhere/anytime, centralized monitoring (adaptive-on-site and off-site) of all risk-related trial factors a seamless reality. Looking ahead, the cloud can integrate centralized monitoring, risk management measures, and predictive analytics. It can also create risk repositories, to keep trial costs in check and optimize better quality results for life saving therapies.
As pharmacovigilance adopts next-generation technology by leveraging artificial intelligence (AI) and the cloud, new possibilities are opening up for knowledge generation – and thus value – from the data collected and processed. This paper looks at three important developments around drug safety data and their analysis and how industry is prepared for them.
Just as patients have a stronger voice in today’s healthcare marketplace, that voice should resonate earlier in the drug development process. By adopting a patient-centric approach during protocol design and in day-to-day study management, sponsors can expect improved patient enrollment and retention, as well as a cleaner study with definitive outcomes.
In this paper, ICER’s influence over the payer and manufacturer spheres is evaluated through primary research with these two groups of stakeholders. A secondary budget impact analysis is also conducted in order to estimate the potential savings to the US healthcare system if ICER’s cost effective prices were implemented across a selection of therapeutic areas.
How to develop and deploy novel technologies to reduce patient burden and increase engagement.
The percentage of oncology patients participating in clinical trials is remarkably low: 8.1 percent according to a recent meta-analysis. Read a new report from Syneos Health that shares how enrollment rates and study timelines can be vastly improved by understanding the patient pathway and working to meet patients where they are as they travel along it. The report shares actionable insights for how to meet patients at the right point in their journey – from understanding the influence of emotional pathways of the patient to selecting and priming sites.
To control costs, improve efficiency, and successfully bring more drugs to market—life-changing, life-saving drugs—pharma and biopharma companies need to follow the lead of the financial industry and forward-thinking health systems. Here, we discuss how a data-driven approach to clinical trials—from patient recruitment to post-regulatory approval—can put an end to missed deadlines, failed studies, and wasted time and money.
Dr. El Mustapha Bahassi, Associate Director of Clinical Laboratories at Medpace gives an overview of Central laboratories and the evolving world of immuno-oncology as well as current immuno-oncology biomarkers and detection methods.
|
|
|
|
|
|
|
|
|