Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

Clinical Trials 103

Clinical Trials Clinical Trials Trials Compliance 103

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

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 189

In-Vitro Licensing Licensing Regulation 189

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 187

Licensing Licensing Drugs Clinical Trials 187

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 189

Cosmetics Drugs Licensing Licensing 189

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 189

Pharmacy Licensing Licensing Regulation 189

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 188

Pharmacy Sales Licensing Licensing 188

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 188

Drugs Licensing Licensing Manufacturing 188

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 188

Licensing Licensing Drugs Clinical Trials 188

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

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 186

Pharma Companies Licensing Licensing Sales 186

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 181

Cosmetics Licensing Licensing Drugs 181

Cloudbyz

NOVEMBER 22, 2024

This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

XTalks

DECEMBER 1, 2020

As the research and medical community learns more about population variances in disease outcomes, whether as a result of regional genetic profiles, socioeconomic factors, or environmental inputs, it’s become necessary to ensure that clinical research trials include broad swaths of global participants.

Clinical Trials 96

Clinical Trials Clinical Trials Trials Clinical Research 96

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

pharmaphorum

JUNE 30, 2021

The US-based company was founded in 2019 and is on a mission to bring the practice of pharmacy into clinical research. He explores how COVID-19 has disrupted healthcare delivery and why virtual and decentralised trials could help increase patient access.

Pharmacy 52

Pharmacy Clinical Research Research Clinical Trials 52

XTalks

AUGUST 9, 2024

Whether you consider your program design to be virtual, remote or a hybrid of on-site and digital, decentralization of clinical research provides the opportunity to reach a more diverse patient population and reduce the burdens of time and travel associated with traditional research models.

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

Worldwide Clinical Trials

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. The post The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment appeared first on Worldwide Clinical Trials. In June 2023, the U.S.

Gene Editing 189

Gene Editing Gene Gene Therapy In-Vivo 189

WCG Clinical

JUNE 14, 2024

In this article, we will explore the significant value derived from conducting clinical trials sponsored by pharmaceutical companies for both physicians and hospital systems, with a specific focus on cancer care, and address potential counterarguments.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

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

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 Vaccine Vaccination 76

Rethinking Clinical Trials

JULY 6, 2023

The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. Learn more Read more about Decentralized Clinical Trials. DCTs can make things easier for patients and the research more efficient.

Trials 100

Trials Clinical Trials Clinical Trials Licensing 100

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

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

Antibody 98

Antibody Trials Licensing Licensing 98

pharmaphorum

JANUARY 27, 2021

AstraZeneca is playing catch up with Eli Lilly and Regeneron with its antibody therapy for COVID-19, but aims to narrow the gap with the help of decentralised clinical trial specialist Care Access Research. The two antibodies were discovered by Vanderbilt University Medical Center and licensed to AZ in June 2020.

Antibody 94

Antibody Clinical Trials Clinical Trials Trials 94

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.

Vaccine 89

Vaccine Vaccination Trials Clinical Trials 89

XTalks

AUGUST 2, 2024

The ARCADIA trials reinforce nemolizumab’s potential as a transformative treatment for atopic dermatitis, offering new hope to patients seeking relief from this burdensome condition. The US Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for review, with a decision expected by the end of this year.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Licensing 52

Velocity Clinical Research

AUGUST 8, 2024

Before that, he’d spent 36 years in primary care, treating patients skewed toward the age group most at risk of Alzheimer’s, and it was this experience that, in part, encouraged him to cross over into clinical research. “It The importance of clinical trials That hope is a motivator for many clinical trial participants.

Clinical Trials 105

Clinical Trials Clinical Trials Genetics Clinical Research 105

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. However, adopting this system requires a significant financial commitment.

Clinical Trials 94

Clinical Trials Clinical Trials Laboratory Information Management System Compliance 94

Worldwide Clinical Trials

MAY 31, 2022

I was lost in my head thinking about how he may never get his driver’s license, attend his high school prom, or even graduate from kindergarten. Considering Clinical Trials. When it became clear that Kai’s chemo plan was not helping, we turned to clinical trials.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Doctors 130

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

Cloudbyz

AUGUST 2, 2022

PMRs/PMCs are studies or clinical trials that are conducted by the applicant after the Food and Drug Administration (FDA) has approved or licensed a product for marketing. These studies or clinical trials can be required either by regulation or statute (PMR), or by a written agreement, between FDA and the applicant (PMC). .

Marketing 97

Marketing Research Trials Clinical Trials 97

XTalks

DECEMBER 13, 2024

The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Blenrep in combinations with BVd and pomalidomide plus dexamethasone (BPd), with a decision expected by July 2025. A day before GSKs announcement, Johnson & Johnson also released two promising clinical trial results.

Antibody 99

Antibody In-Vivo Trials In-Vitro 99

pharmaphorum

AUGUST 27, 2020

The common challenge is undertaking lengthy and capital-intensive phase II/III clinical trials. For example, if a company is carrying out clinical trials, then a clinical research organisation is needed to run them. Companies have struggled to access intermediate capital.

Vaccine 122

Vaccine Vaccination Life Science Clinical Trials 122

pharmaphorum

MARCH 25, 2022

While these NPDT products do not require FDA clearance, they must substantiate their claims with rigorous, clinical research. These products require clinical trials to demonstrate their safety and efficacy before they can be prescribed by a licensed healthcare professional.

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Production Regulation Research Clinical Research 115