Drug Target Review

DECEMBER 16, 2024

In this interview, she discusses her path to becoming a physician and clinical researcher, the obstacles she faced, and her dedication to improving outcomes for cancer patients. Dr Hingorani also shares insights into the strengths women bring to STEM, the importance of mentorship, and her vision for the future of oncology research.

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KIF1A

JULY 1, 2023

But drug R&D is an uncertain process, and many therapeutics get shelved during preclinical or clinical research, before they ever reach a patient. It requires a deep look at former products that ended at various stages of research and development.

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Drug Target Review

MARCH 4, 2025

Phenomix Sciences, built on over a decade of clinical research at the Mayo Clinic, is disrupting this outdated approach. The research demonstrated that obesity is not one disease, but many; each of which should be treated with different interventions, says Bagnall.

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Vial

MAY 22, 2024

Introduction Veeva Systems and Vial CRO ( contract research organization ) represent stakeholders in the clinical research landscape, which play integral roles in the successful execution of clinical trials. To learn more about Vial CRO, contact us today!

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

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Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. As von Itzstein et al.

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Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.

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Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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The Pharma Data

SEPTEMBER 15, 2020

During her medical practice, Seredina worked in clinical research as an investigator. The results of her research were published in a number of articles highlighting her knowledge of the critical challenges of clinical sites and of the importance of being patient-centric.

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Vial

JUNE 24, 2024

The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery.

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Vial

FEBRUARY 15, 2024

Clinical trials play a crucial role in advancing medical breakthroughs, but effective management is essential to unlock their full potential. Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. over the forecast period (2022-2030).

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Vial

FEBRUARY 26, 2024

The pharmaceutical and biotechnological landscape is constantly evolving and a key partner within the drug development process is contract research organizations (CROs) , who are at the forefront with sponsors to drive innovation in clinical research.

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Vial

MAY 8, 2024

As technological advancements drive the pharmaceutical industry forward, the shift towards digitalization, particularly with electronic data capture (EDC) systems, has become increasingly prominent. This article offers a comparative analysis of Vial and Medrio, two leading companies at the forefront of EDC innovation.

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Vial

MARCH 15, 2024

Nonetheless, while CROs play a pivotal role in streamlining operations and providing specialized expertise, sponsors continue to bear critical responsibilities throughout the clinical trial journey. Data quality and management : Managing and analyzing the huge volume of data produced in a clinical trial often proves challenging.

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Alta Sciences

SEPTEMBER 13, 2023

ELECTRICAL STIMULATION MODELS Using controlled electrical currents, or impulses, scientists can investigate the effects of pharmaceutical compounds on neural muscular or physiological systems. Some commonly used modes include the Barostat Model, the Staircase Challenge, and Skin Punch.

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Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding.

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Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. These services range from clinical study design and data management to statistical analysis and regulatory support.

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Vial

MARCH 25, 2024

Lastly, Vial’s experienced CRO executive team works closely with the expert site operations team to continuously review execution strategies, closely monitor patient recruitment efforts, and mitigate key study risks for all its clinical trials.

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Vial

DECEMBER 7, 2023

Although this staggering growth rate is related to the rise in adoption of cloud-based digital technology, as well as the need for more efficient drug discovery approaches, traditional methods continue to hold significant value in the pharmaceutical world.

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PPD

APRIL 30, 2024

Our PPD FSP regulatory affairs solutions teams, part of the PPD clinical research business of Thermo Fisher Scientific, regularly gather, assess and determine the impact of CTR intelligence. The EMA has reacted by simplifying some of the related processes (e.g.

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Agency IQ

FEBRUARY 21, 2024

As other health authorities started to require data standards, some, such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) decided to opt for CDISC for regulatory submissions. CMS in the United States ).

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Agency IQ

AUGUST 9, 2024

Additionally, representatives from trade groups and professional societies – like the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Psychiatric Association (EPA) – participated in several panels discussions alongside patient advocacy groups like the Psychedelic Participant Advocacy Network (PsyPAN).

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Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

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Agency IQ

FEBRUARY 2, 2024

The pharmaceutical trade association EFPIA has released its comments on the concept paper , however. Though public consultation on the concept paper ended exactly a year ago on January 31, 2023, the EMA has not released a summary of the comments it fielded during the year-plus public consultation period.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This article provides a comparative overview of Vial and IQVIA. increase on a reported basis and an 4.8%

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Vial

MAY 28, 2024

In the rapidly expanding world of digital health, Medable and Vial CRO (Contract Research Organization) , two leading technology organizations, are revolutionizing the way clinical research is conducted.

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Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). This acquisition has allowed the company to position itself as a global leader in clinical research services. launched a PV platform for clinical research registries.

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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PPD

JUNE 20, 2023

As some drug development organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. Does your CRO look after your most valuable resources?

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The Anticancer Fund

JUNE 7, 2022

Our intention is to help bring these findings to the attention of the broader cancer research community. Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context.

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The Pharma Data

NOVEMBER 5, 2020

Drawing upon 50 years of expertise in clinical research, biopharmaceuticals, biotechnology and drug discovery, Dr. Van Kampen excels as the chief executive officer of The Van Kampen Group, which assists other companies in research and liaisons with government and industry regarding licensing products for commercial use.

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Agency IQ

NOVEMBER 3, 2023

In simpler terms, these are live microbes that have actually demonstrated health benefits in clinical research. Keep in mind that this is the definition developed by ISAPP – there is no regulatory body confirming that any product on the market referred to as a “probiotic” has actually demonstrated benefits in clinical research.

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Drug Target Review

DECEMBER 13, 2024

Antibody-drug conjugates treatment of small cell lung cancer: advances in clinical research. Pharmaceuticals (Basel). MET alterations in advanced non-small cell lung cancer. Curr Probl Cancer. 2024;49:101075. Meng Y, Wang X, Yang J, Zhu M, Yu M, Li L, et al. Discov Oncol. 2024;15(1):327. J Clin Oncol. 2023;41(21):3747-61.

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Agency IQ

MARCH 1, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 5 Lawsuit (Vanda vs. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

FEBRUARY 2, 2024

Legal Deadline March 7 Considerations for the Development of CAR T Cell Products FDA CBER March 15 Patient Listening Session: Patients with ADHD FDA March 22 Patient Listening Session: Patients with ADHD FDA March 25 Deadline to participate in the Quality Management Maturity Program Pilot. and the E.C.

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Codon

APRIL 24, 2025

While China’s AI competitiveness may have blindsided the tech world, the pharmaceutical industry has already had quite a few “ DeepSeek Moments ” of its own. About one-fourth of all clinical trials and early drug development now happens in China. Just a couple of years ago, this number was about 10 percent.

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