Vial

FEBRUARY 23, 2024

In 2022, the global market value of patient portals within the clinical research and healthcare industries was estimated to be US $2.9 In 2008, prior to ARRA and the HITECH Act, only 10% of hospitals in the United States had transitioned from paper-based methods into EMRs, primarily due to their exorbitant set-up costs.

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Drug Discovery World

APRIL 14, 2023

Kathryn E Wellen, PhD – Outstanding Achievement in Basic Cancer Research Wellen is an investigator at the Penn Epigenetics Institute and Vice Chair and Professor in the Department of Cancer Biology in the Perelman School of Medicine at the University of Pennsylvania. Vickers’ award lecture will be held on Sunday April 16 at 3pm ET.

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Drug Discovery World

SEPTEMBER 28, 2022

AI-based diagnostic software and clinical trials technology proved to be two of the most attractive health investments, alongside mental health and wellness and medical imaging companies. . There, it is combined with algorithms generated by other hospitals in an identical way to create an optimised algorithm.

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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.

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Licensing Licensing Pharmacy FDA 52

The Premier Consulting Blog

NOVEMBER 20, 2023

Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. This change is driven by the intent to consistently regulate all producers of such devices. Expanded Definition: FDA aims to reshape the boundaries of IVDs within 21 CFR Part 809.3.

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Laboratories FDA Clinical Development Regulations 52

The Pharma Data

DECEMBER 27, 2020

“The approval of orelabrutinib would not have been possible without the strong support from our partners, physicians, experts and patients who participated in a series of clinical trials,” said Dr. Cui. Data from trials with orelabrutinib have shown sustained efficacy in the treatment of R/R MCL patients,” said Jun Zhu, M.D.,

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

NOVEMBER 10, 2020

This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. NEW YORK and LONDON, Nov. NEW YORK and LONDON, Nov. and Europe. Dr. Howard L.

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PPD

AUGUST 5, 2024

Composite endpoints might include factors such as hospitalization, transplantation and worsening of clinical outcomes. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

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Clinical Trials Trials Clinical Research Disease 98

The Pharma Data

DECEMBER 15, 2020

The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. STOCKHOLM , Dec.

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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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NIH Director's Blog: Drug Development

JULY 20, 2017

The first genetic mutation that causes CF was discovered by a collaborative effort between my own research lab at the University of Michigan, Ann Arbor, and colleagues at the Hospital for Sick Children in Toronto—more than 25 years ago [1]. Credit: Zhang & Chen, 2016, Cell 167, 1586–1597.

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Drug Discovery World

JULY 1, 2024

million) over a five-year period for Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity (the PRE-STORK Trial). million) was awarded over a five-year period for the Pre-pregnancy Weight Loss and Reducing Childhood Overweight project (PREPARE CHILD), a randomised controlled trial. million ($3.4 million ($3.4

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The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. Corey Davis Ph.D., LifeSci Advisors LLC cdavis@lifesciadvisors.com. Follow NervGen on Twitter (@NervgenC) and LinkedIn (NervGen Pharma Corp.)

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The Pharma Data

JANUARY 13, 2021

patients hospitalized with COVID-19. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 people. Patient Population: 45 hospitalized patients with COVID-19. The clinical status of all patients will be evaluated daily until discharge and at Day 29 and Day 60.

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Hospitals Clinical Trials Therapies Treatment 52

The Pharma Data

NOVEMBER 10, 2020

As the new coronavirus continues raging through the global, however, many hopeful treatments for COVID-19, such as Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens have been proven by WHO SOLIDARITY to have little or no effect on hospitalized COVID-19 patients. SHANGHAI , Nov. The paper has been contributed and under review.

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The Pharma Data

JANUARY 10, 2021

SH ) submitted its pivotal phase III clinical trial application (IND) of national class I innovative drug Chiauranib to NMPA, for the treatment of Small Cell Lung Cancer (SCLC) as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards. SHENZHEN, China , Jan.

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The Pharma Data

JULY 21, 2021

Support the establishment of Digitally Enabled Clinical Trial Centers of Excellence, managed and led by clinical researchers of color, to build trust, increase diversity and inclusivity in clinical trials, and contribute to improved health outcomes for people of color. of the US population but only 6.2%

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Medical Schools Clinical Trials Trials Science 52

Agency IQ

SEPTEMBER 1, 2023

In medical product research, RWD is considered any data captured outside of the confines of a clinical trial, such as claims or electronic health record (EHR) data or records from clinical registries, while RWE is evidence generated from analyzing those data.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Sharp Memorial Hospital , 264 Cal. Sharp Memorial Hospital, Inc. , A Florida trial court, in Brookes v. at 77 (citation omitted). In United States v. Brown , 348 F.3d 3d 1200 (10th Cir. 673, 676 (Cal.

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