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

Worldwide Clinical Trials

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments.

Clinical Research 173

Clinical Research Trials Research Clinical Trials 173

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 2, 2024

With a focus on equipping regulators with advanced skills, the CDSCO conducted 23 residential training programmes tailored to address critical aspects such as […]

Regulation 188

Regulation Drugs Clinical Trials Clinical Trials 188

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

pharmaphorum

JANUARY 25, 2021

The clinical research community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021. Yet the most important stakeholder to engage is the patient.

Clinical Research 124

Clinical Research Research Clinical Trials Clinical Trials 124

BioPharma Reporter

JANUARY 17, 2023

In 2022, the UK continued to have a signficant footprint in ATMP clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022, according to a new report.

Clinical Research 123

Clinical Research Research Trials Regulation 123

XTalks

FEBRUARY 22, 2021

Clinical research is part of a growing industry that provides individuals with rewarding career options and a ladder to climb. Working in the clinical trials industry allows clinical researchers to work with patients and bring new drugs to market. There are many professions under the clinical research umbrella.

Clinical Research 98

Clinical Research Clinical Research Coordinator Research Clinical Trials 98

Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

Clinical Research 105

Clinical Research Research Clinical Trials Clinical Trials 105

ACRP blog

SEPTEMBER 12, 2024

ACRP reached out to experts from graduate programs in clinical research for a snapshot of how education in this field, especially at the master’s degree level, is holding up amidst rapidly evolving changes in the research enterprise itself. Some are recent undergraduates and others mid-career professionals or clinicians.

Clinical Research 110

Clinical Research Research Clinical Trials Clinical Trials 110

Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

Clinical Research 98

Clinical Research Research Trials Clinical Trials 98

Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

Clinical Trials 147

Clinical Trials Clinical Trials Regulation Trials 147

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 24, 2023

An MoU […]

Regulation 180

Regulation Production Drugs Clinical Trials 180

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 11, 2023

Clinical Establishment (CE) Regulation should be adopted on priority basis because it stipulates eligibility and qualification of personnel running a lab, standards or guidelines on the infrastructure and testing facilities.

Regulation 188

Regulation Clinical Trials Clinical Trials Clinical Research 188

Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. 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.

Clinical Research 98

Clinical Research Research Compliance Clinical Trials 98

VirTrial

AUGUST 21, 2021

A telemedicine platform intended for clinical trials must provide broader functionalities to accommodate the various needs of sponsors, CROs, patients, clinicians, investigators, research site staff, and regulators, as well as meet international regulatory requirements. This post originally appeared on Signant Health.

Clinical Research 97

Clinical Research Research Clinical Trials Clinical Trials 97

XTalks

SEPTEMBER 9, 2024

Diversity, equity and inclusion (DEI) have become important elements in the landscape of clinical research. Xtalks spoke with Stacy Weil, DHI, Senior Vice President, Business Operations and Patient Centricity, Premier Research, to gain insights into incorporating DEI practices and plans in clinical research.

Clinical Research 101

Clinical Research Research Clinical Trials Clinical Trials 101

ACRP blog

OCTOBER 19, 2022

In the turbulent waters of the clinical research workforce, with high turnover and burnout circling like relentless sharks, several leading organizations have found ways to navigate their way through and around the worst of the storm. It required us to look at student frustrations in finding jobs in clinical research,” Traynor says. “We

Clinical Research 98

Clinical Research Research Clinical Trials Clinical Trials 98

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 16, 2023

In the search for a treatment for Alzheimer’s disease, researchers have zeroed in on a protein with protective effects. A new study reveals how cholesterol and inflammation in different types of human brain cells interact with a protein called ABCA7, which regulates how molecules pass through cell membranes.

Protein 246

Protein Scientist Regulation Research 246

pharmaphorum

MAY 28, 2024

Navigating the ethical landscape of clinical research with minors: exploring the HHS and FDA regulations around parental permission, child assent, and adolescent autonomy under CFR 46. Learn how to ethically and legally involve young participants in studies.

Clinical Research 69

Clinical Research Research Regulation 69

Pharmaceutical Commerce

AUGUST 28, 2024

The latest news for pharma industry insiders.

Clinical Research 103

Clinical Research Regulation Research 103

Velocity Clinical Research

DECEMBER 30, 2024

A new Fierce Biotech article features insights from Paul Evans on what to expect for clinical research in 2025. Topics include rising costs and uncertain regulations, as well as the continued emergence of site networks, AI-driven efficiency (with technology built by trial sites, for trial sites), and enhanced diversity initiatives.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

ACRP blog

JANUARY 28, 2025

Collection of sensitive personal data is a cornerstone of clinical research involving drugs and medical devices. However, if the personal data relates to European Union (EU) or United Kingdom (UK) residents, this raises particular legal and compliance issues due to the General Data Protection Regulation (GDPR).

Compliance 59

Compliance Research Clinical Trials Clinical Trials 59

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 18, 2022

With less than ten days to meet the deadline mandating the registration of Assisted Reproductive Technology (ART) clinics, ART banks and Surrogacy Clinics to be eligible to conduct counselling and procedures, five more States are yet to report to the Centre on appointment of appropriate authority.

Regulation 189

Regulation Clinical Trials Clinical Trials Clinical Research 189

Outsourcing Pharma

JUNE 14, 2023

In a bid to address the high demand for clinical research talent, Advanced Clinical is hosting an innovation theater at DIA Global in Bostonâs Convention and Exhibition Center.

Clinical Research 88

Clinical Research Research Regulation Marketing 88

FDA Law Blog

NOVEMBER 10, 2024

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S. The seven awardees included six early-stage trials (e.g.,

Production 69

Production Clinical Development Development Regulation 69

XTalks

APRIL 13, 2022

“Pediatric rare disease trials, by combining both the rarity of the rare disease as well as the restricted number of pediatric patients, do highlight some challenges,” said Dr. Gregory Hale, Senior Medical Director, Hematology and Oncology, of the global contract research organization (CRO) Medpace. Aspects of Pediatric Medical Research.

Clinical Trials 98

Clinical Trials Clinical Trials Clinical Research Trials 98

Rethinking Clinical Trials

OCTOBER 27, 2022

Duke Clinical Research Institute. Chief Research Technology Strategist. ePatient and Security Researcher. Patients use the internet to search for answers, and researchers use the internet to search for new solutions. Researchers need to overcome the risks of online tools and increase the benefits.

Clinical Research 100

Clinical Research Research Clinical Trials Clinical Trials 100

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

Clinical Trials 243

Clinical Trials Clinical Trials Drugs Regulation 243

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 7, 2024

A study suggests eating later in the day can directly impact our biological weight regulation in three key ways: through the number of calories that we burn; our hunger levels; and the way our bodies store fat. link] With obesity now affecting hundreds of millions of people worldwide, this is a valuable insight into how […]

Regulation 245

Regulation Clinical Trials Clinical Trials Clinical Research 245

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 8, 2023

The new regulations, which were first announced in May, are a world first. Each cigarette sold in Canada will have to come with an individual health warning that “cigarettes cause impotence” and cancer, and that there is “poison in every puff” under new rules that came into effect Tuesday.

Regulation 246

Regulation Clinical Trials Clinical Trials Clinical Research 246

Outsourcing Pharma

MARCH 29, 2022

A leader from the healthcare technology company discusses the conflictâs impact on the region and beyond and the need to better guard against interruptions.

Clinical Research 101

Clinical Research Research Regulation Marketing 101

Advarra

NOVEMBER 14, 2024

A globally diverse DMC ensures the trial adheres to local regulations while maintaining high ethical standards. This collaborative spirit can lead to developing novel methodologies and strategies for monitoring and evaluating clinical trials, ultimately advancing the field of clinical research.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Clinical Research 97

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 26, 2022

The National Medical Commission (NMC), the apex medical education regulatory body, has come out with draft Establishment of Medical College Regulations, (Amendment), 2022 ushering changes in rules for setting up medical institutes. According to […].

Regulation 188

Regulation Clinical Trials Clinical Trials Clinical Research 188

Advarra

SEPTEMBER 19, 2024

Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinical research encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 23, 2024

Chicago-based Linden Capital Partners and Canada’s Ontario Teachers’ Pension Plan are partnering with Elligo Health Research to launch a platform focused on advancing clinical research. This collaboration aims to leverage Elligo’s expertise in healthcare research, utilizing their innovative approaches to clinical trials.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

XTalks

OCTOBER 29, 2024

Protocols drive every clinical study, guiding research teams from early inception through planning and into the trial’s execution. Clinical trial protocols are also very complex, with detailed schedules of assessments, inclusion/exclusion criteria and scientific reasoning all captured into a single written document.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 19, 2024

Click here Policy & Regulations + Font Resize – DCA Telangana raids & seizes illegally made cough syrups in Hyderabad Peethaambaran […] Home Editorial Services Interview Q&A Chronicle Specials Pharma Mart ePharmail Archives Join Pharma | Login Home > TopNews you can get e-magazine links on WhatsApp.

Regulation 187

Regulation Clinical Trials Clinical Trials Clinical Research 187