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Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinicalresearch. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.
Clinicalresearch is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. The post The Value of ClinicalResearch first appeared on Advarra.
The EU AI Act’s implications extend into clinicalresearch, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Non-EU companies must comply with the AI Act if their AI systems are used in the EU market.
The substantial value of organoids is becoming increasingly recognised by supportive government initiatives developing novel drugs, with a growth rate of 22 percent between 2023 and 2030 and a market size predicted to reach over US $6.5 billion by 2030. This can aid in the development of safer, more effective therapeutic strategies.
Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinical trials.
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.
2024 has been a year of growth and evolution in clinicalresearch. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinicalresearch, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.
Although clinical trials provide useful information regarding the efficacy and safety of new drugs, biological products, and medical devices, the information captured through them is not all-encompassing. Limited patient populations, […] The post Post-Marketing Surveillance Strategies appeared first on ProRelix Research.
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
It’s important to recognize that for many large pharmaceutical and biotechnology companies, compounds that have the potential to treat a rare disease of significant unmet need might become lower strategic priority than those that have mass market potential.
Chief Executive Officer Steve Herne has spent more than 25 years in clinicalresearch, with senior roles at WCG, Bioclinica and Covance. AI with a human purpose Herne speaks about AI in clinicalresearch with pragmatic focus. Unlearn is one of the few companies applying this approach at scale.
Introduction Contract Research Organisation (CRO) outsourcing has become a vital strategy for pharmaceutical and biotechnology companies aiming to optimise clinicalresearch and drug development.
Consider the PRECLUDE study – a clinicalresearch study for patients with episodic migraines. What is a ClinicalResearch Study? A clinicalresearch study is carefully designed medical research with human volunteers to learn more about investigational drugs. About Migraines.
Acceleration in every step of clinicalresearch is critical to pharmaceutical developers. Yet, today’s clinicalresearch sponsors face significant challenges. Rather than accepting the persistent delays in clinicalresearch as disruptive, yet unavoidable, we believe they underscore the need for greater efficiency.
We are thrilled to announce that the PPD clinicalresearch business of Thermo Fisher Scientific is getting a brand refresh! Our new visual identity will align more closely with Thermo Fisher’s style, while still retaining elements unique to our PPD clinicalresearch business. What’s changing? Ready to unlock efficiencies?
In the clinicalresearch space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Searching for overlap might allow the investigational product to have a more rapid marketing authorization in multiple regions. Japan, and China.
Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinical trials. Data from these studies can accelerate research timelines and improve trial planning throughout the product life cycle.
FSP solutions are being more frequently utilized by biotech companies Biotech companies employ contract research organizations (CROs) to handle trial-related functions and services, often delivered through a full-service outsourcing (FSO) model, an FSP model or a mixed model combining both. FSP outsourcing is growing faster than FSO.
Distinguishing the Roles of Preclinical vs. Clinical CROs in ClinicalResearch Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? billion in 2022 and is projected to reach US$10.2
At Olympian ClinicalResearch we’ve gotten a chance to work with countless Schizophrenia patients over the years through our clinical trials, and we know just how untrue many of the common assumptions about Schizophrenia really are. . Myth #2: People with Schizophrenia are violent. Learn More.
As advancements in medical science progress, clinicalresearch and development (R&D) are subject to more sophisticated and complex study designs and protocols that require precise global coordi | Market Insights: What’s Driving the Shift Toward FSP Models in Clinical Development?
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 Backed by more than 30 years of support for clinical and marketed products, we know what it takes to solve your specific challenges.
These strategies are critical for enhancing the overall success of GLP-1 therapies in clinical practice. GLP-1 Drug Class: Market Overview The market for GLP-1 medications is expanding, with several establishing options and numerous promising therapies on the horizon.
The enterprise of delivering life-changing medicines to patients involves a complex ecosystem, and in many ways, three key players reside at the core: drug sponsors, the contract research organizations (CROs) that support them and the clinicalresearch sites directly engaging with patients in the trial.
In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.
The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinicalresearch business of Thermo Fisher Scientific.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. To find success among the competition, sponsors must have access to the necessary expertise and resources to approach this burgeoning market.
In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinicalresearch and drug discovery. It is critical for drug developers to partner with a knowledgeable CRO partner like the PPD clinicalresearch business of Thermo Fisher Scientific.
Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Growth of the FSP market is steadily increasing.
In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.
Finding the right medication can be a frustrating process, though, since there’s no “one-size-treats-all” medication for depression on the market. The post Battling Depression In A World Of Isolation: Tips For Managing COVID Depression appeared first on Olympian ClinicalResearch.
The PPD clinicalresearch business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.
Many of the life-changing medical treatments that are available for patients have all been tested through a research study. There’s no doubt that research volunteers play a significant role in getting these vital solutions out on the market for the people in need. Enrolling Studies.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
The life sciences industry is one of the most rigorously regulated sectors globally, prioritising patient safety during clinical trials and post-marketing phases. All trials must comply with country-specific regulations set by regulatory bodies.
However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs. Study sponsors need quality results as quickly as possible to maximize profit-generation opportunities in the market.
With up to 90 percent of assets never making it to market when competition is at an all-time high, it is worth discussing how AI-driven approaches might help set a stronger foundation for possibilities downstream. This has led drug developers to unintentionally limit their potential within chosen therapeutic spaces.
The PPD™ clinicalresearch business of Thermo Fisher Scientific helps clients create all manner of flexible outsourcing solutions, many of which are detailed in our recent white paper, “Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships.”
If you’re starting to explore marketing your medical device in the European Union (EU) or have a medical device that is currently CE Marked, you’re becoming familiar with the term ‘CER’ or Clinical Evaluation Report. In this post, we’ll explore the fundamentals of the Clinical Evaluation Report (CER). Let’s get started.
According to research commissioned by the PPD clinicalresearch business of Thermo Fisher Scientific, 55% of respondents reported patient recruitment in clinical trials as the top challenge facing their organization, followed closely by increasing trial complexity.
The clinicalresearch industry, like many others, has continued to be challenged by staff turnover in recent years. Clinicalresearch organizations everywhere are seeing an influx of employees leaving their positions to go elsewhere. This can lead to further delays and costs.
Choosing to participate in a clinicalresearch study is a very personal decision, and people choose to participate in clinicalresearch studies for a variety of reasons. We know that participating in a research study may seem overwhelming and intimidating, but sometimes the potential benefits far exceed any uncertainty.
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