Parexel, JFCR ink agreement to accelerate access to oncology clinical trials in Japan
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 16, 2024
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9 Ways Worldwide Optimizes Clinical Development for Your Biotech Growth Journey
Worldwide Clinical Trials
AUGUST 15, 2023
Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations.
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The Power of Personalization Amid the Changing CRO Landscape
Worldwide Clinical Trials
DECEMBER 7, 2023
Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. What Differentiates Mid-Size CROs?
Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China
Pharma Mirror
JUNE 8, 2022
According to the Endpoints ASCO session: “China and the US are the world’s largest oncology research destinations, and the. The post Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China appeared first on Pharma Mirror Magazine.
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IISc researchers find picolinic acid’s broad-spectrum antiviral abilities, scouts for partners in pharma companies
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 3, 2023
Researchers at the Indian Institute of Science (IISc) have found that picolinic acid, a natural compound produced by mammalian cells, can block several disease-causing viruses such as SARS-CoV-2 and influenza A viruses. The Institute is now looking for partners in pharma companies to pursue further clinical development of the findings.
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MASH Clinical Trials: New Approaches and Methodologies
XTalks
DECEMBER 10, 2024
The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinical trials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinical trials.
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Why Should Companies Use Digital Endpoints Across Clinical Development?
XTalks
MAY 28, 2024
The traditional clinical trials model is facing scrutiny. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research.
Increasing patient engagement with UK clinical trials
pharmaphorum
NOVEMBER 17, 2020
Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. Improving the design of commercial research by listening to the patient voice.
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Leveraging Genetic Testing for Enrolling Rare Disease Trials
Worldwide Clinical Trials
JANUARY 24, 2024
Much of what we discuss I covered in my presentation, “Leveraging Genetics to Support Rare Disease Clinical Trials,” at last year’s World Orphan Drug Congress (WODC) EU. In my capstone, I focused on how, if, and when genetic counselors discuss clinical trials with their patients in the context of a counseling session.
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Bridging Gaps in Rare Disease Clinical Trials: Insights from Collaborative Success in Pompe Disease Research
XTalks
JULY 29, 2024
Orphan drug development poses many challenges that are unique to rare diseases, including recruitment in small patient populations, variable progression with heterogenous clinical manifestations and limited understanding of disease progression and natural history.
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What Are the Top Oncology Clinical Trial Trends Through the Lens of ESMO?
XTalks
JANUARY 17, 2024
In this Xtalks Spotlight edition, Xtalks spoke with two oncology clinical research experts from Fortrea , Laura Vidal, MD, Medical Head of Oncology, EU (European Union), and Ken Morrison, PhD, Global Head of Strategic Delivery & Growth Oncology. It’s very positive and it’s going to help move forward the pathway for new drugs.”
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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma
Pharmaceutical Technology
MAY 22, 2023
SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinical trial in June 2022.
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How Can You Manage the Complexity of Early Phase Clinical Development?
XTalks
JUNE 4, 2024
In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”
Creating Inclusive Clinical Trials: Why Authenticity and Patient Stories Are Essential
XTalks
OCTOBER 4, 2024
The push to increase diversity in clinical trials has gained momentum, but true progress requires more than regulatory mandates. In this webinar, industry leaders and patient advocates discussed how authenticity and the patient voice can be leveraged to enhance diversity in clinical trials.
To build diversity into clinical trials, collaborate at the community level
pharmaphorum
AUGUST 24, 2022
Diversity in clinical trials is a “scientific imperative”, but how can industry bridge the gap between “why” and “how”? Removing barriers to clinical trial participation for underserved groups is an essential part of addressing health inequalities. Clinical trial participation, she went on, was vital.
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Complexity in Early Phase Clinical Trials with Dr. Oren Cohen?
Clinical Trial Podcast
SEPTEMBER 26, 2022
To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development. Cohen to the Clinical Trial Podcast.
Now what? The future of clinical trials after the pandemic
pharmaphorum
MAY 27, 2021
Sheila Rocchio highlights four key areas life sciences must improve on as an industry to drive real change in how clinical trials are conducted. With the availability of all this rich data from specialty devices and labs, researchers can gain a variety of insights. Next generation of decentralised trials.
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Clinical Trials For All Campaign: Converging Trials and Healthcare
XTalks
AUGUST 22, 2023
Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?
Clinical Trials Day 2021: Reflecting on a Challenging Year That’s Made the Industry Stronger
XTalks
MAY 20, 2021
Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.
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Psychiatry Clinical Trials: Inclusive, Patient-Centric Approaches for Mental Health Research
XTalks
DECEMBER 19, 2024
Despite advancements in neuroscience and psychiatry, clinical trials for mental health conditions such as major depressive disorder (MDD), schizophrenia, bipolar disorder and generalized anxiety disorder face unique challenges. Finally, psychiatry clinical trials must also address the variability in treatment responses.
Increasing patient engagement with UK clinical trials
pharmaphorum
FEBRUARY 11, 2021
Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions.
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Interview: Is global AI regulation really revolutionizing pharma and clinical trials?
Outsourcing Pharma
APRIL 29, 2024
OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.
Unlocking the potential in rare disease research with decentralised trials
pharmaphorum
JANUARY 19, 2021
A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease.
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Merck and Moderna partner to develop and sell cancer vaccine
Pharmaceutical Technology
OCTOBER 14, 2022
It is currently being assessed in combination with Merck’s anti-PD-1 therapy, Keytruda, as an adjuvant treatment for high-risk melanoma patients in a Phase II clinical trial being conducted by Moderna.
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Type 2 Diabetes: Challenges & Emergent Strategies for Clinical Research
Worldwide Clinical Trials
JULY 29, 2024
Clinical development programs must acknowledge the complexity and variability of obesity as a condition. Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research.
Why Proactive AME Studies are Critical to Accelerating Your Approval Journey
Worldwide Clinical Trials
FEBRUARY 21, 2024
During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide Clinical Trials.
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IQVIA’s report card for clinical trial diversity: must do better
pharmaphorum
NOVEMBER 11, 2022
The lack of diversity in clinical trials has been a topic of debate for decades, but was thrust into the spotlight as the impact of the pandemic on poorer, less educated and ethnically diverse populations became even more apparent. The post IQVIA’s report card for clinical trial diversity: must do better appeared first on.
Examining COVID’s impact on clinical research participant diversity
pharmaphorum
FEBRUARY 21, 2022
The clinical research industry has long struggled with participant diversity. One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinical trial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S.
The State of Pediatric Clinical Research: An Interview with Paidion CEO Barry Mangum, PharmD, FCP
Camargo
JULY 30, 2021
Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? So I’ve been working in that space about 43 years.
What Successfully Recruited Post-COVID Oncology Trials Have in Common
Worldwide Clinical Trials
OCTOBER 31, 2023
Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.
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How Worldwide and Every Cure Are Using AI To Unlock New Rare Disease Treatments
Worldwide Clinical Trials
NOVEMBER 21, 2023
As a provider of end-to-end clinical development solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis. At Worldwide, we deliver full-service clinical development to support drug approval and commercialization.
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Reimagining CRO Partnerships: The Emerging Preference for Midsize Organizations
Worldwide Clinical Trials
APRIL 15, 2024
As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs.
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Why Including Patients in FDA Engagement Will Benefit Your Trial
Worldwide Clinical Trials
AUGUST 23, 2023
Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.
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Gilead receives EC marketing authorisation for HIV treatment in children
Pharmaceutical Technology
NOVEMBER 30, 2022
The latest development is based on data obtained from an open-label clinical trial of Biktarvy. According to the trial findings, the treatment was demonstrated to be effective and well-tolerated through 24 weeks in adolescents who are virologically suppressed and children with HIV infection.
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6 Principles of Our Rare Disease Methodology That Drive Success for Our Sponsors
Worldwide Clinical Trials
MAY 14, 2024
By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. Contact us !
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3 Best Practices for Patient Engagement in Clinical Trials
XTalks
NOVEMBER 1, 2023
The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research.
Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations
XTalks
NOVEMBER 19, 2021
Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.
Providing the Blueprint for Gen AI Adoption in Clinical Trials
ACRP blog
OCTOBER 10, 2024
It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinical trials operator will be more than happy to resign to machines. Integrating AI tools into complex workflows will require time and understanding.
Ora partners with North West London Clinical Trials Alliance to enhance ophthalmology treatments
Outsourcing Pharma
JULY 12, 2023
Ora, a clinical research organization (CRO) for ophthalmology pharmaceutical and device development, has partnered the North West London Clinical Trials Alliance, to improve the quality and access to clinical research in the region.
Astellas to support development of Taysha’s gene therapy programmes
Pharmaceutical Technology
OCTOBER 25, 2022
Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). Astellas will also receive specific rights linked to any possible change of Taysha’s control.
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Diversity Action Plans (DAPs) in Clinical Trials Are No Longer a “Nice-to-Have” — Are You Ready?
XTalks
NOVEMBER 19, 2024
In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.
Clinical Data Management Experts Share Insights on Modern Digital Clinical Trials
XTalks
MAY 6, 2022
In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. In addition, 43.4 percent were using or piloting omics data.
What Do Patients Really Think About How They Are Being Paid During a Clinical Trial?
XTalks
SEPTEMBER 25, 2024
Patient-centricity isn’t a catchphrase in clinical trials—it’s a guiding principle for improving patient experiences. One of the most critical aspects of this is how patients are compensated for their participation in trials. Meghan Harrington VP, Clinical Trial Financial Management Medidata Alicia C.
Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development
FDA Law Blog
NOVEMBER 10, 2024
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
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