Sat.May 16, 2020 - Fri.May 22, 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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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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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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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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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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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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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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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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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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The Problem With Staying at Your Job too Long

ECRG Media's Clinical Research Podcast

The Problem With Staying At Your Job Too Long 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 i

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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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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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Community means the world to ClientPharma

Client Pharma

Client-Pharma is committed to providing a first-class service to clients all over the world, and closer to home they pledged to serve the local community that emulates their core company values. Since the UK lock-down began, Client-Pharma teamed up with a local restaurant to provide fresh hot meals daily for neighborhoods in a local town close to the office HQ.

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Amphista Therapeutics appoints leading protein degradation pioneer, Ian Churcher as CSO

Drug Discovery Today

Glasgow, Scotland, 21 May 2020 - Amphista Therapeutics, a biopharmaceutical company creating first-in-class cancer therapeutics that harness the body’s natural processes to remove disease causing proteins selectively and efficiently, today announced the appointment of Dr Ian Churcher as Chief Scientific Officer (CSO).

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The Problem With Staying at Your Job too Long

ECRG Media's Clinical Research Podcast

The Problem With Staying At Your Job Too Long. 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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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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Electronic Prescription Management and Enrollment for Specialty Medications—Expanding Provider Adoption of Tech-Enabled Hub Services

Drug Channels

Today’s guest post comes from Kyle Grimslid, Market Development Director at CoverMyMeds. Kyle describes the complications that providers and patients encounter in the specialty prescription process. He describes how AMP: Access for more Patients™ enhances access, affordability and adherence—including a reported 27% reduction in time to therapy. Click here to learn more about how CoverMyMeds and RxCrossroads by McKesson are using technology to solve patients' medication access challenges.

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Community means the world to Client-Pharma

Client Pharma

Client-Pharma is committed to providing a first-class service to clients all over the world, and closer to home they pledged to serve the local community that emulates their core company values. Since the UK lock-down began, Client-Pharma teamed up with a local restaurant to provide fresh hot meals daily for neighborhoods in a local town close to the office HQ.

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Our Commitment To You During COVID-19

Pharma Packaging Solutions

We are monitoring the COVID-19 situation very closely. We are confident we can abide by any imposed guidelines while continuing to seamlessly support our customers’ business operations. Because we care about our associates, our customers and our communities, we want to share the steps we are taking during this fluid and changing situation. We do have an active business continuity plan to keep our customers, our visitors, our associates and their families safe and healthy.

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MINI REVIEW OF SCOTT CRANIODIGITAL SYNDROME

Pharma Tutor

AUTHORS : Gouranga Sundar Roy 1 *, Sangita Biswas 2 . Department of Pharmacy, Bengal School of Technology. (A College of Pharmacy), Sugandha, Delhi Road Near Chuchura, Hooghly - 712102, West Bengal, India. ABSTRACT: Scott Craniodigital syndrome is a situation that has best been found in families. The manifestations consist of uncommon head shape, boom and developmental delay, and mild webbing between the arms and toes.

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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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Vaccines Manufacturing and Innovation Centre (VMIC) Given Go Ahead to Create ‘Virtual VMIC’, Whilst in Tandem Expanding and Fast-tracking Permanent Vaccines Facility

Drug Discovery Today

A ‘virtual VMIC’ will be created to rapidly expand the UK capacity to manufacture a COVID-19 vaccine. VMIC’s permanent facility, currently being built, will be fast tracked to come online in Summer 2021 – a year ahead of schedule. Manufacturing output at the permanent facility will be scaled-up 20fold to ensure enough doses of a pandemic vaccine for the UK population within 4-6 months of opening.

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Rentschler Biopharma licenses Horizon Discovery’s CHOSOURCE platform to complement cell line development offering for difficult-to-express proteins

Drug Discovery Today

CHOSOURCE platform to be combined with Rentschler Biopharma’s novel in-house cell line development process to provide speed, stability and high yield

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NanoMab Enters into Agreement with University Hospital Aachen to initiate a Cancer Therapy Programme utilising next generation NM-02 radiopharmaceutical product.

Drug Discovery Today

Translational Programme established for FIH late stage HER2 positive breast cancer in Q4 2020