XTalks

APRIL 8, 2025

Global rare disease clinical trials face unique challenges due to small patient populations, complex logistics, diverse regulatory environments and cultural differences. Clinical Trial Manager/Sr. These measures enhance recruitment, retention and overall trial success.

Clinical Trials 88

Clinical Trials Clinical Trials Trials Gene Therapy 88

XTalks

JANUARY 16, 2025

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. These stem cells are engineered to develop into dopamine-producing neurons, which are progressively lost in Parkinsons disease.

Trials 104

Trials Clinical Trials Clinical Trials Gene Therapy 104

ACRP blog

JANUARY 14, 2025

Food and Drug Administration (FDA) is highly supportive of clinical trial innovation, including advancing study design, conduct, and reporting within the global ecosystem. A key question is what kind of behavior changes can help us improve as clinical research professionals? To succeed, we must overcome our fears.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

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.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Clinical Research 105

XTalks

NOVEMBER 15, 2024

Syros Pharmaceuticals announced that its cancer drug tamibarotene failed to meet its primary endpoint in the SELECT-MDS-1 Phase III trial. The placebo-controlled SELECT-MDS-1 trial involved 190 patients with complete response rate (CRR) being the study’s primary endpoint. percent and 18.8

Trials 105

Trials HR Immune Response FDA Approval 105

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.

Clinical Research 226

Clinical Research Research Gene Therapy Drugs 226

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 16, 2024

Under […]

Clinical Trials 188

Clinical Trials Clinical Trials Trials Clinical Research 188

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research 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.

Research 147

Research Clinical Trials Clinical Trials Immune Response 147

ACRP blog

MARCH 18, 2025

says David Vulcano, LCSW, MBA, CIP, RAC, FACRP , Vice President, Clinical Research Compliance and Integrity, at HCA Healthcare and author of a recent ACRP White Paper on Responsible Oversight of Artificial Intelligence for Clinical Research Professionals. in April.

Clinical Research 69

Clinical Research Research Compliance Clinical Trials 69

XTalks

OCTOBER 23, 2024

In this episode, Vera spoke with Morgan Hanger, Executive Director of the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinical trials, with an ambitious “Transforming Trials 2030” vision.

Clinical Research 64

Clinical Research Clinical Trials Clinical Trials Life Science 64

Worldwide Clinical Trials

APRIL 8, 2025

In a recent webinar, Challenges of Drug Development in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research.

Research 124

Research Clinical Trials Clinical Trials Trials 124

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research 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.

Research 130

Research Clinical Trials Clinical Trials Immune Response 130

XTalks

APRIL 17, 2025

Their discussion shows how meaningful partnerships, deep listening and unwavering patient-centricity can transform clinical research, trial design and care delivery in rare conditions such as HPP. Early collaborations in clinical trial design enabled both teams to integrate critical patient insights into study protocols.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

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. You have the oversight you need.

Clinical Development 246

Clinical Development Development Compliance Trials 246

Worldwide Clinical Trials

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.

Genetics 189

Genetics Trials Clinical Trials Clinical Trials 189

XTalks

DECEMBER 10, 2024

In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo. Participants received either rilzabrutinib or placebo for 24 weeks, followed by an open-label extension.

Trials 104

Trials Protein Clinical Development Drugs 104

Rethinking Clinical Trials

MARCH 28, 2024

Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. View the Equitable Language Cheat Sheet.

Trials 219

Trials Nurses Clinical Trials Clinical Trials 219

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.

Trials 242

Trials Clinical Trials Clinical Trials Development 242

Worldwide Clinical Trials

JULY 29, 2024

Despite these advancements, challenges for widespread effective care remain due to the heterogeneous patient population, opening the door for further development of treatments for T2D. Obesity is a major factor in the prevalence of T2D, and it is vital to develop T2D treatments with this in mind.

Clinical Research 130

Clinical Research Research Clinical Trials Clinical Trials 130

XTalks

MARCH 12, 2025

Following the success of Issue 3 , which focused on the critical importance of patient diversity in clinical research, Xtalks is thrilled to announce Xtalks Clinical Edge Issue 4. These prominent leaders will share their experiences, strategies and visions about whats next for clinical research.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 13, 2024

With nothing more than a drop of blood, medical specialists could soon have years of advance warning that the disease is developing. As treatments for multiple sclerosis (MS) continue to improve, scientists are looking for ways to spot the condition before symptoms set in. MS affects nearly a million people in the US alone, whose […]

Development 241

Development Scientist Clinical Trials Clinical Trials 241

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 19, 2024

The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinical trial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.

Clinical Trials 189

Clinical Trials Clinical Trials Vaccination Vaccine 189

Velocity Clinical Research

JANUARY 30, 2025

Velocity Clinical Research, the leading multi-specialty clinical research organization, has partnered with Verified Clinical Trials (VCT) to set a new benchmark for patient safety and data quality in clinical trials through a new technological implementation at Velocitys 80+ global sites.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

MARCH 26, 2025

In the fast-evolving field of clinical research, thought leaders do more than just keep up; they lead the charge and shape the direction of the industry. Heres how thought leaders are currently making an impact in clinical research: 1.

Clinical Research 52

Clinical Research Research Branding Clinical Trials 52

ACRP blog

OCTOBER 22, 2024

The clinical research industry plays a vital role in advancing medical knowledge and improving healthcare; however, the increasing complexity of clinical trials has created a perfect storm of challenges for clinical research sites, posing significant risks to the efficiency, effectiveness, and sustainability of clinical trials at large.

Trials 59

Trials Clinical Research Clinical Trials Clinical Trials 59

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 Trials 64

Clinical Trials Clinical Trials Trials Production 64

Worldwide Clinical Trials

MARCH 1, 2024

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. Do you have various stakeholders invested in the success of your development programs?

Trials 195

Trials Production Development Clinical Trials 195

Worldwide Clinical Trials

APRIL 3, 2024

As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution. Are you aware of the challenges you must address for a successful radiopharmaceutical trial? These include ensuring informed consent, particularly around the risks and benefits of participation.

Trials 204

Trials Clinical Trials Clinical Trials Compliance 204

Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Developing treatment biomarkers and diagnostic biomarkers may help achieve these goals.

Development 264

Development Drugs Clinical Trials Clinical Trials 264

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.

Production 69

Production Clinical Development Development Regulation 69

Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials 200

Trials Clinical Trials Clinical Trials Regulation 200

ACRP blog

FEBRUARY 11, 2025

If theres one thing clinical researchers can count on when it comes to regulations and guidance from governing bodies, its change. Its a unique opportunity to not only stay up to date with research initiatives, but also to engage with healthcare research professionals from around the country. This is a sponsored message.

Compliance 59

Compliance Clinical Research Research Regulation 59

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.

Clinical Trials 69

Clinical Trials Clinical Trials Trials Life Science 69

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 25, 2024

The recent regulatory developments to relax clinical trial norms in India are poised to have a significant impact on the pharmaceutical industry and drug pricing. By easing regulations, Indian pharma could see a reduction in the costs associated with human studies.

Clinical Trials 186

Clinical Trials Clinical Trials Trials Drugs 186

Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Developing treatment biomarkers and diagnostic biomarkers may help achieve these goals.

Development 246

Development Drugs Clinical Trials Clinical Trials 246

Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Deltaclinical

DECEMBER 9, 2022

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.

Clinical Research 130

Clinical Research Research Nurses Clinical Trials 130