Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Compliance 40

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 22, 2024

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.

In-Vitro 157

In-Vitro Licensing Licensing Regulation 157

Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Imperical Blog

SEPTEMBER 7, 2023

Avoiding “Customs Chaos” in Clinical Trials Means Working Closely with Your Importer of Record Many global clinical trial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Velocity Clinical Research

AUGUST 18, 2023

Even as a teen in Egypt, Amira Nada was drawn to the idea of clinical research and how it could help people live healthier, richer lives. She decided to focus on patient recruitment to promote diversity in clinical trial populations. Through it all, her commitment to and belief in clinical research never wavered.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Rethinking Clinical Trials

JULY 6, 2023

Over the past several years, a variety of factors have accelerated the need for decentralized trials, including the push to make trials more accessible, the increased speed of science, the possibility of environmentally conscious trials, and the need to be flexible in a rapidly changing world.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Post market research for monitoring drug safety.

Marketing 80

Marketing Research Clinical Trials Clinical Trials 80

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 21, 2024

A unified licensing authority titled as Indian Drug Regulatory Authority (IDRA) will garner the much needed recognition globally like US FDA or EMA, said Dr BR Jagashetty, former National […] India must now move towards looking to merge its Central and state enforcement wings and form a single authority.

Licensing 136

Licensing Licensing Drugs Clinical Trials 136

pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

XTalks

MAY 2, 2022

Lecanemab, the product of Phase IIb clinical research completed by BioArctic and collaborator Eisai, is one therapy making strides this year for Alzheimer’s disease. Lecanemab , the product of Phase IIb clinical research completed by BioArctic and collaborator Eisai, is one such therapy making strides this year.

Clinical Trials 98

Clinical Trials Clinical Trials Antibody Trials 98

pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license.

Trials 105

Trials Clinical Trials Clinical Trials Life Science 105

Cloudbyz

MARCH 17, 2021

Monitoring patient safety during a clinical trial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship between sponsors, sites, researchers, and everyone involved in the clinical trial phases.

Clinical Trials 71

Clinical Trials Clinical Trials Trials Clinical Research 71

ACRP blog

FEBRUARY 21, 2023

Decentralized clinical trial (DCT) elements enabled clinical research to continue during the pandemic, when physical attendance at healthcare facilities was often impossible. Author: Jill Dawson The post Decentralized Clinical Trial Models: Are They Here to Stay? DCT Models: Are They Here to Stay?

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 30, 2023

Even as the Centre has listed the New Drugs, Medical Devices and Cosmetics Bill, 2023 to be tabled in Parliament during the current session, industry members are apprehensive that the new bill may mean centralisation of licensing and other powers to the Central drug regulatory authority and it may also have provisions which may harm […]

Cosmetics 160

Cosmetics Drugs Licensing Licensing 160

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 14, 2023

The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this […] (..)

Pharmacy 151

Pharmacy Licensing Licensing Regulation 151

XTalks

AUGUST 13, 2020

As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. Kaiser began Phase III trials of the vaccine at the end of July.

Vaccination 89

Vaccination Vaccine Trials Clinical Trials 89

Clinical Trial Podcast

JULY 18, 2020

Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. Developing a clinical trial budget can be a confusing exercise for sponsors and CROs.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing. •

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing.

Marketing 52

Marketing Research Clinical Trials Clinical Trials 52

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]

Pharma Companies 134

Pharma Companies Licensing Licensing Sales 134

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 23, 2023

With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.

Pharmacy 143

Pharmacy Sales Licensing Licensing 143

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 22, 2023

The point of contention, they pinpoint, is that if any retailer and manufacturer fails to display the license in a prominent place and is not conspicuous to the public, it amounts to violation of the […]

Drugs 143

Drugs Licensing Licensing Manufacturing 143

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 12, 2023

The Central Drugs Standard Control Organisation (CDSCO) has re-issued the list of fixed dose combinations (FDCs), declared as rational by the Prof Kokate Committee earlier and was released in February in connection with their new drug status and the procedure to be followed by the applicants when approaching the state licensing authority, with some (..)

Licensing 139

Licensing Licensing Drugs Clinical Trials 139

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

Worldwide Clinical Trials

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In trials, Casgevy was shown to help prevent episodes of debilitating pain, known as vaso-occlusive crises, that often plague patients affected by sickle cell disease.

Gene Editing 189

Gene Editing Gene Gene Therapy In-Vivo 189

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 6, 2022

The medical devices industry has urged the Centre to ensure obligation on the part of the buyer or users to purchase or use only those medical devices with required licenses and certifications under the New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, the draft of which has been circulated by the Union Health Ministry […].

Cosmetics 124

Cosmetics Licensing Licensing Drugs 124

XTalks

DECEMBER 1, 2020

Over the past several years, personalized medicine has led the charge in medical innovation, leading drug development efforts as well as furthering the research community’s understanding of human disease states. With this has come an increase in the size of the global clinical trials market, with an estimated worth of around $46.8

Clinical Trials 96

Clinical Trials Clinical Trials Trials Clinical Research 96

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. associates, residents, research fellows). based sites.

Licensing 52

Licensing Licensing Pharmacy Clinical Trials 52

Drug Discovery World

FEBRUARY 20, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. AstraZeneca’s Evusheld became the first antibody combination for pre-exposure prophylaxis (PrEP) against Covid-19 licensed in the UK. The candidate demonstrated 64.7%

Drug Trials 52

Drug Trials Trials Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 20, 2020

Patient dosing has begun in a Phase III clinical programme investigating GlaxoSmithKline’s 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, Bexsero and Menveo. Invasive Meningococcal Disease (IMD) is uncommon, with country-specific reported cases ranging from 0.1

Trials 52

Trials Vaccination Vaccine FDA Approval 52

XTalks

MAY 20, 2022

Do you possess laboratory skills, an analytical mindset and a penchant for research? If you enjoy working with biological samples and are enthusiastic about healthcare, a career as a clinical scientist might be just right for you. To start applying to clinical scientist jobs today, head over to the Xtalks Job Search platform.

Scientist 105

Scientist Life Science Clinical Research Doctors 105

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

Cloudbyz

JUNE 2, 2023

Electronic Data Capture (EDC) has revolutionized clinical research and pharmaceutical drug development. Direct costs include purchasing or licensing the EDC software, hardware acquisition (servers, devices), and system installation. Over the course of several trials, these cost savings can add up significantly.

Clinical Trials 73

Clinical Trials Clinical Trials Laboratory Information Management System Compliance 73

Drug Discovery World

SEPTEMBER 16, 2022

A biologic therapy for very young children with moderate to severe eczema (or atopic dermatitis) has been shown to be safe and effective in an international trial. The therapy is already licensed in the UK for adults and children aged six to 18, and was approved by the FDA in June 2022 for use in younger children.

Antibody 52

Antibody Licensing Licensing Trials 52

Delveinsight

JANUARY 21, 2021

Researchers at the Sanford Burnham Prebys Medical Discovery Institute and the University of Glasgow have early proof a combination strategy may work in AML. The researchers stated in the journal Nature Communications. TP53 is frequently mutated across various cancers, so targeting the gene is a popular pursuit in oncology research.

Research 52

Research Protein Clinical Trials Clinical Trials 52

Velocity Clinical Research

JUNE 27, 2023

The prolific researchers also had findings simultaneously published in the New England Journal of Medicine and The Lancet. Trial results were presented at the ADA sessions and published in NEJM. Novo Nordisk announced that a biologics license application for the insulin icodec has been submitted for FDA review.

Insulin 52

Insulin Trials Hormones Licensing 52

XTalks

MAY 28, 2024

XTALKS CLINICAL EDGE: Issue 2 — CSL Seqirus’ Interview Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52