May, 2020

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What to Expect from the FDA During COVID-19 Product Development

Camargo

As the COVID-19 national emergency stretches on in the United States, the eyes of the. The post What to Expect from the FDA During COVID-19 Product Development appeared first on Camargo.

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It’s OK to Not Be OK

Find Me Cure

A chronic illness diagnosis can turn your world upside down. Especially an illness that can significantly limit your ability to do the things you love and be present with the people who matter to you. People with Myasthenia gravis have shared a lot of stories of missed friend birthdays, graduations, weddings… Here on the FindMeCure blog, we have always encouraged you to reach out and admit you’re struggling.

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Even Drugs Manufactured in America are not “Made in the USA”

Pharmacy Checkers

PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. are foreign made , a number far higher than the 40% figure regurgitated by the FDA year after year. Americans care a lot about this issue.

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The Clinical Study Protocol: The Basics

Cloudbyz

If you are new to the clinical research industry, it’s important to know how clinical studies are developed and run. The basis for all such studies is the study protocol, about which this piece will provide a high-level overview. A study protocol is a document that provides an overview of the study. It includes information such as design, objectives, and methodology, and guides research conduct during the study.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Clinical Trial Day: Celebrating 273 Years of Medical Advancements

My Local Study

When you hear ‘clinical trials,’ today you think about research sites, hospitals, and doctor’s offices. What you absolutely don’t think about is a British Royal Navy fleet ship ridden with scurvy, but that’s how clinical trials started! On this day, 273 years ago, surgeon mate James Lind conducted a clinical trial to advance medicine for. Read more Clinical Trial Day: Celebrating 273 Years of Medical Advancements.

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Adapting Clinical Trial Protocol in Response to COVID-19

VirTrial

Based on recent SCRS survey data , a vast majority of research sites (58%) anticipate that COVID-19 will negatively affect their clinical trial enrollment and nearly half of respondents (47%) feel COVID-19 will have a negative effect on retention. With the number of new cases increasing daily, these expectations are, unfortunately, likely to be correct. .

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Living with a Chronic Illness During a Health Pandemic

Find Me Cure

Morgan from Is Was Will Be is one of those people who persevere despite the difficulties and no chronic illness can stop them from living their life to the fullest. On her blog, you’ll find all about the spoonie life, mental health and natural living so you can know you’re not alone on your journey. Today Morgan shares with FindMeCure what life is like with a chronic illness during a pandemic and how to preserve your sanity in these trying times.

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Gilead says remdesivir is not sold online and they are correct

Pharmacy Checkers

A good portion of this blog takes on Big Pharma for their funding of misleading public information campaigns and programs against drug importation and the practice of safe international online pharmacies. Much of their messaging tries to convey that you can’t find their medications online at lower cost from other countries safely. Because of the work we do, we know for a fact that claim is ridiculous and independent research backs that up entirely.

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The Mental Health Consequences of COVID-19 and Physical Distancing

JAMA Internal Medicine

This Viewpoint emphasizes the importance of mitigating the mental health consequences of social distancing in the COVID-19 era.

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The OK for Patients’ Return to Healthcare Needs Clear Signals From Trusted Sources

Eye on FDA

COVID-19 was a shock to the system unlike anything that had been anticipated. Even prior to the shutdown, health-perceptive people were starting to avoid public venues and there were declines in the numbers of people going out to eat at restaurants, to public functions, visiting with friends and also going to the doctor’s offices. When it comes to healthcare, that has translated into multiple stress points to our system of care spanning both health and economics with people avoiding care f

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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PwC Pharma & Life Sciences Webinar: COVID-19 impact on the ITX and regulatory DNA

Pharma Business Blog

Dear pharma & life sciences colleagues, It was a pleasure to welcome you to our webinar: PwC Pharma & Life Sciences Webinar: COVID-19 impact on the ITX and regulatory DNA. Attached below you can download the presentation. Should you have any questions, please get in touch with us, we are happy to discuss them with you. We look forward to meeting you again soon.

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Choosing the Right Animal Model for COVID-19 Nonclinical Research

Camargo

Research into drugs and vaccines to combat the ongoing COVID-19 pandemic caused by the SARS-CoV-2. The post Choosing the Right Animal Model for COVID-19 Nonclinical Research appeared first on Camargo.

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To Life, Liberty and The Pursuit of Happiness

Pharma Packaging Solutions

We hope this message finds you and your family well. We have thought about you so much during these unique times. Our associates have been working around the clock to meet unprecedented demand due to COVID-19. Please know that our associates, with creativity and agility, are navigating this new normal and collaborating more than ever with customers to set a new standard of care and support.

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Potential Importance of Personal Importation Will Rise as Tens of Millions Lose Health Insurance

Pharmacy Checkers

Americans without health insurance are four times more likely to buy a prescription drug from another country due to cost. That’s from an analysis by the U.S. Centers for Disease Control and Prevention, National Center for Health Statistics , published in 2015. Not surprisingly, more comprehensive health insurance generally leads to greater prescription adherence, meaning people properly taking prescription medication.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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COVID-19 Clinical Trial Updates

My Local Study

COVID-19 remains on the tip of everyone’s tongue, and with each state varying it’s reopening stances and policies, many wonder about vaccines and treatment options. But vaccines and treatments don’t just “appear” one day and are available for everyone. They go through a clinical trial process to determine a vaccine or treatment’s safety and effectiveness.

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Drug Channels News Roundup, May 2020: COVID-19 and Formularies, Retail-to-Mail Trends, ABC on Biosimilars, and Social Distancing the CVS Way

Drug Channels

FWIW: Summer is finally here. Before you venture outside for your lockdown barbeque, check out these noteworthy items off the Drug Channels grill: Payers predict how COVID-19 will affect formularies Our analysis of the 2020 retail-to-mail shift AmerisourceBergen profiles biosimilars Plus, CVS pharmacy offers a clever way to measure appropriate social distancing.

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Crucial Data Solutions Forms Partnership with Durham Tech to Support Clinical Research Education

Crucial Data Soutions

Durham Tech’s clinical trials program utilizes TrialKit, a data collection and study management platform from Crucial Data Solutions. Left to right: Dr. William Gluck, Program Director; Jeff Rogers, CDS President; Bill Ingram, Durham Tech President. RENO, Nev.–(BUSINESS WIRE)–Crucial Data Solutions, Inc. (CDS), a provider of innovative software to advance clinical research, and Durham Technical Community College, an academic institution in North Carolina, announced today they have fo

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Blending the Power of CTMS with IBM Merge

Cloudbyz

Clinical Trials, slowly but surely are becoming the new talking point of our generation. Even the teenagers of this contemporary age were discussing and searching about the clinical trials over the internet. Many of the world’s powerful bureaucracies are closely monitoring the curiosity spinning around clinical trials. What’s the basis for such significance?

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Is It Time To Start Traveling Again? Covid Update

ECRG Media's Clinical Research Podcast

Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Send in a voice message: [link] Don't forget to Subs

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Update on COVID-19

Pharma Packaging Solutions

As the situation with COVID-19 continues to change, we wanted to let you know that Carton Service/Pharma Packaging Solutions is defined as an Essential Industry due to the life-sustaining products we produce. Even with communities establishing Shelter-In-Place or Safer-At-Home orders, our associates have been notified that they are essential workers.

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Today’s Forecast: 5 Predictions About the Future of Clinical Trials

Imperical Blog

There is a popular saying: “It’s difficult to make predictions, especially about the future.” Correct, but that didn’t stop me from asking Imperial leadership for their thoughts on what we might see in the years to come. Balancing innovation and risk. The COVID-19 pandemic has created a phenomenon impacting both personal and professional lives — “COVID Time.

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Why Do CVS And Express Scripts Rely on Secretive Private Companies to Run Their Copay Maximizer Programs?

Drug Channels

In Copay Maximizers Are Displacing Accumulators—But CMS Ignores How Payers Leverage Patient Support , I explained a new Centers for Medicare and Medicaid Services (CMS) final rule regarding health plans’ use of copay accumulator adjustment. I also highlighted why plans have responded to the negative patient impact from accumulators with copay maximizer programs.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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PwC Pharma & Life Sciences Webinar: COVID-19 impact on the ITX and regulatory DNA – Thursday 28. May 2020, 10:30 CEST

Pharma Business Blog

As the COVID-19 situation develops, tax and regulatory specialists within the pharmaceutical & life sciences industry are increasingly facing complex challenges. Efficient and pragmatic solutions have to be realised, with fewer resources, in line with the changing local legislation. The exchange of information is the best practice in this industry to support and inspire you in your daily business.

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Clinical Trial Budget & Payment Management Solution Overview

Cloudbyz

[link]. Cloudbyz Budget management solution is an integrated end-to-end solution that enables all the stakeholders, ie Sponsors, CRO’s and Sites to gain visibility, control and flexibility in managing the financials across clinical trial projects. The solution helps in accelerating study budget management with a high level of accuracy and minimal manual effort.

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Is It Time To Start Traveling Again? Covid Update

ECRG Media's Clinical Research Podcast

Don't forget to Subscribe for new content! Subscribe: [link]. Call or Text: 910-502-3732 Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.

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Team Spotlight with Kalea Belso

Client Pharma

Kalea Belso is Client-Pharma’s Commercial Finance Manager, she is a great team member and always arrives with a smile on her face – even in our video team catch up’s. We took a moment to find out a little more about Kalea and get an insight into her role with Client-Pharma. What is your main day-to-day role? My role is extremely varied, but my main responsibility is to oversee the Client-Pharma finance department working closely with the CEO and other senior management helping out with various a

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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Safety Precautions for Laboratory Research With COVID-19 Specimens

Forte Research Systems®

Biosafety has surged to the spotlight due to the current COVID-19 global pandemic, motivating sites to conduct a risk assessment and develop a risk mitigation plan.

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Copay Maximizers Are Displacing Accumulators—But CMS Ignores How Payers Leverage Patient Support

Drug Channels

COVID-19 has not stopped the wheels of policy bureaucracy from grinding. Last week, the Centers for Medicare and Medicaid Services (CMS) released its final Notice of Benefit and Payment Parameters for the 2021 benefit year. You’ll find the document links below. This final rule permits insurers to exclude the value of a pharmaceutical manufacturer’s copay support program from a patient’s annual deductible and out-of-pocket maximum obligations.

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OFAC fined US subsidiary of Austrian ERBER Group after misinterpreting US Sanctions

Pharma Business Blog

Animal nutrition company BIOMIN America was fined by more than $250’000 for coordinating sales of agricultural commodities to a company in Cuba without authorization from OFAC (US Office of Foreign Assets Controls). Instead of applying for the necessary OFAC authorizations for exports to Cuba, BIOMIN America developed a transaction structure involving their owned or controlled foreign entities.

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Enabling Your Remote Workforce

Cloudbyz

To Better Service Your Customer During the COVID-19 Pandemic. We thought of changing it up this week to share how our team is working with customers during these unprecedented times. With today’s capricious working culture, here are some practices we are implementing with our loyal customers: Click here to learn more about what Cloudbyz CTMS can do for your organization or request a virtual demo today.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.