Rethinking Clinical Trials

DECEMBER 12, 2023

Investigators from the NIH Pragmatic Trials Collaboratory in 2023 shared study results, generated new knowledge, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials.

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Rethinking Clinical Trials

DECEMBER 18, 2023

The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regulatory Core , NIH staff, and NIH Collaboratory Coordinating Center personnel. Both projects are in their planning phase.

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VirTrial

AUGUST 21, 2021

Telemedicine or telehealth solutions may not be new, but virtual video visits are becoming more common for communication between patients and healthcare providers thanks to COVID-19. In addition, these video conferencing tools rarely mention research sites or have any features designed to simplify the workflows for this important stakeholder.

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Drug Channels

MAY 24, 2023

The Federal Trade Commission (FTC) has recently started investigating these GPOs. I wonder if this additional focus will deepen the FTC’s ongoing investigation —or slow it down even further? I also highlight a sixth, alleged rationale that is currently the subject of litigation. to 1:30 p.m.

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Clinical Trial Gurus

AUGUST 8, 2021

Starting a clinical research investigative site requires various forms of insurance coverage. In this video we discuss a few different forms of liability coverage that site owners can purchase.

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Clinical Trial Gurus

SEPTEMBER 26, 2021

Investigational Product Accountability is an activity that every clinical research associate has to make when it comes to interim monitoring visits. In this video I discuss 5 key components of this critical function.

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Clinical Trial Gurus

SEPTEMBER 30, 2021

The long tail of clinical research opportunities for investigative sites and contract research organizations are endless. In this video I interview the co founder of Zymewire, a leading business development tool in the industry.

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Clinical Trial Gurus

SEPTEMBER 1, 2021

What are essential documents as they pertain to Investigational Site Files in clinical research? In this video I break it down to its most basic components and you will learn all about regulatory document maintenance.

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Clinical Trial Gurus

JUNE 23, 2021

There would be no clinical studies without physicians (Principal Investigators). In this video, I discuss all of my experiences over the past decade and a half as they pertain to working with principal investigators on a number of levels: from clinical research coordinator, clinical research assistant, site owner, and consultant.

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Velocity Clinical Research

JANUARY 19, 2024

Enhanced site enrollment forecasting to minimize overages, alongside reduced investigational product distribution and storage needs. Learn more about environmental sustainability at Velocity > The post Video: Environmental Governance appeared first on Velocity Clinical Research. How can Velocity deliver more efficient trials?

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Clinical Trial Gurus

AUGUST 9, 2021

Investigator Site Files, otherwise known as regulatory binders, house the majority of the regulatory documents at the site level. In this video, I discuss some common issues at the clinical research site level as it pertains to filing, maintaining, and completing regulatory forms.

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Clinical Trial Gurus

AUGUST 3, 2021

In this episode of my videos, I interview one of my newest team members and Principal Investigator, Dr. Marco Zahedi. We have a candid conversation about why he is conducting clinical research, what the pragmatic aspects of life as a PI are like, and much more!

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Rethinking Clinical Trials

JULY 26, 2022

At this year’s annual meeting of the NIH Pragmatic Trials Collaboratory Steering Committee, we interviewed investigators from 3 Demonstration Projects in different phases of the trial life cycle. Learn more about these innovative Demonstration Projects in the brief video updates below. Learn more about IMPACt-LBP. ?.

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pharmaphorum

MARCH 25, 2022

There was a fairly high rate of false positives in the study, which could lead to unwarranted patient anxiety and lead to unnecessary clinic visits and tests, said the investigators, although that needs to be balanced against the benefits of catching some cases of AFib early.

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Velocity Clinical Research

JULY 27, 2023

Serving as the lead investigator for Novo Nordisk’s ONWARDS 1 program, Dr. Rosenstock has made remarkable strides in exploring what could be the world’s first once-weekly basal insulin. “In Julio Rosenstock, MD, has his work spotlighted as the feature article on the New England Journal of Medicine’s homepage.

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Rethinking Clinical Trials

OCTOBER 10, 2023

The consultations took place by video conference and included representation from the studies’ principal investigators, members of the NIH Collaboratory’s Ethics and Regulatory Core , NIH staff, and NIH Collaboratory Coordinating Center personnel.

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Velocity Clinical Research

FEBRUARY 9, 2024

About half of Principal Investigators (PIs) conduct only a single study in their career. Velocity developed the innovative Principal Investigator Onboarding and Training (PIVOT) Program to address the pressing issue of “one-and-done” PIs in clinical research.

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Clinical Trial Gurus

JUNE 9, 2021

Investigator Site Files, otherwise knows as regulatory binders, make up an important part of a clinical research coordinator’s tasks. In this video, I discuss with The CRC Academy instructor, Monica Cuitiva on how she handles this component of her job responsibility on a practical level.

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Rethinking Clinical Trials

JULY 18, 2023

DeBar is a principal investigator of the BackInAction and PPACT Demonstration Projects, and Morone is the principal investigator of the OPTIMUM Demonstration Project. Lay summaries, videos, and graphics can help complicated research results be more accessible. They described sharing results as important now more than ever.

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Rethinking Clinical Trials

JUNE 29, 2022

In a recent video interview , lead author Dr. Emily O’Brien praised the study teams. “We The NIH Collaboratory published a tool last year to assist investigators in identifying impacts of the COVID-19 pandemic on ongoing pragmatic trials. All of the Demonstration Projects were able to adapt to pandemic-related changes.

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pharmaphorum

DECEMBER 7, 2022

Elon Musk’s brain computer interface (BCI) company Neuralink is being investigated by law enforcement authorities in the US amid allegations of animal welfare violations in its testing facilities. Reuters said it has interviewed 20 current and former Neuralink employees in its investigation, as well as reviewing internal company documents.

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ECRG Media's Clinical Research Podcast

FEBRUARY 17, 2022

Tips for Principal Investigators During Monitoring Visits Don't forget to Subscribe for new content! Send in a voice message: [link] Tips for Principal Investigators During Monitoring Visits Don't forget to Subscribe for new content! Reach out by comment or email if we can help in any way.

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ECRG Media's Clinical Research Podcast

FEBRUARY 17, 2022

Tips for Principal Investigators During Monitoring Visits Don't forget to Subscribe for new content! Send in a voice message: [link] Tips for Principal Investigators During Monitoring Visits Don't forget to Subscribe for new content! Reach out by comment or email if we can help in any way.

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WCG Clinical

AUGUST 1, 2023

The sponsor needed to expedite training to meet critical site activation milestones, provide consistent and accessible training tools for investigators, and position sites to focus on enrollment and retention. The sponsor’s current internal system used for training sites was cumbersome and lacked intuitive functions.

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Pharmaceutical Technology

JULY 15, 2022

Nothing epitomises market failures more than the cost of insulin,” Newsom said in a video posted on Twitter. However, a January 2021 bipartisan US Senate Finance Committee investigation into insulin pricing found that insulin manufacturers and PBMs are jointly responsible for high insulin prices.

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WCG Clinical

MARCH 30, 2023

The live-action animation thoroughly detailed the injection technique process by showing different needle angles, effectively training the investigators on the precise angles. All training videos and related resources are converted into site quick guides and accessible through the InvestigatorSpace platform.

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FDA Law Blog

MARCH 4, 2022

While it’s not mind-blowing that OPDP would find a series of videos while scrolling Instagram (particularly when it’s flagged by FDA’s Bad Ad program), OPDP issued a Warning Letter on February 11 concerning a little-seen interview with the former CEO of CytoDyn discussing its investigational new drug product, leronlimab.

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Advarra

DECEMBER 14, 2023

Sites working with an investigational new drug (IND) are often subject to an FDA site inspection. b)) Categorized within the investigational plan regulations, there is a specific emphasis on accurate and complete documentation of all trial activities. What are Site Inspection Findings? Inadequate and Inaccurate Records (21 CFR 312.62(b))

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Drug Discovery World

APRIL 18, 2023

AVA3996 is in pre-clinical development with the aim of submitting an Investigational New Drug (IND) application to allow clinical development to begin during 2024.

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VirTrial

OCTOBER 14, 2020

BlueCloud® by HealthCarePoint (HCP) and VirTrial today announced a global collaboration that will enable international investigator sites to become VirTrial technology competent and ready for the benefit of Sponsors, CROs, Universities, regulatory agencies and other industry stakeholders, and ultimately patients. About VirTrial.

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FDA Law Blog

MAY 4, 2023

A DCT is a clinical trial where some or all of the trial-related activities, such as administration of the investigational product, data collection, or safety monitoring, occur at locations other than traditional clinical trial sites. The informed consent process should inform participants whom they should contact with questions.

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ACRP blog

SEPTEMBER 11, 2023

[i] , [ii] Despite the challenges, the pandemic presented an opportunity to test the strength of deploying fully remote clinical trials from beginning to end, relying solely on innovative digital health technologies (DHTs) like real-time video conferencing, electronic data capture, eConsent, and eCOA (electronic clinical outcome assessments).

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XTalks

MAY 15, 2023

In 2019, an animal rights group released an undercover video showing workers at one of Fairlife’s milk suppliers, Fair Oaks Farms, abusing calves. The video went viral, leading to protests and boycotts of Fairlife products. The company also launched an investigation into the matter.

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Pharma Marketing Network

FEBRUARY 4, 2021

The Pharma Marketing Network’s latest webinar, Video, Voice, and Virtual: Applying New Digital Technology to Enhance Customer Experience, shared unique perspectives from a diverse group of panelists, offering insights into the customer experience during 2020 – a year defined by unexpected challenges.

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pharmaphorum

AUGUST 22, 2021

” RAS devices – which enable surgeons to use computer software and mechanical arms to carry out procedures whilst viewing the site on video – have been cleared for use in some types of surgery commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy.

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The Pharma Data

JANUARY 14, 2021

WHO Experts Finally Arrive in Wuhan for COVID-19 Investigation. China will “support and offer convenience for the WHO experts’ joint international investigation” in the country, Chinese Foreign Ministry spokesman Zhao Lijian told reporters. Professional. THURSDAY, Jan. CBS News Article. © 2021 HealthDay.

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XTalks

MAY 18, 2023

In an outbreak that the CDC investigated last year, four babies were sickened, including two who died. Despite an undercover video showing workers at one of Fairlife’s milk suppliers abusing calves and subsequent lawsuits, Fairlife milk has been dominating the milk category, earning over $1 billion in annual retail sales in 2022.

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