The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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ACRP blog

JANUARY 26, 2023

Clinical trial sites that offer their study volunteers travel-related reimbursement and services, translated documents and translator services, and adequate compensation can have the most impact in terms of achieving diverse enrollment of participants, according to a new survey by a quartet of clinical researchers.

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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. Below are examples of key items auditors/inspectors look for during an audit.

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ACRP blog

SEPTEMBER 12, 2024

ACRP member Tony Succar, PhD, MScMed, Assistant Professor in the Mann School of Pharmacy and Pharmaceutical Science, Department of Regulatory and Quality Sciences, University of Southern California (USC). New for the 2024–2025 academic year, USC offers an MS in Clinical Trial Management which is coordinated through Succar’s department.

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XTalks

JANUARY 8, 2024

The FDA’s endorsement stems from results obtained from the company’s Phase III NefIgArd clinical trial. Related: Filspari (Sparsentan) Rare Kidney Disease Drug Gets FDA Approval Availability and Price of Tarpeyo Tarpeyo is available solely through Biologics by McKesson, Calliditas’ specialty pharmacy.

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ACRP blog

JANUARY 25, 2024

“Decentralized clinical trials (DCTs) were critical in enabling clinical research activities during the pandemic,” notes Adam Samson, MS, PMP, CCRA, CCRC, CCDM, Head of Clinical Delivery Operations, Real-World Evidence Clinical Trials, at Walgreens. Continued progress in modernizing clinical trials is essential,” he adds.

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Druggist

JANUARY 15, 2021

200mg ibuprofen is widely available in shops and pharmacies for self-selection by customers. 400mg ibuprofen, on the other hand, is a pharmacy-only medication (P), which means it can only be purchased from registered pharmacies. . Many combinations of products are available in pharmacies. Ibuprofen: brands and products.

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pharmaphorum

DECEMBER 7, 2022

Based in Cornwall for now, instead of a face-to-face visit the digital check will include patients undergoing an online questionnaire, as well as being given a kit for taking a blood sample at home, and blood pressure checks will take place at either a local pharmacy or in the GP waiting room.

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XTalks

FEBRUARY 3, 2021

The new vaccine technology (mRNA) has been in research since 2005, but in trials on cancer cells. These vaccine productions had gone through the regular steps starting with three clinical trials, publishing the trial results then manufacturing the vaccine. The vaccines have moved through all preclinical and clinical phases.”.

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WCG Clinical

MARCH 17, 2023

But why is the coverage analysis process so vital for clinical trials and how can research sites do it more effectively? If most items cannot be billed to insurance and there are no funds to cover those costs, then it’s time to make a decision about the financial feasibility of conducting the trial.

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Advarra

SEPTEMBER 7, 2023

This includes the IRB or EC, sponsored research, and the clinical trials office – when a COI is identified, HRPP staff can collaborate to determine appropriate management. Typically, this is the office of sponsored programs or a clinical trials office. HRPPs vary widely in structure, size, and component programs and offices.

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Druggist

OCTOBER 21, 2020

The main products used for toenail fungus treatment are available in most pharmacies, supermarkets and perhaps with the best range of products found online. Amorolfine 5% nail lacquer (brand name: Curanail 5% w/v Medicated Nail Lacquer) is available as general-sale medication, which can be purchased in most supermarkets and pharmacies.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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Rethinking Clinical Trials

MARCH 6, 2024

Schell Professor of Management and Applied Economics MIT Sloan School of Management Slides Keywords Food-as-Medicine, Randomized Clinical Trial, Diabetes Key Points Diabetes is common and costly. Clinic staff included a dietitian, a nurse and a community health worker. The trial was for adults with HbA1c greater than 8.0,

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pharmaphorum

MAY 20, 2022

In recent years the retail pharmacy chain has begun to delve more and more deeply into the healthcare sector – by constantly expanding the basic healthcare services offered at their instore Minute Clinics, and by buying into the health insurance insurance space with their $69 billion purchase of Aetna in 2017.

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Bioengineer

JULY 23, 2021

MUSC Hollings Cancer Center part of promising clinical trial for aggressive lymphoma. MUSC Hollings Cancer Center was one of 28 clinical sites around the world that participated in the LOTIS-2 trial to test the efficacy of Loncastuximab tesirine, a promising new treatment for aggressive B-cell lymphoma. sponsored the trial.

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pharmaphorum

FEBRUARY 10, 2022

CVS Health has said it will beef up its clinical trials operations, improving its ability to recruit patients from a broad demographic spectrum, via an agreement with digital health company Medable. Pharmaceutical industry organisation PhRMA says that most delays to trials occur in the start-up phase.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

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Pharma Marketing Network

JUNE 10, 2020

Most recently, telemedicine and specialty pharmacy connected together to create a product that a consumer can get directly. You go online, you talk to a doctor via telemedicine, and a specialty pharmacy then delivers it for you. or change the way I do clinical trials or change the way I actually do clinical recruitment?

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Intouch Solutions

AUGUST 5, 2021

It, like the Nightingale Pledge for nurses, is a list of tenets that physicians abide by to uphold certain morals and to ensure healthcare professionals (HCPs) provide top-quality care to all who seek it. “I Clinical Trials Beyond medical procedures, clinical trials are a space that transgender people are often left out of.

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The Pharma Data

JANUARY 12, 2021

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. .”

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Pharma Marketing Network

JUNE 10, 2020

Most recently, telemedicine and specialty pharmacy connected together to create a product that a consumer can get directly. You go online, you talk to a doctor via telemedicine, and a specialty pharmacy then delivers it for you. or change the way I do clinical trials or change the way I actually do clinical recruitment?

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pharmaphorum

AUGUST 1, 2022

That clinic is a simple building with, if you’re lucky, one or two nurses that may not offer the services that you need,” Kroezen says. And that’s why we have seen in some of the clinical trials that we have done, that it really brings strong improvements to the maternal and child health outcomes,” Kroezen says.

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The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

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The Pharma Data

NOVEMBER 18, 2020

“Tampa General Hospital and USF Health were already actively conducting clinical trials on COVID-19 and had the team, location and infrastructure in place to identify and care for the patients who can benefit most from this treatment.”

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The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Data from these trials will be used to support a future BLA submission.

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ACRP blog

JANUARY 10, 2024

Views from ACRP Members Topics highlighted include diversity and inclusion, decentralized clinical trial (DCT) elements, workforce challenges, and a possible role for sponsors and contract research organizations (CROs) in supporting outreach by sites based in diverse communities.

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Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs.

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Rethinking Clinical Trials

SEPTEMBER 22, 2022

Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. DANFLU-1, Pragmatic Clinical Trials. The DECODE trial used registry data to identify patients with chronic kidney disease. For most trials it’s 2-4%. Key Points.

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Pharma Marketing Network

JUNE 8, 2020

So for example, you think about the doctors and nurses that you know, are they getting paid far more than they were, you know, five ten twenty years ago now, I mean, maybe it’s growing at the rate of inflation and there’s really two markets now particularly because of high deductible plans and the high prices in healthcare.

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The Pharma Data

DECEMBER 31, 2020

Right now, most shots are being given at hospitals, clinics and nursing homes, but Perna and Slaoui agreed that the pace of vaccination should pick up considerably once doses are given out by the major pharmacy chains. Another COVID-19 vaccine enters final trials. A global scourge. By Thursday, the U.S.

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XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. As of July, the company and its federal partner stated that it is on track to supply between 500 million to 1 billion doses a year at a dose of 100 µg now selected for their Phase III trial.

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The Pharma Data

JANUARY 13, 2021

Right now, the vaccines are largely being distributed to people in the highest-risk categories, including frontline health care workers and older people and staff in nursing homes. More community centers and pharmacies will also be added to the list of places where people can be vaccinated, the Times reported.

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