thought leadership

JULY 15, 2024

The term Functional Service Provider (FSP) concept is highly regarded in the field of clinical research. With drug discovery and clinical trials becoming more complex, pharmaceutical firms and research organizations are searching for flexible and customized solutions.

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Drug Discovery World

JUNE 25, 2024

A new study demonstrates that AI-powered digital twin solutions can potentially replace the standard-of-care (SOC) control arm of a clinical trial. Diana Spencer, Senior Digital Content Editor, DDW The post AI digital twins could replace control arm in clinical trials appeared first on Drug Discovery World (DDW).

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PPD

JUNE 20, 2024

Acceleration in every step of clinical research is critical to pharmaceutical developers. Yet, today’s clinical research sponsors face significant challenges. Rather than accepting the persistent delays in clinical research as disruptive, yet unavoidable, we believe they underscore the need for greater efficiency.

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ProRelix Research

MAY 15, 2023

Clinical Research Organizations (CROs) are companies that provide support to the pharmaceutical and biotech industries by managing various aspects of the drug development process and conducting clinical trials. appeared first on ProRelix Research.

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Drug Discovery World

MARCH 23, 2023

A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. For example, the regulatory and ethics reviews of clinical trial applications will be integrated.

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Drug Discovery World

MARCH 15, 2024

In addition to Allyx’s continued clinical development of ALX-001 in Alzheimer’s disease, the company has announced an expansion into Parkinson’s disease clinical research with the opening of an Investigational New Drug Application with the US Food and Drug Administration (FDA).

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Drug Discovery World

MAY 14, 2024

The study examined the motivators and deterrents of clinical trial participation among ethnic minorities and outlined strategies sponsors can utilise to minimise deterrents and promote diversity in their research. “Diversity in clinical trials isn’t a nice to have, it’s a medical necessity.

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Drug Discovery World

NOVEMBER 8, 2023

Deepika Khedekar , Associate Centralized Clinical Lead at IQVIA, explains how artificial intelligence could make clinical trials more accurate, accessible and standardised. Tapping into the capabilities of AI One reason AI may accelerate clinical trials is its ability to rapidly process and analyse vast amounts of data.

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Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

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Advarra

AUGUST 8, 2024

The EU AI Act’s implications extend into clinical research, 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. Here are some key requirements for “high risk” AI systems as they relate to clinical trials.

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Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research 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? over this period.

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Drug Discovery World

SEPTEMBER 18, 2023

Against this backdrop, the Government & Public Health Solutions team at ICON will execute a Phase IIb clinical trial to assess the relative efficacy of a next generation Covid-19 vaccine compared to currently approved/authorised Covid-19 vaccines in the prevention of symptomatic, PCR confirmed SARS-CoV-2 infection.

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Vial

MARCH 6, 2024

The field of clinical research is a dynamic and rapidly evolving one. One way to ensure that you are at the forefront of these developments is by attending clinical research conferences. AACR, founded in 1907, is the world’s oldest and largest professional organization dedicated to advancing cancer research.

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Drug Discovery World

MARCH 1, 2023

The new Liverpool Clinical Research Facility (CRF) unit has opened at the new Royal Liverpool University Hospital thanks to £5.3m ($6.4m) funding from the National Institute for Health Research (NIHR). This design means the unit can conduct Phase I human trials.

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Drug Discovery World

MARCH 6, 2023

The Duke Clinical Research Institute (DCRI) and Protas, led by Oxford University clinical trialist Professor Sir Martin Landray, will collaborate to develop new approaches to large randomised clinical trials.

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Drug Discovery World

OCTOBER 16, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%. It will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety.”

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Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.

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Antidote

JULY 27, 2023

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.

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Antidote

MAY 31, 2023

IWRS, IVRS, and IRT systems are an important part of the clinical research process, as they are used to manage patient enrollment, randomization, drug supply, reporting, and more during clinical trials.

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Drug Discovery World

DECEMBER 7, 2022

Data analytics company Phesi analysed 2,358 clinical trials involving collagen. In the first 10 months of 2022, there were more than 225 new trials, compared with 125 in 2012. Phesi’s analysis shows that just 27% of trials received industry funding. Phesi’s analysis shows that just 27% of trials received industry funding.

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Drug Discovery World

MARCH 31, 2023

Clinical trial technology platform Inato, based in Paris, France, has closed a $20 million Series A funding from investors including Cathay Innovation, Obvious Ventures, La Maison and Top Harvest Capital. Today, 70% of clinical research happens at the same 5% of sites, and only 5% of patients participate in a clinical trial.

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PPD

JUNE 24, 2024

In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.

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Drug Discovery World

APRIL 14, 2023

Clinical trials are, undoubtedly, an essential part of the drug development process, providing us with valuable information about the safety and efficacy of new treatments and therapies. of participants 2 Covid-19 vaccination trials. First, it can lead to delayed approval of drugs for minority populations.

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FDA Law Blog: Biosimilars

MARCH 29, 2024

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. The vast majority are for drugs. GAO reports that BIMO inspections peaked in 2017 when FDA was able to complete over 970 visits.

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Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

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Vial

DECEMBER 4, 2023

Clinical research is an integral component of the healthcare ecosystem. The success of clinical research hinges crucially on patient participation; however, attracting and retaining participants can often pose significant challenges. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,

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Advarra

SEPTEMBER 14, 2023

In the clinical research 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.

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Drug Discovery World

MAY 17, 2023

In the In Conversation With series, a part of the free DDW podcast, DDW speaks with members of the drug discovery industry about their work and how it helps turn science into business. In this latest episode, DDW’s Megan Thomas is in conversation with Dr Michael Pace, Global & Strategic Feasibility Expert at Rho.

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Olympian Clinical Research

MARCH 19, 2024

Clinical trials are essential for advancing medical knowledge and developing new treatments that can improve patient care and outcomes. Participating in a clinical trial is a significant decision that can have profound benefits, not only for the individual participant but also for future patients and the broader medical community.

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Drug Discovery World

APRIL 10, 2023

RESP-X, Infex Therapeutics’ anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients, has shown a promising interim safety and tolerability profile in its ongoing first-in-human Phase I clinical trial.

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Drug Discovery World

JANUARY 5, 2024

Kyverna Therapeutics has revealed plans to progress to Phase II trials of KYV-101 for multiple sclerosis (MS) following a green light from the US Food and Drug Administration (FDA). The post CAR-T therapy could “alter the treatment paradigm” of multiple sclerosis appeared first on Drug Discovery World (DDW).

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Drug Discovery World

FEBRUARY 6, 2024

The first UK patients have received an mRNA cancer therapy – mRNA-4359 – as part of a Phase I/II clinical trial investigating its potential for treating melanoma, lung cancer and other solid tumour cancers. The trial is sponsored by Moderna through the Moderna-UK Strategic Partnership.

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Conversations in Drug Development Trends

JULY 9, 2024

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.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

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Vial

JUNE 24, 2024

The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery.

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Drug Discovery World

OCTOBER 3, 2023

In pharmaceutical development, collaborating with multiple Contract Development and Manufacturing Organisations (CDMOs) and Contract Research Organisations (CROs) poses potential hurdles – from poor communication to delays, errors, and inconsistent feedback during the progression from preclinical to formulation optimisation and clinical trials.

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PPD

AUGUST 16, 2023

The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinical trial (DCT) models. At the end of 2022, the PPD clinical research business of Thermo Fisher Scientific surveyed key leadership and staff on the frontline of clinical trial execution across the industry.

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