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The rising impact of biomarkers in early clinical development

Drug Target Review

Prior to being validated, the FDA will still consider biomarkers in the marketing approval process as a reasonably likely surrogate endpoint or candidate surrogate endpoint. Biomarkers can play a crucial role throughout clinical development, especially in early phases.

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How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

PPD

Because biotech companies need to remain flexible and agile while remaining on time and on budget they are harnessing innovations to navigate unexpected drug development challenges and leveraging strategies to fill gaps in resources and expertise. FSP outsourcing is growing faster than FSO.

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The AI model that is changing clinical trial design

Drug Target Review

Chief Executive Officer Steve Herne has spent more than 25 years in clinical research, with senior roles at WCG, Bioclinica and Covance. Unlearn’s digital twins are now in use in both early and late-stage clinical trials, with adoption continuing to grow. Unlearn is one of the few companies applying this approach at scale.

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Leveraging AI Solutions for Clinical Trial Efficiencies

PPD

Click to enlarge Six AI and machine learning considerations for effective clinical trial management 1. Accelerate customer speed to market With a modern and integrated user experience, AI solutions put the right data and insights into the right hands in real time.

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Redefining Acceleration of the Drug Development Journey

PPD

As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. According to the United Nation’s 2024 World Population Prospects data, the global population of those 65 years old and over will grow from 0.8

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Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence

PPD

Real-world data (RWD) and real-world evidence (RWE) have emerged as transformational tools in addressing these hurdles, advancing rare disease drug development. Data from these studies can accelerate research timelines and improve trial planning throughout the product life cycle.

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Leveraging Remote-Based Regional Hubs to Improve Efficiencies and Meet Timelines

PPD

In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6 Expansion into non-footprint countries Many clinical development projects are confined to regions where sponsors have a direct presence.